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

Sponsor

Melike Yilmaz Akdag (Other)

Overall Status

Completed

CT.gov ID

NCT05398146

Collaborator

Kanuni Sultan Suleyman Training and Research Hospital (Other)

Enrollment

Location

Arms

Actual Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Behavioral: mathematical operations Behavioral: ball squeezing Behavioral: listening to music Other: kontrol grubu	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Feb 1, 2020

Actual Study Completion Date :

Feb 1, 2020

Arms and Interventions

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.

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

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

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa	Istanbul		Turkey

Sponsors and Collaborators

Melike Yilmaz Akdag
Kanuni Sultan Suleyman Training and Research Hospital

Investigators

Principal Investigator: birsen mutlu, Istanbul University-Cerrahpasa

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Melike Yilmaz Akdag, Principal Investigator, RN, MSc, Okan University

ClinicalTrials.gov Identifier:

NCT05398146

Other Study ID Numbers:

2018.5.07

First Posted:

May 31, 2022

Last Update Posted:

May 31, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Melike Yilmaz Akdag, Principal Investigator, RN, MSc, Okan University

Study Results

No Results Posted as of May 31, 2022