FearHFriendlyNCT06012877
Evaluation of the "Health Friendly" Program to Reduce Children's Fear of the Healthcare Environment.
A study testing Health Friendly Program in people with Fear, run by Fundacion Miguel Servet at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 5 to 6 yearsHealthy volunteers can take part
- Conditions the study is for
- Fear
- What is being tested?
- Health Friendly Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2019to 15 May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 6 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Fear
- Being tested
- Health Friendly Program
- Keywords
- Medical Fear, Children, Health Education, Simulated Healthcare Spaces
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Friendly ProgramBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From the participation in the intervention to one week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2023
- Study start15 Sep 2019
- Primary completion15 Apr 2020
- Study completion15 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Responsible party
- Sponsor
- Investigators
- Leticia Martín-Rodríguez, PhD, Principal investigator, Universidad Pública de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06012877
- Sponsor's protocol ID
- UPNA-Health_Friendly
- Acronym
- HFriendly
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 28 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35010711
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the "Health Friendly" Program to Reduce Children's Fear of the Healthcare Environment.
- ClinicalTrials.gov ID
- NCT06012877
- Acronym / sponsor ID
- HFriendly / UPNA-Health_Friendly
- Conditions
- Fear
- Keywords
- Medical Fear, Children, Health Education, Simulated Healthcare Spaces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Universidad Pública de Navarra
- Study start
- 15 Sep 2019 (actual)
- Primary completion
- 15 Apr 2020 (actual)
- Study completion
- 15 May 2020 (actual)
- First posted
- 28 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Cluster randomized controlled trial with an intervention group (IG) and a control group (CG) with pre- and post-measurements
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Health Friendly ProgramThe 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). |
| 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. |
Who may qualify
- Ages
- 5 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Friendly ProgramThe 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). | Behavioural | Intervention Group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2023.
- Background: PubMed 35010711San 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leticia Martín-Rodríguez, PhD principal investigator
Universidad Pública de Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Friendly Program in people with Fear, run by Fundacion Miguel Servet at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medical fear (time frame: From the participation in the intervention to one week later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06012877, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2023.