NCT06361069

Brief Summary

Aim: This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery. Methods: The study was conducted using the "pre-post test unmatched group model", one of the quasi-experimental methods. The study was conducted between April 2023 and January 2024 with children aged 6-12 years who were admitted to the pediatric clinic of a hospital for day surgery. A total of 85 children (including 20 children in the control group, 22 children in the finger puppet intervention group, 21 children in the distraction cards intervention group, and 22 children in the kaleidoscope intervention group) who were hospitalized in the pediatric clinic between April 2023 and January 2024 and who met the inclusion criteria were included in the study. Descriptive statistics, Mann Whitney U test, Kruskal Wallis and regression analysis were used in the evaluation of the data.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Apr 2023

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

April 1, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
Last Updated

April 11, 2024

Status Verified

April 1, 2024

Enrollment Period

4 months

First QC Date

April 3, 2024

Last Update Submit

April 7, 2024

Conditions

Keywords

AnxietyChildDay surgery

Outcome Measures

Primary Outcomes (1)

  • Anxiety

    This study was conducted to determine the efficacy of finger puppets, distraction cards and kaleidoscope for reducing anxiety in children undergoing day surgery

    up to 10 months

Study Arms (2)

Control group

NO INTERVENTION

20 children in the control group

Experimental group

EXPERIMENTAL

22 in the finger puppet, 21 in the distraction cards intervention group, and 22 in the kaleidoscope intervention group

Other: distraction cards, kaleidoscope and finger puppet

Interventions

A kaleidoscope, characterized by vibrant patterns visible through rotation of its cylinders, operates on the principle of light refraction, producing dynamic and ever-changing visual displays. Distraction cards feature an array of images and shapes, each measuring approximately 5-8 cm in length. These intricate designs are discernible only upon careful examination of the cards. Puppets, as a therapeutic intervention tool, significantly influence children's personal, social, and emotional development, facilitating their comfortable expression of emotions.

Experimental group

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children aged 6-12 years
  • scheduled for day surgery
  • devoid of prior surgical experiences
  • willingly consented to participation.

You may not qualify if:

  • children undergoing major surgeries (e.g., cardiac procedures)
  • emergency surgical interventions
  • individuals with mental retardation
  • as well as those with visual or auditory impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bilecik Şeyh Edebali University

Bilecik, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • ASLI AKDENİZ KUDUBEŞ, phd

    BİLECİK ŞEYH EDEBALİ UNIVERSITY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The study was conducted using the "pre-post test unpaired group model", one of the quasi-experimental methods.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ASSOCIATE PROFESSOR

Study Record Dates

First Submitted

April 3, 2024

First Posted

April 11, 2024

Study Start

April 1, 2023

Primary Completion

August 1, 2023

Study Completion

January 1, 2024

Last Updated

April 11, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations