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IRCT20110906007494N43 IRCT 2022-10-24 Mazandaran University of Medical Sciences The effect of music therapy on the pain of children and their parents' anxiety 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. 2022-10-23 anticipated 120 Complete https://irct.ir/trial/65486 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Wound healing. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is No more information
public Dr. Masoume Bagheri Nasami
Khazar Square, Research Center of Mazandaran University of Medical Sciences
Sari Iran (Islamic Republic of) 4815733971 +98 11 3379 5508 bakhshandehm700@gmail.com Mazandaran University of Medical Sciences scientific Masoumeh Bagheri Nesami
Mazandaran University of Medical Sciences, Imam Square, Highway Bassij, 3-way Jouibar, Sari
Sari Iran (Islamic Republic of) 4816715793 +98 11 3336 7551 Anna3043@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) 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 3 years 6 years Both 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. Y74.3 Surgical instruments, materials and general hospital and personal-use devices (including sutures) associated with adverse incidents Treatment - Devices N/A 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. 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. 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. Anxiety. Timepoint: Parental anxiety control is done before washing the wound and after finishing the suture in children of the intervention and control groups. Method of measurement: Shortened Spielberger situational anxiety questionnaire. Mazandaran University of Medical Sciences Approved 2022-10-08 Ethics Committee of Mazandaran University of Medical Sciences Moalem Square, University Building No. 2, Research Vice-Chancellor of Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)