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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06392022
Other study ID # E-10840098-772.02-6325
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 13, 2021
Est. completion date July 25, 2022

Study information

Verified date April 2024
Source Istanbul Medipol University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation. This study was a randomized controlled experimental trial. The study sample consisted of 40 children, 20 of whom were assigned to the experimental group and 20 to the control group. Data Collection Form, Vital Signs Evaluation Form, and Child Anxiety Scale-Stateness were used as data collection tools. Data collection tools were used in both groups before, during, and after the procedure. In addition, the experimental group was shown musical cartoons during the procedure.


Description:

The present study was conducted as a randomized controlled experimental study to investigate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation. Does watching musical cartoons during rectal irrigation have an effect on children anxiety and vital signs? The answer to the question has been sought.The study sample consisted of 40 children aged 4-10 years who met the inclusion criteria and whose parents provided written and verbal consent for their participation in the study after being informed at the Pediatric Surgery and Pediatric Urology Department of a public hospital affiliated to the Provincial Health Directorate of the Ministry of Health in Istanbul. Because of the high power requirement and the potential for loss to follow-up, the study was conducted with a total of 40 children, 20 assigned to the experimental group and 20 to the control group, who met the eligibility criteria and consented to participate. The children were randomly assigned to the control or experimental group. Children enrolled in the study were assigned to the experimental or control group using the https://www.calculatorsoup.com. Data Collection Form, Child Anxiety Scale-Stateness, and Vital Signs Evaluation Form were used as data collection tools.After obtaining institutional approval and written consent from parents after informing them and their children, data were collected by the investigators through a face-to-face interview that took approximately 11-20 minutes per child. The intervention to be applied to the experimental group was carried out by the investigator after informing the children and parents and obtaining their written consent.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 25, 2022
Est. primary completion date May 25, 2022
Accepts healthy volunteers No
Gender All
Age group 4 Years to 10 Years
Eligibility Inclusion Criteria: - Children aged 4-10 years - Children who can count from one (1) to ten (10). - Children who love cartoons with music. Exclusion Criteria: - Children without visual or hearing impairments - Children without mental problems

Study Design


Related Conditions & MeSH terms


Intervention

Other:
watching cartoons with music
The purpose of this study was to evaluate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation.

Locations

Country Name City State
Turkey Aysel Kokcu Dogan Istanbul Beykoz

Sponsors (1)

Lead Sponsor Collaborator
aysel kokcudogan

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Child Anxiety Scale-Stateness, Child anxiety-state scale: Measures the anxiety state of children between the ages of 4-10.
The level of anxiety increases as the scale rating progresses up to the top point.
10 minutes
Secondary Vital signs evaluation This form was developed by the investigators to record patients' vital signs (blood pressure, pulse rate, respiratory rate, body temperature) before, during, and after the procedure. 10 minutes
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