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\begin{document}

\title{Effects of a standardized information booklet on patient anxiety and
satisfaction with information at magnetic resonance imaging: a
randomized single-blind placebo-controlled trail}



\author[1]{Anetta Bolejko}%
\author[2]{Peter Hagell}%
\affil[1]{Lund Univ}%
\affil[2]{Kristianstad University}%


\vspace{-1em}



  
  \date{May 05, 2024}


\begingroup
\let\center\flushleft
\let\endcenter\endflushleft
\maketitle
\endgroup





\selectlanguage{english}
\begin{abstract}
Rationale, aims and objectives; Magnetic resonance imaging (MRI) can be
perceived as unpleasant even though the examination is noninvasive.
Patients' knowledge of the MRI procedure is usually scarce, which might
enhance patient anxiety at the examination. The aims of this randomized
single-blind placebo-controlled trial were to investigate the effects on
anxiety and satisfaction with information of a standardized booklet on
MRI compared to a placebo booklet delivered to adult patients prior to
their first MRI examination. Method; The intervention group (n=95)
received a standardized booklet prior to MRI, while the control group
(n=102) received a placebo booklet in the same size and lay out but
containing general information. The State Trait Anxiety Inventory (STAI)
with supplementary questions from the Quality from the Patient's
Perspective questionnaire were used as the patient-reported outcome
measures. Results; There was no significant difference in anxiety
between the groups, either prior to MRI or during the examination, but
those who received the placebo booklet were at higher risk of
experiencing high anxiety prior to the MRI examination (odds ratio,
2.64; P=0.029). The intervention group was more satisfied with the
information received (P=0.044), and a majority of participants in both
groups ([?]87\%) considered it important to obtain information on the MRI
procedure. Conclusion; Standardized written MRI information decreases
the risk of experiencing high anxiety levels before MRI and improves
patients' satisfaction with the information. Further research is needed
to investigate whether written information prior to MRI is beneficial
not only from the patient perspective but if it can also be proven
cost-effective.%
\end{abstract}%



\sloppy




\textbf{Introduction}

Magnetic resonance imaging (MRI) is an important modality in diagnostics
and treatment follow-up. A common non-open MRI camera consists of a
tunnel approximately 1.6 m long and 0.6 m in diameter surrounded by the
magnet \textsuperscript{1-2}. The patient lies isolated in the camera
during the examination which lasts for approximately 30-60 minutes. The
noise level during the examination is high, between 65 and 95 decibels
depending on the MRI equipment and procedure, thus ear protection is
used during the examination. Although noninvasive, MRI may therefore be
perceived as unpleasant and stressful \textsuperscript{3}. For example,
experiences of fear and a threat of losing self-control have been
described during MRI \textsuperscript{4-5}, and 14\% of patients
experience severe anxiety and fear in MRI \textsuperscript{6}. Several
studies reported that up to 15\% of patients terminate their MRI due to
anxiety and feelings of claustrophobia during the
examination\textsuperscript{7-10}. Features of MRI equipment and its
strange environment have been described as sources of
distress\textsuperscript{4-6}.

Various measures aiming to alleviate patient discomfort have been
investigated \textsuperscript{11}; for example,
premedication\textsuperscript{9}, relaxation exercises
\textsuperscript{12-14}, hypnosis \textsuperscript{15}, a visit prior to
MRI\textsuperscript{16}, extensive oral information and
counselling\textsuperscript{14, 17}, and a telephone contact or a video
demonstration of the procedure prior to the
examination\textsuperscript{18-19}. Most of these interventions are time
consuming and rather complex to provide in clinical practice. Using a
questionnaire to identify whether a person has claustrophobia has been
suggested \textsuperscript{20-21}, and persons with claustrophobia may
then be examined in an open magnet \textsuperscript{22-24} or receive
premedication \textsuperscript{9}. However, open magnets have
limitations \textsuperscript{25} and using sedatives may be inconvenient
for outpatients due to side effects, and if sedatives are given
intravenously, monitoring of the patient also needs to be
considered\textsuperscript{26}.

