Comparison of the effectiveness of music therapy and hand-holding on perceived stress and pain of patients undergoing endoscopy referring to Rafsanjan Gastroenterology Clinic
Comparison of the effect of music therapy with hand holding on stress and pain levels of patients undergoing endoscopy
Design
Clinical trial with parallel groups, single-blind, randomized, on 64 patients. A lottery method was used for randomization.
Settings and conduct
This study will be conducted in the endoscopy department of Ali Ibn Abitaleb Hospital of Rafsanjan in 2022. After providing the necessary explanations and obtaining informed consent, the subjects entered the study and completed the perceived stress questionnaire, the visual pain scale and the study checklist. Then, based on the random allocation table obtained by using random allocation software, they are assigned to one of three groups. The first group will listen to nature music through headphones during the endoscopy. The second group will have their hand in the hand of their companion during the endoscopy process. The third group will not receive any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: informed consent to participate in the study; age: 15-55 years old; ability to speak and understand Farsi; full alertness; healthy hearing and vision; no history of gastrointestinal endoscopy; no history of high blood pressure under medical treatment. Exclusion criteria: unwillingness to continue cooperation in the study.
Intervention groups
Intervention group 1: This group will undergo music therapy.
Intervention group 2: This group will be subjected to hand holding.
Main outcome variables
Change in the amount of stress; pain level
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150317021497N8
Registration date:2022-10-09, 1401/07/17
Registration timing:prospective
Last update:2022-10-09, 1401/07/17
Update count:0
Registration date
2022-10-09, 1401/07/17
Registrant information
Name
Mohammadreza Mokhtaree
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34260081
Email address
mrmokhtaree@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-20, 1401/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of music therapy and hand-holding on perceived stress and pain of patients undergoing endoscopy referring to Rafsanjan Gastroenterology Clinic
Public title
Comparison of the effectiveness of music therapy and hand-holding on stress and pain of patients undergoing endoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to speak and understand Farsi language
Full consciousness
Hearing and vision health
Exclusion criteria:
History of gastrointestinal endoscopy
History of high blood pressure under medical treatment
Unwillingness to continue cooperation in the study
Age
From 15 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer software (Random Allocation), patients are placed in three groups of music therapy, hand-holding, or control through four blocks with an allocation ratio of 1:1:1. During the endoscopy procedure, the music therapy group will listen to nature music through headphones. The hand-holding group will have their hand in their companion's hand during the endoscopy process, and the control group will not receive any of these two interventions. The random allocation sequence will be generated by a person not involved in the research. Both groups will receive routine treatments.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Rafsanjan University of Medical Sciences
Street address
University of medical sciences, Imam Ali Blvd., Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Approval date
2020-12-12, 1399/09/22
Ethics committee reference number
IR.RUMS.REC.1399.212
Health conditions studied
1
Description of health condition studied
Peptic Ulcer
ICD-10 code
K27
ICD-10 code description
Peptic ulcer, site unspecified
2
Description of health condition studied
Dyspepsia
ICD-10 code
K30
ICD-10 code description
Functional dyspepsia
3
Description of health condition studied
Duodenal ulcer
ICD-10 code
K26
ICD-10 code description
Duodenal ulcer
4
Description of health condition studied
Gastrointestinal hemorrhage
ICD-10 code
K92.2
ICD-10 code description
Gastrointestinal hemorrhage, unspecified
Primary outcomes
1
Description
Stress score in perceived stress questionnaire
Timepoint
Stress measurement before the intervention and 2 hours after the completion of the intervention process
Method of measurement
Cohen's Perceived Stress Questionnaire
2
Description
Pain score on visual pain scale
Timepoint
Pain assessment before the intervention and 2 hours after the completion of the intervention process
Method of measurement
Visual pain scale
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: listening to a nature background music through headphones during endoscopy process
Category
Rehabilitation
2
Description
The second intervention group: partner's hand holding during the endoscopy process
Category
Rehabilitation
3
Description
Control group: without any intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ibn Abi-Talib Hospital
Full name of responsible person
Vahid Mirzaee
Street address
Ali Ibn Abi-Talib Hospital, Imam Ali Blvd, Rafsanjan Town
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
name@domian.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Reza Vazirinejad
Street address
Building No. 3, Research and Technology chancellor, Rafsanjan University of Medical Science, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717933777
Phone
+98 34 3428 0038
Email
vcrt@rums.ac.ir
Web page address
https://vcrt.rums.ac.ir/home
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid Mirzaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult gastroenterology and hepatology
Street address
Ali Ibn Abi-talib hospital, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
vah_mirzaee@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Vahid Mirzaee
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Adult gastroenterology and hepatology
Street address
Ali Ibn Abi-Talib Hospital, Imam Ali Blvd
City
Rafsanjan
Province
Kerman
Postal code
7717937555
Phone
+98 34 3428 0000
Email
vah_mirzaee@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohammadreza Mokhtaree
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Moradi hospital, Shohada ST
City
Rafsanjan
Province
Kerman
Postal code
7713961151
Phone
+98 34 3426 0080
Fax
Email
mrmokhtaree@rums.ac.ir
Web page address
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
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Commitment to the principle of fiduciary
From where data/document is obtainable
Sending an official letter to the Research Vice-Chancellor of Rafsanjan University of Medical Sciences
What processes are involved for a request to access data/document
After the approval of the research vice-chancellor of Rafsanjan University of Medical Sciences, the data will be provided to the applicant.