Investigating the effect of playing audio-visual translation clips of the Holy Quran on the anxiety level and hemodynamic parameters of patients before mastectomy surgery: A Randomized Clinical Trial
Determining the effect of audio-visual translation of the Holy Quran on the level of anxiety and hemodynamic status of patients before mastectomy surgery
Design
The clinical trial has a control group with parallel groups, double-blind, randomized on 48 people and for randomization using the computer software Random Allocation Software (RAS) version 4/9 (Internet address: https://random-allocation-software.software.informer.com/2.0/) will be used.
Settings and conduct
Place of study: Hospitals affiliated to Shiraz University of Medical Sciences
A double-blind (statistical evaluator and analyst).
Available sampling to saturation of samples.
After randomly allocating the patients, in the intervention group, by placing the headphones, the audio-visual translation of the Holy Quran will be played for each patient for 10 minutes, and then the hemodynamic symptoms will be measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
At least 18 years old or older, Being a Muslim and believing in the Quran
Being, literate in reading and writing
Exclusion criteria:
presence of hearing and vision disorders; The average anxiety score is above 20; the presence of a known anxiety disorder; use of sedatives or hypnotics; Addiction to drugs; blood pressure more than 140/90 mmHg and not taking medicine; history of other underlying diseases; Previous surgery for breast cancer
Intervention groups
In the intervention group, by inserting wireless headphones using a Samsung brand tablet, a video file of audio translation of the Holy Quran will be played for each patient for 10 minutes And then hemodynamic symptoms will be measured. Control group: The patients of the control group will not be given headphones and will only complete the questionnaire and their hemodynamic symptoms will be evaluated.
Investigating the effect of playing audio-visual translation clips of the Holy Quran on the anxiety level and hemodynamic parameters of patients before mastectomy surgery: A Randomized Clinical Trial
Public title
Investigating the effect of Quran translation clips on patients' anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 18 years old
Being a Muslim and believing in the Quran
Being literate in reading and writing
The average anxiety score is above 20 according to the anxiety questionnaire
Having a stable hemodynamic state
Exclusion criteria:
Use of sedatives or sedatives during the study
Addiction to drugs such as opium and its derivatives
Blood pressure more than 140/90 mmHg and taking blood pressure medicine
History of cardiovascular disease, respiratory disease such as chronic obstructive pulmonary disease, thyroid gland disease, and the use of drugs that affect these diseases.
Previous surgery for breast cancer
Age
From 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Participants were randomly assigned to two control and intervention groups using Random Allocation Software (RAS) version 4/9 (web address: https://random-allocation-software.software.informer.com/2.0/) will be allocated. Random allocation is listed by permutation block method in block of 4 with random allocation software. In the randomization method using blocks, blocks with the combination of two letters A and B are defined at least 2 times the size of the groups (block size 4) and then the cards on which the blocks are written are randomly selected. we choose.
Blinding (investigator's opinion)
Double blinded
Blinding description
The researcher is an evaluator and data recorder, he is not aware of the grouping of people into intervention and control groups. Also, the statistical analyst does not know about this grouping, so the research will be double-blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Schools of Nursing and Midwifery, Management and Medical Information s
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.SUMS.NUMIMG.REC.1402.148
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
C-50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
The anxiety of patients before and after the intervention is measured by the Spielberger questionnaire.
The intervention that will be done for the intervention group is to play a clip of the translation of the Holy Quran through headphones for a person who is going to have a mastectomy.
Category
Treatment - Devices
2
Description
Control group: The control group does not receive any intervention. They will complete the anxiety questionnaire. Their hemodynamic monitoring will be done.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Namazi hospital
Full name of responsible person
Armin fereidouni
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammadhashem Hashempour
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3212 2430
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Armin fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Armin fereidouni
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
5.7 side alley; 5 alley; Dolate-sharghy Blvd.; Shiraz
City
Shiraz
Province
Fars
Postal code
7167755954
Phone
+98 71 3753 2383
Email
arminfereidoni@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Study data will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
By sending an email to the author responsible for the article, the data will be made available to experts in this field.
From where data/document is obtainable
En People can get the study data by sending an email to Armin Feridouni (author responsible for the article). Email: arminfereidoni@yahoo.com
What processes are involved for a request to access data/document
Ten days after receiving the email by the responsible author, the data will be available to the requesting person.