Back to resultsPilot Project of Forest Bathing for Promoting Health
Primary Purpose
Intellectual Disability
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Forest bathing
Sponsored by
About this trial
This is an interventional prevention trial for Intellectual Disability
Eligibility Criteria
Inclusion Criteria:
- Adults with intellectual disability enrolled in a specific occupational center.
- Being informed about the study and having signed the informed consent document.
Exclusion Criteria:
- Having stated their not willing to participate in the study
Sites / Locations
- Universidad de Navarra
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Forest bathing
Arm Description
Outcomes
Primary Outcome Measures
Systolic and diastolic blood pressure
Heart coherence
Using emWave Pro Plus device and software
Perceived quality of life and wellbeing
Using INICO-FEAPS questionnaire (Verdugo Alonso et al., 2013): Scale for the Integral Evaluation of the Quality of Life of people with intellectual or developmental disability, developed by the University Institute for Community Integration (INICO) and the Spanish Confederation of Organizations for People with Intellectual or Developmental Disability (FEAPS).
It is a self-report tool that consists of 72 four-point Likert-type items divided among 8 dimensions: self-determination, rights, emotional wellbeing, social inclusion, personal development, interpersonal relationships, material well-being, and physical well-being. Each dimension is composed of nine items. Each subscale score is calculated by summing up the score for each of the nine items, and a total score is then calculated by summing up the scale scores. Higher scores are associated to better quality of life.
Secondary Outcome Measures
Physiological Equivalent Temperature
Following Höppe (1999) procedure
Thermic perception
Using questionnaire published in previous studies (Teli et al., 2012; Trebilcock et al., 2017), that includes 3 items to assess thermal sensation vote (TMV) (7-point Likert scale), one item to assess thermal preference vote (TPV) (3-point scale), one item to assess the feeling of comfort (closed-answer), one item to get clothing information (closed-answer), and one item to evaluate the feeling of tiredness (3-point scale). The answers to these questions put the PET value (outcome 4) into context and help interpret it.
Barriers and facilitators
Field diary
Full Information
NCT ID
NCT05472571
First Posted
July 19, 2022
Last Updated
July 22, 2022
Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
La Caixa Foundation, Fundación Caja Navarra
1. Study Identification
Unique Protocol Identification Number
NCT05472571
Brief Title
Pilot Project of Forest Bathing for Promoting Health
Official Title
FOREST HEALTH: Pilot Project of Forest Bathing for Promoting Health, Human Wellbeing, and for Complementing Sustainable Management Forest and Landscape Practices
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
March 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinica Universidad de Navarra, Universidad de Navarra
Collaborators
La Caixa Foundation, Fundación Caja Navarra
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
An exploratory trial using a cuasi-experimental design aimed to improve the quality of life of people with intellectual disabilities. The intervention consists of 11 consecutive sessions of forest bathing (one session per week), each one lasting about 2 hours. Each session involves an easy walk through a forest area, interspersed with non-intrusive activities of contact with the surrounding nature aimed at fostering mindfulness and the use of the five senses. Data were collected at baseline, post intervention, and 7 months of follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intellectual Disability
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Forest bathing
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Forest bathing
Intervention Description
The intervention consists of 11 consecutive sessions of forest bathing (one session per week), each one lasting about 2 hours. Each session involves an easy walk through a forest area, interspersed with non-intrusive activities of contact with the surrounding nature aimed at fostering mindfulness and the use of the five senses.
Primary Outcome Measure Information:
Title
Systolic and diastolic blood pressure
Time Frame
1 minute
Title
Heart coherence
Description
Using emWave Pro Plus device and software
Time Frame
5 minutes
Title
Perceived quality of life and wellbeing
Description
Using INICO-FEAPS questionnaire (Verdugo Alonso et al., 2013): Scale for the Integral Evaluation of the Quality of Life of people with intellectual or developmental disability, developed by the University Institute for Community Integration (INICO) and the Spanish Confederation of Organizations for People with Intellectual or Developmental Disability (FEAPS).
It is a self-report tool that consists of 72 four-point Likert-type items divided among 8 dimensions: self-determination, rights, emotional wellbeing, social inclusion, personal development, interpersonal relationships, material well-being, and physical well-being. Each dimension is composed of nine items. Each subscale score is calculated by summing up the score for each of the nine items, and a total score is then calculated by summing up the scale scores. Higher scores are associated to better quality of life.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Physiological Equivalent Temperature
Description
Following Höppe (1999) procedure
Time Frame
10 minutes
Title
Thermic perception
Description
Using questionnaire published in previous studies (Teli et al., 2012; Trebilcock et al., 2017), that includes 3 items to assess thermal sensation vote (TMV) (7-point Likert scale), one item to assess thermal preference vote (TPV) (3-point scale), one item to assess the feeling of comfort (closed-answer), one item to get clothing information (closed-answer), and one item to evaluate the feeling of tiredness (3-point scale). The answers to these questions put the PET value (outcome 4) into context and help interpret it.
Time Frame
3 minutes
Title
Barriers and facilitators
Description
Field diary
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adults with intellectual disability enrolled in a specific occupational center.
Being informed about the study and having signed the informed consent document.
Exclusion Criteria:
Having stated their not willing to participate in the study
Facility Information:
Facility Name
Universidad de Navarra
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
10552310
Citation
Hoppe P. The physiological equivalent temperature - a universal index for the biometeorological assessment of the thermal environment. Int J Biometeorol. 1999 Oct;43(2):71-5. doi: 10.1007/s004840050118.
Results Reference
background
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Pilot Project of Forest Bathing for Promoting Health
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