Skip to main content
OpenTrials
Completed

NCT Number: NCT07430995

Comparing Storybooks and Hand Puppets to Reduce Fear in Children Undergoing Day Surgery

Summary The aim of this study is to see if storybooks or hand puppets help reduce fear in children before outpatient surgery. Researchers want to find out which of these two methods works better to help children feel calmer and less upset.

Why is this study being conducted? Going into surgery can be frightening for children. This research is looking for simple and fun ways to reduce a child's fear without using medication.

How will the research be conducted?

The study included 99 children (ages 4-7) undergoing outpatient surgery. The children were divided into three equal groups:

Group 1 (Control): Received standard hospital care.

Group 2 (Storybook): Read an educational book about a character going into surgery.

Group 3 (Puppet): Played with a hand puppet before the procedure.

Researchers measured the children's fear and emotional responses twice: approximately 1 hour before surgery and immediately before entering the operating room. By comparing these scores, the study shows whether it was the storybook or the puppet that helped the children feel better.

Completed

Looking for future studies?

Notify Me

Key information

Age range

4 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mus State Hospital, Pediatric Surgery Department

Muş, Province, 49000, Turkey (Türkiye)

About this study

The aim of this randomized controlled trial is to evaluate and compare the effectiveness of two different non-pharmacological distraction methods-educational storybooks and hand puppets-on preoperative fear and emotional manifestations in children undergoing day case surgery.

Methodology:

The study was conducted with 99 children, aged 4 to 7, who met the inclusion criteria. Participants were randomly assigned to one of three groups using a 1:1:1 allocation ratio:

Control Group (n=33): Received standard preoperative nursing care, including routine information provided by the hospital staff.

Storybook Group (n=33): In addition to standard care, children were read an educational storybook titled "Elif Ameliyat Oluyor" (Elif is Having Surgery). The book describes the surgical process through a child's perspective to familiarize them with the environment.

Hand Puppet Group (n=33): In addition to standard care, a researcher engaged the child in interactive play using a hand puppet. The puppet was used to simulate the medical procedures in a non-threatening and playful manner.

Data Collection and Outcome Measures:

Two primary tools were used to collect data:

Child Fear Scale (CFS): A self-report scale used to assess the child's level of fear.

Children's Emotional Manifestation Scale (CEMS): An observational scale used by researchers to record behaviors such as crying, facial expressions, and cooperation.

Data were collected at two specific time points:

T1 (Baseline): Approximately 1 hour before the surgical procedure (pre-intervention).

T2 (Final): Immediately before the child was transferred to the operating room (post-intervention).

The study seeks to determine whether these distraction techniques significantly lower fear scores compared to standard care and which method is more effective in a clinical setting.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged between 4 and 7 years.
  • Children hospitalized in the pediatric surgery ward.
  • Scheduled for elective (planned) surgery.
  • Ability to understand and speak Turkish.
  • Willingness of both the child and a parent/legal guardian to participate in the study.

Exclusion criteria

  • Children with long-term hospitalization history.
  • Participants who received analgesic or sedative medication within the last 24 hours.
  • Presence of major trauma, chronic disease, or chronic pain conditions requiring rapid assessment.
  • Any physical or cognitive impairment that hinders effective communication (e.g., significant visual, hearing, or speech impairments).
  • Presence of diagnosed mental or developmental disabilities.
  • History of psychiatric disorders such as Attention Deficit Hyperactivity Disorder (ADHD).
  • Participants or parents who wish to withdraw from the study at any stage.

Treatment and study plan

Storybook Group

Behavioral

Participants completed an information form immediately after being admitted to the clinic in the morning. Then, a researcher read an educational storybook titled "Elif is Having Surgery." The intervention aimed to focus the child's attention on the surgical process through storytelling. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same story was read to the group again.

Hand Puppet Group

Behavioral

Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, a researcher used gender-specific felt hand puppets to help children integrate into the hospital environment, facilitate their adaptation to preoperative preparation, and reduce preoperative fear and negative emotional indicators. A form to measure fear and emotional indicators was then administered. One hour later, before the patient donned their surgical gown and left the room for surgery, the same puppet procedure was repeated for this group.

Control Group

Other

Participants completed an introductory information form immediately after being admitted to the clinic in the morning. Then, clinic nurses provided information about the routine procedure to prepare them for the operation. Following this, a form was administered to measure fear and emotional indicators. One hour later, before the patient donned the surgical gown and left the room for surgery, the same procedure was repeated to this group.

Primary outcomes

  1. Child Fear Scale (CFS) Score

    Time frame: "Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room)."

    The CFS is a self-report scale consisting of five faces ranging from a neutral expression (0 - no fear) to a frightened expression (4 - extreme fear). It is used to measure the child's subjective level of fear.

  2. Children's Emotional Manifestation Scale (CEMS) Score

    Time frame: Baseline (immediately upon hospital admission, approximately 1 hour before surgery) and pre-operative phase (approximately 60 minutes after the first measurement, just before transfer to the operating room).

    An observational scale consisting of 5 categories (facial expression, vocalization, activity, interaction, and cooperation). Each category is scored from 1 to 5, with total scores ranging from 5 to 25. Higher scores indicate higher emotional distress.

Sponsors and collaborators

Lead sponsor

Muş Alparslan University

Other

Registry information

Official study title

The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 24, 2026
Registry last updated
Feb 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.