- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392022
The Effect of Having a Child Watch Musical Cartoons
April 26, 2024 updated by: aysel kokcudogan
The Effect of Having a Child Watch Musical Cartoons on Anxiety and Vital Signs During Rectal Irrigation
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Beykoz
-
Istanbul, Beykoz, Turkey, 34083
- Aysel Kokcu Dogan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
Children in this group were shown musical cartoons during rectal irrigation.
|
The purpose of this study was to evaluate the effect of watching musical cartoons on anxiety and vital signs in children undergoing rectal irrigation.
|
|
No Intervention: Control group
No additional intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Child Anxiety Scale-Stateness,
Time Frame: 10 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Vital signs evaluation
Time Frame: 10 minutes
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Aysel Kokcu Dogan, Medipol University
- Principal Investigator: Buse Tugcuoglu, Medipol University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 13, 2021
Primary Completion (Actual)
May 25, 2022
Study Completion (Actual)
July 25, 2022
Study Registration Dates
First Submitted
April 20, 2024
First Submitted That Met QC Criteria
April 26, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 26, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- E-10840098-772.02-6325
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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