The Effect of Three Methods Used in Reducing Pain During Dressing Change

The Effect of Listening to Music, Performing Mathematics Operations and Ball Squeezing in Reducing Pain During Dressing Change in Children With Appendectomy

This randomized controlled study aims to determine the effect of listening to music (LM), ball squeezing (BS), and performing mathematical operations (MO) in reducing the pain experienced during the first dressing in children aged 8-18 with appendectomy.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Behavioral: mathematical operations; Behavioral: ball squeezing; Behavioral: listening to music; Other: kontrol grubu

Detailed Description

The sample of the study consisted of 120 children (LM:30, BS:30, MO:30, control:30). A minute before dressing and during dressing, the children in the LM group listened to music, the children in the SB group squeezed the ball, the children in the MO group performed mathematical operations.According to the child, parent, and nurse assessment, it was determined that the mean pain score of the children in the LM and MO groups was lower than that of the BS group and control groups (p< .05).

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey
    • Istanbul University-Cerrahpasa

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consisted of the child and parent's consent to participate in the study,
• The child and parent's speaking Turkish at the level of native speaker,
• The child's being 8-18 years old and undergoing appendectomy,
• Being the body temperature of the child in the normal level (36.5-37.2⁰C),
• The child's not having intense nausea and vomiting,
• The child's not having any physical, intellectual or neurological disability that would affect his/her participation.

Exclusion Criteria:

• Having a mental or neurological disability
• Children with hearing and vision impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pre-Dressing; Information about the children and their parents who agreed to participate in the study was recorded on the 'Information Form' 5 minutes before the dressing procedure by the researcher.	Behavioral: mathematical operations; Prepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels.; Behavioral: ball squeezing; For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.; Behavioral: listening to music; Children were allowed to listen to music with headphones during dressing changes.; Other: kontrol grubu; No application was made during dressing change in children. Routine dressing change of the clinic was applied.
EXPERIMENTAL: During Dressing; The first dressing of all children included in the study after appendectomy was performed by the doctor in the clinic. No distraction method was applied to the children in the control group during dressing. The children in the LM group were dressed while listening to music. The children in the BS group continued to squeeze the ball during the dressing. The children in the MO group were asked to perform mathematical operations given by the nurse. While the dressing was in progress, the pulse and oxygen saturation levels were recorded in the information form by the nurse. At the last stage of dressing, the children were asked to mark the level of pain they experienced during dressing on the VAS, immediately after the sticking plaster was placed on the surgical area. Parents and nurses assessed the pain level of the child during dressing through the VAS.	Behavioral: mathematical operations; Prepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels.; Behavioral: ball squeezing; For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.; Behavioral: listening to music; Children were allowed to listen to music with headphones during dressing changes.; Other: kontrol grubu; No application was made during dressing change in children. Routine dressing change of the clinic was applied.
EXPERIMENTAL: Post-Dressing; When the dressing was over, the application of distraction methods was terminated. After the dressing, the child's pulse and oxygen saturation levels were recorded in the information form by the nurse.	Behavioral: mathematical operations; Prepared by the researchers, the form involved mathematical operations such as addition, subtraction, multiplication, and division. The difficulty level of the mathematical operations in the form was determined by age groups of children. Accordingly, mathematical operations were divided into 3 groups primary school, secondary school and high school levels.; Behavioral: ball squeezing; For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.; Behavioral: listening to music; Children were allowed to listen to music with headphones during dressing changes.; Other: kontrol grubu; No application was made during dressing change in children. Routine dressing change of the clinic was applied.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of Pain Scores pre-dressing	Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).	60 seconds
Comparison of Pain Scores During Dressing	Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).	60 seconds
Comparison of Pain Scores post-Dressing	Visual Analog Scale (VAS) was used for determine pain level in this research. Scale got 0 to 10 points (0 (Good) to 10 (Bad)).	60 seconds

Collaborators and Investigators

• Sponsor: Melike Yilmaz Akdag
• Collaborators: Kanuni Sultan Suleyman Training and Research Hospital
• Investigators: Principal Investigator: Birsen Mutlu, Istanbul University - Cerrahpasa (IUC)

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2019
• Primary Completion (ACTUAL): February 1, 2020
• Study Completion (ACTUAL): February 1, 2020

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (ACTUAL): May 31, 2022

Study Record Updates

• Last Update Posted (ACTUAL): May 31, 2022
• Last Update Submitted That Met QC Criteria: May 25, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: pain; child; dressing; distraction; appendectomy
• Other Study ID Numbers: 2018.5.07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No