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Clinical Trials/NCT06012877
NCT06012877CompletedNot Applicable

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

Fundacion Miguel Servet2 sites in 1 country128 target enrollmentStarted: September 15, 2019Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
128
Locations
2
Primary Endpoint
Medical fear

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential
Primary Purpose
Other
Masking
Triple (Participant, Care Provider, Investigator)

Eligibility Criteria

Ages
5 Years to 6 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

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

  • Not provided

Outcomes

Primary Outcomes

Medical fear

Time Frame: 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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fundacion Miguel Servet
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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