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

NCT07430995 | Completed

• 1 other identifier: 13.11.2024-167632
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Preoperative Fear; Emotional Distress

Keywords

Pediatric Surgery; Preoperative Fear; Distraction Techniques; Storytelling; Puppetry; Emotional Responses; Nursing Care

Outcome Measures

Primary Outcomes (2)

• Child Fear Scale (CFS) Score

  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.

  "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)."

• Children's Emotional Manifestation Scale (CEMS) Score

  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.

  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).

Study Arms (3)

Storybook Group

EXPERIMENTAL

Prior to the intervention, participants were read an educational storybook titled "Elif is Having Surgery" by a researcher. The intervention focused on introducing the child to the surgical process through storytelling.

Behavioral: Storybook Group

Hand Puppet Group

EXPERIMENTAL

Participants engaged in pre-intervention interactive play with a hand puppet under the guidance of a researcher. The puppet recorded the treatment process to simulate the treatment and provide emotional support through play.

Behavioral: Hand Puppet Group

Control Group

PLACEBO COMPARATOR

Participants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods.

Other: Control Group

Interventions

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.

Storybook Group

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.

Hand Puppet 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.

Control Group

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Muş Alparslan University: lead

Study Sites (1)

Mus State Hospital, Pediatric Surgery Department

Muş, Province, 49000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Surgical procedures were scheduled for wednesdays and fridays. Therefore, the research was conducted on wednesdays and fridays. Wednesday was puppet day and Thursday was storybook day. Consequently, "Due to the nature of the interventions (storybooks=33 and hand puppets=33), participants were completely blinded to the assigned group. However, the research practitioner was dominant in the process, and the nurse was blinded to the study's baseline hypotheses. Furthermore, during the statistical evaluation phase, the other researcher was blinded to group assignments to prevent bias and was not involved in the data collection process." After the experimental groups reached the desired number, control groups =33 were collected.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 24, 2026
• Study Start: January 1, 2025
• Primary Completion: June 20, 2025
• Study Completion: June 25, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TU (1)