Lack of information can worsen anxiety at MRI \textsuperscript{27-28}.
However, patients' knowledge of how MRI is conducted is usually scarce
and the source of information is often relatives \textsuperscript{29},
which points to the need for accurate and standardized pre-scanning
information. For example, written information before an MRI has been
found needed and welcomed by patients \textsuperscript{3, 30}, and an
information booklet would be a simple and inexpensive means to
ameliorate the discomfort that might be experienced. It has been
stressed that such written patient information should contain several
types of information, i.e., procedural (how the examination/treatment is
carried out), behavioral (how the patient can cooperate), and sensory
(what the patient may experience) information \textsuperscript{31}.

However, the evidence regarding the potential effects of a simple
intervention such as an information booklet delivered to the patient
prior to the MRI examination is scarce. One non-randomized study used
written information but in combination with other
measures\textsuperscript{16} and found reduced anxiety levels during
scanning. Another non-randomized study failed to demonstrate any
differences in anxiety or satisfaction with the information between
groups receiving standard vs. extended pre-scan written information,
although motion artefacts in the MRI images were fewer in the latter
group\textsuperscript{32}.

The aim of this randomized single-blind placebo-controlled trial was to
investigate the effects of a standardized information booklet on patient
anxiety and satisfaction with information in connection with MRI.
Specifically, the following hypotheses were investigated.

\begin{enumerate}
\tightlist
\item
  A standardized information booklet on MRI decreases patient anxiety
  prior to and during MRI scanning.
\item
  A standardized information booklet on MRI increases patient
  satisfaction with information about the procedure.
\end{enumerate}

\textbf{Methods}

The study was conducted in accordance with the Declaration of Helsinki
and was reviewed by the local ethics advisory committee. All
participants gave their informed consent.

Design

This is a placebo-controlled single-blind randomized controlled trial on
the effects of standardized written information in comparison with a
placebo intervention on patient anxiety and satisfaction with
information among adults undergoing an MRI examination for the first
time.

Sample

Study participants were consecutively recruited during 18 months at the
Department of Medical Imaging and Physiology at University Hospital in
Malm\selectlanguage{ngerman}ö, Sweden. The department has 4 MRIs and performs approximately 5000
outpatient MRI examinations each year. The inclusion criteria were
outpatients aged 18-70 years who were to undergo an MRI examination
using a non-open camera Siemens Symphony 1.5 Tesla MRI scanner.
Inpatients, those who previously had undergone an MRI examination, those
who were to undergo MRI in anesthesia, patients with cognitive
impairment, and those who did not speak Swedish were excluded. The study
participants were randomized to either an intervention or control group.
The flow chart of the study sample is presented in Figure 1.

Figure 1 about here

The sample size was estimated a priori based on previous study results
regarding anxiety, as assessed using the State Trait Anxiety Inventory
(STAI); pre-scanning mean scores in the intervention and control groups
were estimated to be 37 and 41, respectively, and scores after MRI were
estimated to be 32 and 37, respectively, with a common SD of 10. Based
on these parameters, which give effect sizes of 0.4 and 0.5,
respectively, approximately 99 and 64 individuals were required per
group for 80\% power at a two-tailed alpha level of
0.05\textsuperscript{33}.

Intervention

The active intervention consisted of an information booklet on MRI that
was developed based on clinical experience, relevant literature, and
patient input \textsuperscript{31}. Briefly, the booklet contained the
following information:

- explanation of how an MRT examination is conducted (procedure
information)

- description of what might be expected by the patient in connection to
the MRI procedure (behavior information)

- examples of potential reactions and experiences in connection to MRT
(sensory information)

The placebo intervention consisted of an information booklet of the same
size and layout as the intervention booklet, but only containing general
information about the department and no specific information about the
MRI procedure.

In addition to the booklets, both groups received standard care. This
consists of checking responses to a safety questionnaire that patients
complete before the appointment. This is followed by oral information
about the examination (e.g., duration of the examination, the need to
lie still, and that a loud noise will be heard when images are taken).
If the procedure requires the patient to hold her/his breath, this is
practiced prior to the examination. Ear protection is applied and those
who wish so are offered to listen to music. Everyone gets an alarm clock
to call on the staff if needed. Relatives are welcome to be present in
the examination room but have no opportunity to communicate with the
patient. The time to give the above information is limited to
approximately 5 minutes. Upon completion of the MRI, the patient is
informed that the results will be sent to the referring physician.

Instruments and other study data

Anxiety was assessed using the STAI, which consists of two parts: STAI
FORM Y-2 T and STAI FORM Y-1 S \textsuperscript{34}. STAI FORM Y-2 T
(''trait anxiety''), assesses the individual's general tendency to
experience stressful situations as worrying, and STAI FORM Y-1 S
(''state anxiety'') assesses the current anxiety levels (ibid). STAI
FORM Y-1 S is available in two different designs; one is worded in
present tense and intends to assess the respondent's anxiety right now
and the other is worded in past tense and intends to assess recently
perceived anxiety. These STAI forms are hereinafter referred to as
STAI-T (trait anxiety), STAI-SB and STAI-SA (state anxiety before and
immediately after MRI, respectively, where the STAI-SA was intended to
assess anxiety experienced during the MRI). All STAI forms comprise 20
items each with four ordered response categories scored 1-4, yielding
possible total scores between 20 (less anxiety) and 80 (more anxiety). A
total score of 40 or higher is considered to indicate a high level of
anxiety\textsuperscript{16, 32}. In cases of \selectlanguage{english}[?]10\% missing item
responses, scores are imputed by averaging item scores across available
item responses \textsuperscript{34}.

The STAI has been used in a variety of areas, including the assessment
of anxiety in the context of MRI scanning \textsuperscript{12-13, 16-17,
19, 23-24, 32, 35}. There is general support for the validity and
reliability of scores on the different STAI forms \textsuperscript{36}.
In the present study, the Swedish version \textsuperscript{37} of the
instrument was used. Cronbach's coefficient alpha in the control and
intervention groups in this study was 0.94 and 0.92 for STAI-T, 0.93 and
0.94 for STAI-SB, and 0.94 and 0.93 for STAI-SA, respectively.

Satisfaction with the information about MRI was assessed using three
study specific items. The first question concerned the agreement between
the patient's expectations of the examination and the actual experience.
The two other questions were adapted from the Quality from the Patient's
Perspective questionnaire for mammography \textsuperscript{38} and
concerned whether the pre-scan information made them understand what was
going to happen, and how important the patient considers such
information to be. All three questions had four ordered response
categories scored 1-4, where 4 represents a higher degree of
satisfaction.

In addition, it was recorded whether or not sedatives were taken prior
to the MRI examination, relatives were present in the examination room,
and if the patient listened to music during the examination. Other data
recorded were age, gender, duration of the examination, scanned body
part, if the patient called or visited the MRI department before the
examination, if the patient aborted the examination, and medical history
(classified as malignant or other disease) at referral.

Data collection

An invitation to participate was sent together with the call letter for
the MRI examination. Those who wished to participate were asked to sign
and return a written informed consent together with the completed
STAI-T. To mimic routine clinical use of the written MRI information as
far as possible, those randomized to the intervention group received the
MRI information booklet together with the call letter and the control
group received the placebo booklet.

All staff at the MRI unit were fully informed about the study but were
blinded to which group patients belonged to. Prior to MRI, all patients
were asked to complete the STAI-SB and sealed it in an envelope, before
being provided standard care (see above). Immediately after completion
of the MRI, patients were asked to complete the STAI-SA as well as the
three satisfaction questions, which also were returned in sealed
envelopes. Patients who aborted the examination prematurely were also
asked if they were willing to answer the questionnaires.

