- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07430995
Comparing Storybooks and Hand Puppets to Reduce Fear in Children Undergoing Day Surgery
The Effect of Two Different Distraction Methods Applied Before Day Case Surgery on Children's Fear and Emotional Indicators: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Province
-
Muş, Province, Turkey (Türkiye), 49000
- Mus State Hospital, Pediatric Surgery Department
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Storybook Group
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.
|
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.
|
|
Experimental: Hand Puppet Group
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.
|
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.
|
|
Placebo Comparator: Control Group
Participants in this group received only the standard preoperative nursing care provided by the hospital, with no additional distraction methods.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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"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
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.
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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).
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13.11.2024-167632
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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