NCT07414628

Brief Summary

This randomized controlled study aims to evaluate the effect of a drama-based coloring storybook on children's fear, anxiety, and pain management during the perioperative process. The study will be conducted with children aged 6-9 years who are scheduled for elective surgery. Participants will be randomly assigned to either an intervention group receiving the drama-based coloring storybook or a control group receiving routine preoperative care. Levels of fear, anxiety, and pain will be assessed using validated measurement tools at predefined perioperative time points. The findings are expected to contribute to evidence-based, child-centered perioperative care practices.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Feb 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress31%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

11 months

First QC Date

January 22, 2026

Last Update Submit

February 12, 2026

Conditions

Keywords

DramaStorybookPediatricPainAnxiety

Outcome Measures

Primary Outcomes (3)

  • Preoperative Anxiety Level in Children

    Preoperative anxiety will be assessed using the Modified Yale Preoperative Anxiety Scale - Short Form (mYPAS-SF), a validated observational scale consisting of 22 items across five domains: activity, speech, emotional expressivity, state of arousal, and interaction with family members. Total scores range from 23.33 to 100, with higher scores indicating greater anxiety.

    One hour before surgery and 10 minutes before surgery (prior to anesthesia induction)

  • Fear Level in Children

    Fear levels will be assessed using the Children's Fear Scale (CFS), a validated self-report scale for children. The scale consists of five facial expressions scored from 0 to 4, with higher scores indicating greater fear.

    One hour before surgery, 10 minutes before surgery (prior to anesthesia induction), and one hour after surgery

  • Postoperative Pain Level in Children

    Postoperative pain will be assessed using the Wong-Baker FACES Pain Rating Scale, a validated self-report pain scale for children. The scale ranges from 0 to 5, where 0 indicates no pain and 5 indicates the worst pain. Higher scores indicate greater pain intensity

    One hour after surgery

Study Arms (2)

Drama-Based Coloring Storybook Group

EXPERIMENTAL

Participants in this group receive a drama-based coloring storybook before surgery. The storybook is designed to prepare children for the perioperative process and to reduce fear, anxiety, and perceived pain through age-appropriate narratives and coloring activities.

Behavioral: Drama-Based Coloring Storybook Intervention

Control Group (Routine Care)

NO INTERVENTION

Participants in this group receive routine preoperative care according to hospital protocols, without exposure to the drama-based coloring storybook.

Interventions

Children aged 6-9 years in the experimental group receive a drama-based coloring storybook before surgery. The storybook, titled "Alican's Brave Journey," is designed to prepare children for the perioperative process through age-appropriate storytelling, coloring activities, and dramatic elements. The intervention is administered once during the preoperative period under the supervision of the researcher and aims to reduce preoperative fear, anxiety, and perceived pain.

Drama-Based Coloring Storybook Group

Eligibility Criteria

Age6 Years - 9 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsOnly male children aged 6-9 years who are scheduled for circumcision are eligible to participate in the study.
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 6-9 years.
  • Children scheduled for surgery due to circumcision.
  • Children who have not undergone previous surgery.
  • Children without vision, hearing, or speech problems.

You may not qualify if:

  • Children who have undergone previous surgery.
  • Children with vision, hearing, or speech problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Central Study Contacts

Yusuf B Budak, PhD Student

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to group allocation in order to reduce expectation bias. Due to the nature of the intervention, the care provider and the investigator were aware of the assigned groups. Outcome assessments were conducted using standardized self-report scales completed by the participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group receiving a drama-based coloring storybook or a control group receiving routine preoperative care.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant, Department of Nursing

Study Record Dates

First Submitted

January 22, 2026

First Posted

February 17, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to protect the privacy and confidentiality of children participating in the study.