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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05398146
Other study ID # 2018.5.07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date February 1, 2020

Study information

Verified date May 2022
Source Okan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date February 1, 2020
Est. primary completion date February 1, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility 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 (36.5-37.2°C), - 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 Design


Related Conditions & MeSH terms


Intervention

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.
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.
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.

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (2)

Lead Sponsor Collaborator
Melike Yilmaz Akdag Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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