Data analysis

Data were analyzed using IBM SPSS Statistics 25, with the two-tailed
significance level set to P\textless{}0.05. Demographic data, intake of
sedatives, the presence of relatives in the MRI room, whether the
patients listened to music in connection to the examination, STAI-T
scores, and other baseline data were analyzed using chi-square/Fisher's
exact tests, Mann-Whitney U tests and independent t-tests, as
appropriate. Mann-Whitney U and Wilcoxon signed-rank tests were used for
between and within group comparisons of STAI-SB and STAI-SA scores, and
Mann-Whitney U tests were used to compare satisfaction scores.

The proportion of patients with STAI-SB and STAI-SA total scores of 40
or more was compared between the intervention and control groups using
chi-square tests. To examine whether the intervention booklet was
associated with a lower risk of high anxiety immediately before and
during MRI scanning, a multivariate logistic regression (forward
stepwise) was performed, using dichotomized STAI-SB and STAI-SA total
scores (\textless{}40 = 0; \selectlanguage{english}[?]40 = 1) as dependent variables. Group
assignment (intervention or control), high trait anxiety (STAI-T \selectlanguage{english}[?]40),
gender, telephone contact or visiting MRI prior to the examination, use
of sedatives prior to MRI, presence of relatives in the examination
room, music during the examination, and medical history were entered as
independent variables.

\textbf{Results}

The study sample consisted of 109 (55\%) women and 88 (45\%) men. Other
demographic data is presented in Table 1. Five people in the
intervention group but none in the control group visited the MRI unit
prior to their scheduled examination. No other group differences were
found regarding demographic and other sample characteristics, including
general tendency to experience anxiety (STAI-T scores).

Table 1 about here

Anxiety prior to and during MRI

There was no significant difference in anxiety between the intervention
and control group, either prior to MRI or during the examination (Table
2). Both groups showed significantly lower anxiety during MRI compared
to immediately before the examination. Group comparisons were also
conducted excluding the patients in the intervention group who visited
the MRI unit prior to the examination. The analysis yielded median
(q\textsubscript{1}-q\textsubscript{3}) STAI-SB (n=79) and STAI-SA
(n=75) scores of 32 (25-39) and 27 (22-37) for the intervention group.
Compared to the control group (Table 2), these results gave P-values of
0.231 and 0.421 for the STAI-SB and STAI-SA, respectively.

Table 2 about here

Thirty-three respondents (39\%) in the control group and 22 (25\%) in
the intervention group had a total STAI-SB score \selectlanguage{english}[?]40 (P=0.124;
chi-square test). For the STAI-SA, equal numbers of respondents in both
groups (n=17) had a total score \selectlanguage{english}[?]40 (P=0.843; chi-square test). Logistic
regression demonstrated that high trait anxiety (total STAI-T scores
\selectlanguage{english}[?]40), having visited the MRI unit prior to the examination, presence of
relatives at in the examination room, and receiving the placebo
intervention rather than the MRI information booklet were associated
with high levels of pre-scan anxiety (Table 3). High anxiety levels
during scanning (STAI-SA scores \selectlanguage{english}[?]40) were associated with high trait
anxiety and having called the MRI unit prior to the examination (Table
3).

Table 3 about here

Satisfaction with information

Participants in both groups found pre-scan information to be of
importance (median {[}q1-q3{]}, 4 {[}3-4{]} in both groups; P=0.837;
Mann-Whitney U-test). Both groups also considered their expectations of
the examination to agree with their experiences (median {[}q1-q3{]}, 3
{[}2-4{]} and 3 {[}3-4{]} for the control and intervention groups,
respectively; P=0.253; Mann-Whitney U-test). However, the intervention
group was more satisfied with the given information (median {[}q1-q3{]},
4 {[}4-4{]}) than the control group was (4 {[}3-4{]}; P=0.044;
Mann-Whitney U-test).

\textbf{Discussion}

In this randomized single-blind placebo-controlled trial the effects of
a standardized MRI information booklet on anxiety and satisfaction with
information among adult outpatients undergoing their first MRI
examination was investigated. There were no differences in anxiety
between the intervention and control groups before or during scanning,
but those who received the placebo booklet had a significantly higher
risk of experiencing severe anxiety immediately prior to MRI. The
results also showed that pre-scanning information is considered
important, and that those who received MRI specific written information
before their examination were more satisfied than those who received
general information.

The effects of written patient information on elevating patient anxiety
associated with MRI have been investigated before using the STAI
questionnaire \textsuperscript{16, 32}. One study found significantly
decreased anxiety during MRI among patients who received an information
booklet in comparison with those who did not \textsuperscript{16}.
However, the written information in that study was supplemented by other
interventions such as a pre-scan counselling, which makes it uncertain
to what extent the outcomes can be attributed to the written
information\emph{per se} . Another study failed to demonstrate any
reduction in MRI-associated anxiety from provision of an information
booklet alone\textsuperscript{32}. This may have been due to providing
written MRI information to both study groups and only supplemental
information to the experimental group \textsuperscript{32}. However, the
present study demonstrates that those who received the placebo booklet
had a higher risk of experiencing high pre-scan anxiety compared to
those who received specific MRI information. This association was
independent and beyond those of high baseline anxiety levels, pre-scan
visits to the MRI and the presence of relatives during scanning.
Furthermore, factors such as cause of referral, use of sedatives and
gender, which all have been found associated with MRI anxiety in
previous studies\textsuperscript{9, 19, 32}, did not contribute to high
anxiety levels once the written information was taken into account.
These findings are strengthened by the randomized placebo-controlled
design, which differs from previous quasi-experimental studies of the
effects of written information on MRI associated anxiety
\textsuperscript{16, 32}.

The comparison within the groups regarding patient perceived anxiety
prior to and during the MRI showed significant differences for both
groups. This may be due to a feeling of relief after the examination.
That is, although STAI-SA intended to assess anxiety during the
examination, it cannot be ruled out that responses may have been
influenced by perceptions at the time when the inventory was answered.
Furthermore, attendance and oral information by the staff (which was
provided after the STAI-SB was responded to) may also have had an
anxiety reducing effect \textsuperscript{4-5, 39}. For example, it has
been found that support from the staff have a significant impact on
patients` experiences of an MRI and the staff/patient interaction may
facilitate self-control and coping during the
examination\textsuperscript{4}.

The intervention group was more satisfied with the information compared
to the control group, which is contrary to previous results in
MRI\textsuperscript{32}. This could be explained that our study provided
a booklet that was developed in interaction with people who had
undergone an MRI, which probably enhances the relevance and
comprehension of the information \textsuperscript{31}.

A placebo booklet was applied, which is considered a strength of the
study. Nevertheless, there is also a risk to use placebo considering
that the attention provided by the placebo booklet may have affected
their experiences of MRI, even though it did not include any information
about the examination. However, it has been argued that these effects
are negligible in interventions of patient education that are applied
over a short period of time \textsuperscript{40}. Indeed, the Nordic
Cochrane Centre concluded that in general there is no evidence that
placebo interventions have clinical effect with an exception of possible
influence on experiences of pain and nausea \textsuperscript{41}.

One aspect that always should be considered in relation to any
intervention is its cost-effectiveness. That is, whether the extra cost
associated with printing and distributing an MRI information booklet is
compensated by its effects. To the best of our knowledge, there is no
such evidence available regarding written information prior to MRI.
However, it appears reasonable to consider the relatively small costs to
be acceptable in view of the results presented here, particularly since
previous studies have suggested that this type of intervention also may
reduce motion artefacts \textsuperscript{32, 42}. Nevertheless, future
studies should consider cost-effectiveness in addition to motion
artefacts and MRI associated anxiety and wellbeing \textsuperscript{43}.

Conclusion

This placebo-controlled single-blind randomized trial examined the
effects of standardized written information to people undergoing their
first MRI examination. The results showed that such information reduces
the risk of experiencing high pre-scanning anxiety levels, that patients
find it important to receive information before the examination, and
that it increases the satisfaction with the information as compared to
general information.

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\end{enumerate}

\textbf{Acknowledgments}

The authors would like to thank the Department of Medical Imaging and
Physiology in Malmo for the possibility to conduct the study. We are
also grateful to the staff at the department for their help in
collecting patient self-report questionnaires.

\textbf{Conflicts of interest statement}

No conflict of interest

Table 1. Demographic data and other characteristics of the study groups.\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
Intervention group n=95\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
Control group n=102\strut
\end{minipage} & \begin{minipage}[b]{0.24\columnwidth}\raggedright\strut
P-value\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Gender, man/woman, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
43 (45) / 52 (55)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
45 (44) / 57 (56)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.872 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Age (years), mean (SD)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
48.7 (12.9)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
49.4 (13.0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.686 \textsuperscript{++}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Duration of MRI (minutes), mean (SD)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
34.0 (13.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
34.3 (16.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.857 \textsuperscript{++}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Aborted MRI, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
2 (2.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
4 (3.9)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.684 \selectlanguage{ngerman}\textsuperscript{§}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Telephone call prior to MRI, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
13 (13.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
7 (6.9)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.113 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Visit prior to MRI, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
5 (5.3)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0 (0)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.025 \selectlanguage{ngerman}\textsuperscript{§}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Sedatives prior MRI, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
5 (5.3)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
8 (7.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.476 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Relatives present in the MRI room, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
10 (10.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
13 (12.7)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.609 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Music during MRI, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
58 (62.1)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
63 (61.8)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.939 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Referral diagnosis, malignancy/other, n (\%)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
28 (29.5) / 67 (70.5)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
29 (28.4) / 73 (71.6)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.872 \textsuperscript{+}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
Trait anxiety (STAI-T), median (q\textsubscript{1} --
q\textsubscript{3})\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
33 (28 - 43)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
33 (27 -- 44)\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.850 \textsuperscript{PP}\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Investigated bodypart, n (\%) Head Thorax/abdomen Spine Upper extremity
Lower extremity\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
38 (40.0) 25 (26.3) 16 (16.8) 4 (4.2) 12 (12.6)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
31 (30.4) 24 (23.5) 24 (23.5) 1 (1.0) 22 (21.6)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
0.154 \selectlanguage{ngerman}\textsuperscript{§}\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}\selectlanguage{ngerman}

\selectlanguage{english}\textsuperscript{+} Chi-square test; \selectlanguage{english}\textsuperscript{++}
T-test;\textsuperscript{SS} Fisher`s exact test;
\selectlanguage{english}\textsuperscript{PP}Mann-Whitney U-test MRI, magnetic resonance imaging;
SD, standard deviation; q\textsubscript{1} - q\textsubscript{3},
25\textsuperscript{th} to 75\textsuperscript{th} percentiles

Table 2. State anxiety before and after MRI as compared between and
within groups.\selectlanguage{english}
\begin{longtable}[]{@{}llll@{}}
\toprule
\begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
STAI-SB\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
STAI-SA\strut
\end{minipage} & \begin{minipage}[b]{0.22\columnwidth}\raggedright\strut
P-value \textsuperscript{++}\strut
\end{minipage}\tabularnewline
\midrule
\endhead
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Intervention group, n median
(q\textsubscript{1}-q\textsubscript{3})\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
n=84 32.8 (26.0 -- 41.0)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
n=80 27.5 (22.0 -- 37.5)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
0.002\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
Control group, n median (q\textsubscript{1}-q\textsubscript{3})\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
n=89 35.0 (27.0 -- 42.6)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
n=85 30.0 (21.0 -- 37.4)\strut
\end{minipage} & \begin{minipage}[t]{0.24\columnwidth}\raggedright\strut
\textless{}0.001\strut
\end{minipage}\tabularnewline
\begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
P-value \textsuperscript{+}\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.437\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
0.694\strut
\end{minipage} & \begin{minipage}[t]{0.22\columnwidth}\raggedright\strut
\strut
\end{minipage}\tabularnewline
\bottomrule
\end{longtable}

\textsuperscript{+} Mann-Whitney U-test

\textsuperscript{++} Wilcoxon test

MRI, magnetic resonance imaging; STAI-SB, state anxiety before scanning;
STAI-SA, state anxiety during scanning; q\textsubscript{1} -
q\textsubscript{3}, 25\textsuperscript{th} to
75\textsuperscript{th}percentiles

Table 3. Multivariate logistic model\textsuperscript{+} of predictors
for high anxiety levels ([?]40) prior to (STAI-SB) and during (STAI-SA)
MRI examination.\selectlanguage{english}
\begin{longtable}[]{@{}lllll@{}}
\toprule
Anxiety \textsuperscript{++} & Significant predictors \selectlanguage{ngerman}\textsuperscript{§}
& B (SE) & P-value & Odds ratio (95\% CI)\tabularnewline
STAI-SB & High trait anxiety (STAI-T) & 2.36 (0.44) & \textless{}0.001 &
10.64 (4.45, 25.40)\tabularnewline
& Visit prior to MRI & 3.44 (1.28) & 0.007 & 31.06 (2.55,
378.88)\tabularnewline
& Relatives present in the MRI room & 1.46 (0.59) & 0.013 & 4.31 (1.36,
13.69)\tabularnewline
& Placebo intervention & 0.97 (0.45) & 0.029 & 2.64 (1.10,
6.33)\tabularnewline
STAI-SA & High trait anxiety (STAI-T) & 1.26 (0.42) & 0.003 & 3.54
(1.55, 8.05)\tabularnewline
& Telephone call prior to MRI & 1.27 (0.42) & 0.023 & 3.57 (1.19,
10.70)\tabularnewline
\bottomrule
\end{longtable}

\textsuperscript{+} Forward stepwise (likelihood-ratio) multivariate
logistic regression

\textsuperscript{++} Dichotomized total score according to the cut-off
value (\textless{}40 = 0; [?]40 = 1)

\selectlanguage{ngerman}\textsuperscript{§} Independent variables entered into the model: gender
(man = 0, woman = 1), visit prior to MRI (No = 0, Yes = 1), telephone
call prior to MRI (No = 0, Yes = 1), sedatives prior to MRI (No = 0, Yes
= 1), relatives present in the MRI room (No = 0, Yes = 1), music during
MRI (No = 0, Yes = 1), referral diagnosis (malignancy = 1, other disease
= 0), high trait anxiety (STAI-T total score \textless{}40 = 0, STAI-T
total score \selectlanguage{english}[?]40 = 1), group affiliation (intervention group = 0, control
group = 1). Independent variables that are not presented in the table
were not significantly associated with experiencing high anxiety levels.

Hosmer-Lemeshow goodness-of-fit test, P=0.601; Nagelkerke`s pseudo
R-square, 0.399 (STAI-SB);

Hosmer-Lemeshow goodness-of-fit test, P=0.371; Nagelkerke`s pseudo
R-square, 0.149 (STAI-SA).

B, regression coefficient; SE, standard error; 95\% CI, 95\% confidence
interval; MRI, magnetic resonance imaging; STAI-SB, state anxiety before
scanning; STAI-SA, state anxiety during scanning

\textbf{Figure legends}

Figure 1: Flow chart of the study sample.

\textbf{Hosted file}

\verb`Figure 1.docx`  available at \url{https://authorea.com/users/302269/articles/432298-effects-of-a-standardized-information-booklet-on-patient-anxiety-and-satisfaction-with-information-at-magnetic-resonance-imaging-a-randomized-single-blind-placebo-controlled-trail}

\selectlanguage{english}
\FloatBarrier
\end{document}

