NCT06392022

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 25, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 20, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
Last Updated

April 30, 2024

Status Verified

April 1, 2024

Enrollment Period

5 months

First QC Date

April 20, 2024

Last Update Submit

April 26, 2024

Conditions

ChildCartoon

Keywords

Anxietychildmusical cartoonsvital signs

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Vital signs evaluation

    10 minutes

Study Arms (2)

Experimental group

EXPERIMENTAL

Children in this group were shown musical cartoons during rectal irrigation.

Other: watching cartoons with music

Control group

NO INTERVENTION

No additional intervention

Interventions

watching cartoons with musicOTHER

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

Experimental group

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 4-10 years
  • Children who can count from one (1) to ten (10).
  • Children who love cartoons with music.

You may not qualify if:

  • Children without visual or hearing impairments
  • Children without mental problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aysel Kokcu Dogan

Istanbul, Beykoz, 34083, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Aysel Kökcü Doğan

    Medipol University

    STUDY DIRECTOR

  • Buse Tugcuoglu

    Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

April 20, 2024

First Posted

April 30, 2024

Study Start

December 13, 2021

Primary Completion

May 25, 2022

Study Completion

July 25, 2022

Last Updated

April 30, 2024

Record last verified: 2024-04

Locations

TU(1)