Evaluation of the "Health Friendly" Program to Reduce Children's Fear of the Healthcare Environment.

Not Applicable

Completed

• Conditions: Fear

• Registration Number: NCT06012877
• Lead Sponsor: Fundacion Miguel Servet

Brief Summary

The goal of this clinical trial is to evaluate the effectiveness of a novel intervention that involved contact interaction with a simulated healthcare space to reduce medical fear in children in infant class. The main question it aims to answer is: • Will the Health Friendly Program, based on the interaction with a simulate healthcare space, reduce medica fear among children in infant class? Participants will participate in the Health Friendly Program that will consist of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions. Researchers will compare two groups (intervention group and control group) to see if there exist differences between both groups in their responses to the Child Medical Fear Scale.

Detailed Description

Purpose: This study aimed to evaluate the effectiveness of a novel intervention that involved contact interaction with a simulated healthcare space to reduce medical fear among children in infant class.

Methods: This was an experimental study involving 86 children divided into an intervention group and a control group with pre and post measurements. The intervention, known as the Health-Friendly Programme, consisted of showing children various scenarios that simulated different medical contexts so that they were able to get involved in them, experiment with the materials and ask questions. Medical fear was evaluated using the Spanish version of the revised version of the "Child Medical Fear Scale", which scored fear between 0 and 34 points. The pre-test and post-test levels of medical fear in the intervention and control groups were compared with the Student's t test.

Study Timeline

• Study Start: 2019-09-15
• Primary Completion: 2020-04-15
• Study Completion: 2020-05-15
• Status Verified: 2023-08
• Study First Submitted: 2023-08-02
• Study First Submitted QC: 2023-08-24
• Last Update Submitted: 2023-08-24
• Study First Posted: 2023-08-28
• Last Update Posted: 2023-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 128

Inclusion Criteria

• Boys and Girls from the third year of Preschool Education (6 years old) at two schools from a town in the North of Spain (school A and B) enrolled in the study.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Medical fear	From the participation in the intervention to one week later.	Medical fear was measured using the revised version of the "Child Medical Fear Scale" (CMFS-R), in its validated Spanish version. The scale has 17 items with statements on fear of certain aspects related to the healthcare environment, that the children answer according to a three-point scale (0 = no fear, 1 = some fear and 2 = very frightened). The maximum total score on the scale is 34 points. The Spanish validation confirmed the existence of the 4 dimensions identified in the original CMFS-R scale: intrapersonal, procedural, environmental and interpersonal fears

Trial Locations

Locations (1)

Public University of Navarre; 🇪🇸 Pamplona, Navarra, Spain