The Effect of a Drama-Based Coloring Storybook on Children's Fear, Anxiety, and Pain Management in the Perioperative Process: "Alican's Brave Journey"

February 12, 2026 updated by: Yusuf Budak, Bingol University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized controlled trial designed to examine the effectiveness of a drama-based coloring storybook intervention in reducing fear and anxiety and improving pain management in children during the perioperative process. The study population consists of children aged 6-9 years undergoing elective surgical procedures. Participants will be randomly allocated to either an intervention group or a control group.

Children in the intervention group will receive a drama-based coloring storybook titled "Alican's Brave Journey", which introduces the perioperative process through age-appropriate language, illustrations, and interactive coloring activities. The storybook will be administered in the preoperative period by the researcher. The control group will receive routine preoperative care provided by the hospital. Children's fear, anxiety, and pain levels will be measured using validated assessment tools at preoperative and postoperative stages. The study aims to provide evidence on the effectiveness of drama-based educational materials in pediatric perioperative care.

Study Type

Interventional

Enrollment (Estimated)

72

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 Contact

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

Exclusion Criteria:

  • Children who have undergone previous surgery.
  • Children with vision, hearing, or speech 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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drama-Based Coloring Storybook Group
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
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.
No Intervention: Control Group (Routine Care)
Participants in this group receive routine preoperative care according to hospital protocols, without exposure to the drama-based coloring storybook.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preoperative Anxiety Level in Children
Time Frame: One hour before surgery and 10 minutes before surgery (prior to anesthesia induction)
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
Time Frame: One hour before surgery, 10 minutes before surgery (prior to anesthesia induction), and one hour after surgery
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
Time Frame: One hour after surgery
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bingol University

Collaborators

Ataturk 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 (Estimated)

February 1, 2026

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 17, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E-33117789-044-163219

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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

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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