Determining the Effectiveness of Arandstein's Calming and Instrumental Music on Perceived Stress and Anxiety during MRIv
Design
Clinical trial with control group, parallel group, randomized, phase 2 on 50 patients. For randomization, the rand function of Excel software was used
Settings and conduct
This research is a quasi-experimental study with experimental and control groups and the statistical population includes all patients referred to the imaging department of Torbat Heydariyeh Hospital for MRI examination. Using statistical formula, 50 people will be divided into two groups (25 in experimental group and 25 in control group) (20). First, patients who referred to MRI from different areas of the body that meet the inclusion criteria will be included in the study. Sampling method of this design will be easy or available. After collecting the samples, the samples will be randomly assigned to two groups. Prior to MRI, Zhang Anxiety Scale (SAS) and Perceived Stress Scale (PSS) will be completed by both groups. If a person scores high on these two tests, they will be selected as a sample.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: high perceived anxiety and stress score, lack of mental disability, complete consciousness of the patient and lack of consciousness disorder (Alzheimer's, dementia, etc.). Output criteria include reluctance to participate in research
Intervention groups
1- Experimental group: Playing calming and speechless music of Arndstein during MRI
2- Control Group: No Intervention
The effect of relaxation and wordless music by Arnd Stein on anxiety and perceived stress during MRI
Public title
The effectiveness of music therapy on perceived anxiety and stress during MRI
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
High score of perceived anxiety and stress
Lack of mental disability
Complete consciousness of the patient and lack of consciousness disorder (Alzheimer, dementia,...)
Exclusion criteria:
Unwillingness to participate in research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be randomly assigned to two groups and random allocation will be done by random permutation block method.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Torbat Heydariyeh University of Medical Sciences
Street address
Razi Street Torbat Heydariyeh
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Approval date
2023-04-25, 1402/02/05
Ethics committee reference number
IR.THUMS.REC.1402.002
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia
2
Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction
Primary outcomes
1
Description
Anxiety
Timepoint
Before and immediately after the intervention (MRI)
Method of measurement
Self-Rating Anxiety Scale
2
Description
Stress
Timepoint
Before and immediately after the intervention (MRI)
Method of measurement
Cohen's Perceived Stress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Relaxation and wordless music by Arnd Stein
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Nohomdey Day Hospital
Full name of responsible person
DinpanahHossein
Street address
1st Gharni Street
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Phone
+98 51 5222 6016
Email
dinpanahh1@thums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Rezaie Manesh
Street address
Razi
City
Torbate Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Phone
+98 51 5222 6013
Email
rezayimaneshmr1@thums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Torbate-Heidaria University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Phone
+98 51 5222 6016
Email
ghodratia1@thums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Phone
+98 51 5222 6016
Email
ghodratia1@thums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Torbate-Heidaria University of Medical Sciences
Full name of responsible person
Abbas Ghodrati
Position
Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Razi
City
Torbat Heydariyeh
Province
Razavi Khorasan
Postal code
9515953196
Phone
+98 51 5222 6016
Email
ghodratia1@thums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD