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

NCT06012877 | Completed

• 1 other identifier: UPNA-Health_Friendly
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Fear

Keywords

Medical Fear; Children; Health Education; Simulated Healthcare Spaces

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

Intervention Group

EXPERIMENTAL

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).

Behavioral: Health Friendly Program

Control group

NO INTERVENTION

Participants in this group continued with normal activities at school and at home, just like the intervention group, so that the only difference between the two groups was taking part in the intervention. Once the post-study data had been collected from all participants, the participant in the control group also took part in the intervention, a few days later.

Interventions

Health Friendly Program BEHAVIORAL

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).

Intervention Group

Eligibility Criteria

• Age: 5 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• N/A

Sponsors & Collaborators

• Fundacion Miguel Servet: lead
• Universidad Pública de Navarra: collaborator

Study Sites (1)

Public University of Navarre

Pamplona, Navarre, 31008, Spain

Location

Related 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.

  PMID: 35010711 BACKGROUND

MeSH Terms

Conditions

Health Education

Condition Hierarchy (Ancestors)

Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Leticia Martín-Rodríguez, PhD

  Universidad Pública de Navarra

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 28, 2023
• Study Start: September 15, 2019
• Primary Completion: April 15, 2020
• Study Completion: May 15, 2020
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)