The effect of music therapy on the pain of 3- to 6-year-old children undergoing suture wound healing and their parents' anxiety in the emergency department.
Determining the effect of music therapy on the pain of children aged 3 to 6 years under wound healing by stitching and their parents' anxiety in the emergency department.
Design
The present study is a random clinical trial of parallel witnesses, with qualified patients divided into two groups of 60 intervention and control.
Settings and conduct
In the present study, Iranian childish music is played in the outpatient operating room with respect to the age of children 3 to 6 years. . Children's pain and parental anxiety with the scales of pain on the face of Wong Baker and the short -sighted Spyberger positioning questionnaire are measured before the wound washing, and immediately after lidocaine injection. Finally, at the end of the suture and before the patient discharged, the amount of child's pain and anxiety is measured and the music is cut off. The study site is the emergency department of Valiasr Hospital in Ghaemshahr.
Participants/Inclusion and exclusion criteria
Entry Criterion: Rupture in the face area less than 3 cm requires suture. Having age 6-3 years,
Mental disability, vision, hearing, speech, physical -motor and palsy. Pain analgesics and the child has not taken painkillers before suture. Parents are next to the child. Not having a child with neuromacular diseases. Lack of sensory disorders in the child. No need for sutures around the eyes. Simultaneously to other organs. Lack of child parenting with neurological and mental illnesses.
Intervention groups
Intervention Group: The music player broadcasts with a mobile phone from the time of the child in the outpatient operating room until the end of the procedure and clearance. Control Group: Children will be sutured as usual and music will not be played for them.
Main outcome variables
The emount of pain and anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110906007494N43
Registration date:2022-10-24, 1401/08/02
Registration timing:registered_while_recruiting
Last update:2022-10-24, 1401/08/02
Update count:0
Registration date
2022-10-24, 1401/08/02
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
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-05-21, 1402/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of music therapy on the pain of 3- to 6-year-old children undergoing suture wound healing and their parents' anxiety in the emergency department.
Public title
The effect of music therapy on the pain of children and their parents' anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in the study.
A tear of 3 cm or less in the face that requires sutures.
Having an age of 3 to 6 years.
Presence of parents with the child
Exclusion criteria:
The child and the family do not cooperate for any reason while interfering.
The researcher is not able to intervene during the child's status according to the condition of the child, that is, if the child is restless and the parents become stressed and symptoms of agitated for the child's music during the study.
Mental disability, vision, hearing, speech, physical -motor and organ paralysis.
Ruptures that need sedation.
Baby with neurological and mental illnesses treated.
Baby with diabetes.
Ruptures that need analgesic and the baby has not taken painkillers before suture.
Child with neuromacular disease.
Sensory disorders in children.
Parents of the child with psychiatric diseases treated.
No need to suture around the eye.
Absence of multiple ruptures and simultaneous damage to other organs.
Age
From 3 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
The blocking method will be used to randomly allocate samples which is the tool for generating block random sequence, random allocation software 2. It should be noted that in the random assignment process only subgroup will be considered and the age of children only includes the age range of 3 to 6 years. Depending on the sample size, 30 four blocks will be considered, which are inside each block 2 girls and 2 boys, and one girl and one boy will be in each test and control groups. Children will also be matched by parents (parents). For this purpose, there are 20 blocks for the mobile mother (80 mothers and children in each group 40 mothers and children) and 10 blocks for mobile fathers (40 fathers and children in each group of 20 parents) will be. The envelopes are hidden so that the cards are designed in the form of a block classification from 1 to 120 and are placed inside the envelope. The envelopes are not transparent and their doors are sealed, so random hiding is done.
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
Moalem Square, University Building No. 2, Research Vice-Chancellor of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4816715793
Approval date
2022-10-08, 1401/07/16
Ethics committee reference number
IR.MAZUMS.REC.1401.340
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
The pain measurement of children in the intervention and control groups is done before washing the wound, immediately after the injection of lidocaine and the end of the suture.
Method of measurement
Pain scale from Wong Baker's face
Secondary outcomes
1
Description
anxiety
Timepoint
Parental anxiety control is done before washing the wound and after finishing the suture in children of the intervention and control groups.
Intervention group: In the intervention group, immediately after the presence of the children in the ambulatory operating room, Iranian children's wordless music called Badbadek, composed by Mr. Amir Hossein Sargazi, is played in the ambulatory operating room. to be The performance of this song is multi-instrumental and includes guitar, bass, drums, string group (violins) and bells, and its duration is 3 minutes and 19 seconds. This song is recorded continuously for 15 minutes until there is a gap in the playback. It does not happen during wound healing and continues until the end of healing. Its sedation was determined by the MT30 device at the rate of 78 beats. Considering that the beat is between 60 and 80, this music is soothing and is played using a Xiaomi mobile phone in the ambulatory operating room at a distance of one meter from the child's head. Children's pain and parents' anxiety are measured with Wongbaker's facial pain scale and Spielberger's shortened situational anxiety questionnaire before washing the wound, immediately after lidocaine injection, children's pain is measured. Finally, at the end of the suture and before the patient's discharge, the amount of children's pain and parents' anxiety is measured and the music is stopped.
Category
Treatment - Devices
2
Description
Control group: In the control group, the children were stitched according to the usual routine and no music was played for them, after placing the patient on the bed and before washing the wound, the children's pain level and the parents' anxiety were measured, immediately after lidocaine injection, the children's pain level in The control group is measured. Finally, after the suture is finished, the amount of children's pain and parents' anxiety is measured.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Valiasr Hospital
Full name of responsible person
Masoumeh Bakhshandeh
Street address
Sari Street, Valiasr Hospital
City
Ghaemshahr
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 4203 2032
Email
bakhshandehm700@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Moalem St
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3397 8055
Email
bakhshandehm700@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Masoume Bagheri Nasami
Position
PhD in nursing education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Khazar Square, Research Center of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3379 5508
Email
bakhshandehm700@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
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
Fax
Email
Anna3043@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
Fax
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