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Design, implementation and evaluation, impact of playing music on physical and mental health status and satisfaction with service delivery in patients undergoing sutures referred to the outpatient operating room

Protocol summary

Study aim
Design, implementation and evaluation, the effect of playing music on physical and mental health status and satisfaction with the provision of services for patients under sutures referring to the outpatient operating room
Design
this study is a randomized controlled clinical trial of parallel type. Eligible patients are divided into two groups of 138 intervention and control.
Settings and conduct
In this study, traditional Iranian wordless music to be played for patients. In the intervention group, music will be played from the time the patient is placed on the bed until the suture is finished, and no music will be played in the control group. Pain will be measured with a VAS and anxiety will be measured with FAS and satisfaction based on patient's pulse rate in two stages after being placed on the bed and after finishing the sutures. The place of study is the emergency department of Imam Khomeini Hospital in Sari.
Participants/Inclusion and exclusion criteria
Inclusion criteria: being an adult aged 18-65 years old, not suffering from neuropathic or neuromuscular disease, not having mental, hearing, speech, physical motor and limb paralysis, not receiving painkillers for 12 hours before study, not having ruptures involving arteries, tendons and ligaments, not suffering from severe psychiatric disorders and under drug treatment, not suffering from cancer, not suffering from rheumatology disease and under drug treatment, not having ruptures due to self-harm, not having The presence of multiple tears, lack of opioid addiction.
Intervention groups
Intervention group: Music is played through the speaker by the researcher from the time the patient is placed on the bed for the suture and continues until the suture is completed.Control group: routine treatment is performed without playing music
Main outcome variables
Level of satisfaction, pain and anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20110906007494N46
Registration date: 2024-07-08, 1403/04/18
Registration timing: registered_while_recruiting

Last update: 2024-07-08, 1403/04/18
Update count: 0
Registration date
2024-07-08, 1403/04/18
Registrant information
Name
Masoumeh Bagheri Nesami
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7551
Email address
mbagheri@mazums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation and evaluation, impact of playing music on physical and mental health status and satisfaction with service delivery in patients undergoing sutures referred to the outpatient operating room
Public title
The effect of playing music on the health status and satisfaction in suture patients referred to the outpatient operating room
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study. Being an adult aged 18-65 years. Absence of neuropathic and neuromuscular disease No intellectual disability, hearing, speech, physical movement and limb paralysis Not receiving painkillers for 12 hours before the study Not having tears involving arteries, tendons and ligaments Not suffering from severe psychiatric disorders and under drug treatment No cancer Not suffering from rheumatology disease and under medical treatment Absence of rupture due to self-harm Absence of multiple tears and simultaneous damage to other organs No opiate addiction
Exclusion criteria:
The researcher is not able to intervene during the procedure according to the patient's condition.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 276
Randomization (investigator's opinion)
Randomized
Randomization description
In order to assign the samples to two groups, stratified random block method will be used. The randomization unit will be individual and in blocks of 4 people. The selection of the group type for each person will be done through the random allocation 2 software. To construct a block of 4, gender and tear length variables will be matched (classified) (for example, all 4 men with approximately the same tear length will be placed in the same block). Next, in each block, according to the arrival of patients, they will receive numbers 1 to 4, and according to the A and B codes generated by the software, allocation will be done. Code A means applying the intervention group and code B means applying the control group for each person. The codes will be placed in the sealed envelope and the number of each patient will be written on the envelope.
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square. , Sari, mazandaran, Iran.
City
sari
Province
Mazandaran
Postal code
4816715793
Approval date
2024-06-01, 1403/03/12
Ethics committee reference number
IR.MAZUMS.REC.1403.097

Health conditions studied

1

Description of health condition studied
Wound healing
ICD-10 code
Y74.3
ICD-10 code description
Surgical instruments, materials and general hospital and personal-use devices (including sutures) associated with adverse incidents

Primary outcomes

1

Description
pain
Timepoint
For the intervention group and the control group, pain will be measured once after being placed on the bed and the second time after the completion of the suture
Method of measurement
Visual Analogue Scale

2

Description
Anxiety disorders
Timepoint
For the intervention and control groups, anxiety will be measured once after being placed on the bed and the second time after the completion of the suture
Method of measurement
facial anxiety scale

3

Description
Satisfaction with service delivery
Timepoint
For the intervention group and the control group, the pulse rate will be measured once after being placed on the bed and the second time after the suture is finished
Method of measurement
Measure the number of pulses per minute

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the music group, after placing the patient on the bed, anxiety and pain are measured, and then traditional Iranian wordless music, Pik Sahari, composed by master Homayoun Khorram and played by Babak Shahraki, is played for the patient with the help of JBL speakers. is playedThe performance of this song is a trio with a centaur, violin and tambak, and its duration is 1 minute and 54 seconds, and this song is recorded consecutively for 45 minutes so that there is no gap in its playback during the healing of the wound and until the healing is complete. to be continued.Its sedation was determined by the MT30 device at the rate of 76 beats. Considering that the beat is between 60 and 80, this music is soothing (32) and it is played with a JBL speaker and the volume is adjusted by the patient. The duration of music playback is recorded for each patient separately. Wound washing and anesthetic injection are performed. It should be noted that the maximum safe dose of lignocaine (lidocaine) for local anesthesia for wound healing is 3 mg/kg (33). which will be recorded in each patient. The suture is applied by the intern or the nurse, and after the suture is finished in the test group, the music is stopped and the pulse rate, satisfaction, pain and anxiety are measured again.
Category
Treatment - Devices

2

Description
Control group: In the control group, after placing the patient on the bed, the pulse rate, anxiety and pain are measured. Wound washing and anesthesia injection will be performed and the amount of anesthesia injection will be recorded. After finishing the stitches in the control group, the level of satisfaction, pulse rate, pain and anxiety will be measured again.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
معصومه باقری نسامی
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moalem street, Moalem square, Sari, Mazandaran, Iran
City
sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3336 1985
Email
anna3043@gmail

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
دکتر مجید سعیدی
Street address
Mazandaran University of Medical Sciences,Valiye asar highway , joybar 3 way ,Imam sq
City
sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3397 8055
Email
anna3043@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Mazandaran Mideacal Science
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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
anna3043@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
phd in nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
sari,joybar three ways,mazandaran university of medical scinces
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3379 5508
Email
ann3043@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoumeh Bagheri Nesami
Position
PhD in Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
City
sari
Province
Mazandaran
Postal code
4816715793
Phone
+98 11 3336 7551
Email
Anna3043@gmail.com

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
There is no further information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
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