Clinical trial NCT06012877: Evaluation of the "Health Friendly" Program to Reduce Children's Fear of the Healthcare Environment.
Official title: Evaluation of the "Health Friendly" Program to Reduce Children's Fear of the Healthcare Environment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fear
Keywords: Medical Fear
Children
Health Education
Simulated Healthcare Spaces
Lead sponsor: Fundacion Miguel Servet
Sponsor class: OTHER
Collaborators: name: Universidad Pública de Navarra
First posted: 2023-08-28
Enrollment: 128
Sex: ALL
Minimum age (years): 5
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medical fear
timeFrame: From the participation in the intervention to one week later.
Secondary outcomes:
Other outcomes:
Locations:
city: Pamplona
country: Spain
facility: Public University of Navarre
state: Navarra
Study officials:
affiliation: Universidad Pública de Navarra
name: Leticia Martín-Rodríguez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: San Martin-Rodriguez L, Soto-Ruiz N, Ferraz-Torres M, Garcia-Vivar C, Saralegui-Gainza A, Escalada-Hernandez P. The Spanish Version of the Child Medical Fear Questionnaire: Cross-Cultural Adaptation and Validation. Int J Environ Res Public Health. 2021 Dec 31;19(1):451. doi: 10.3390/ijerph19010451.