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

Fear Clinical Trial

— HFriendly  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06012877
• Other study ID #: UPNA-Health_Friendly
• Status: Completed
• Phase: N/A
• Start date: September 15, 2019
• Est. completion date: May 15, 2020

Study information

• Verified date: August 2023
• Source: Fundacion Miguel Servet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: May 15, 2020
• Est. primary completion date: April 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Fear

Intervention

Behavioral:
• Health Friendly Program
The intervention, known as the Health-Friendly Programme, took place at the Clinical Skills and Simulation Centre of the Public University of Navarre. The intervention consisted of showing the children different scenarios that simulated various medical contexts, letting them experiment with the material and ask questions. The structure and content of the intervention were intended to address two main issues. First, the health contexts with which school-age children may come into contact with; these are a consultation at a health centre and a hospital room. Second, the concerns, in relation to intrapersonal, procedural, environmental and interpersonal aspects, experienced by children when they interact with health care professionals or they are sick. As reference material, the intervention is described in detail in the guide about the Health-Friendly Programme (Escalada-Hernández et al., 2021).

Locations

Country	Name	City	State
Spain	Public University of Navarre	Pamplona	Navarra

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion Miguel Servet	Universidad Pública de Navarra

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medical fear	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	From the participation in the intervention to one week later.