NCT05398146

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

1.1 years

First QC Date

May 25, 2022

Last Update Submit

May 25, 2022

Conditions

Keywords

painappendectomychilddistractiondressing

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Pre-Dressing

EXPERIMENTAL

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 operationsBehavioral: ball squeezingBehavioral: listening to musicOther: kontrol grubu

During Dressing

EXPERIMENTAL

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 operationsBehavioral: ball squeezingBehavioral: listening to musicOther: kontrol grubu

Post-Dressing

EXPERIMENTAL

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 operationsBehavioral: ball squeezingBehavioral: listening to musicOther: kontrol grubu

Interventions

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.

During DressingPost-DressingPre-Dressing
ball squeezingBEHAVIORAL

For the children in the BS group, a softball that could fit in the palm and be easily squeezed by the child was used.

During DressingPost-DressingPre-Dressing

Children were allowed to listen to music with headphones during dressing changes.

During DressingPost-DressingPre-Dressing

No application was made during dressing change in children. Routine dressing change of the clinic was applied.

During DressingPost-DressingPre-Dressing

Eligibility Criteria

Age8 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • birsen mutlu

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator, RN, MSc

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

January 1, 2019

Primary Completion

February 1, 2020

Study Completion

February 1, 2020

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations