Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07430995
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.
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:
NCT07430995
Study Brief:
Protocol Section:
NCT07430995