Clinical trial NCT06392022: The Effect of Having a Child Watch Musical Cartoons
Official title: The Effect of Having a Child Watch Musical Cartoons on Anxiety and Vital Signs During Rectal Irrigation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child
Cartoon
Keywords: Anxiety
child
musical cartoons
vital signs
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Anxiety Scale-Stateness,
timeFrame: 10 minutes
Secondary outcomes:
measure: Vital signs evaluation
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Aysel Kokcu Dogan
state: Beykoz
Study officials:
affiliation: Medipol University
name: Aysel Kökcü Doğan
role: STUDY_DIRECTOR
affiliation: Medipol University
name: Buse Tugcuoglu
role: PRINCIPAL_INVESTIGATOR
References: