Intellectual Disability Clinical Trial
Official title:
FOREST HEALTH: Pilot Project of Forest Bathing for Promoting Health, Human Wellbeing, and for Complementing Sustainable Management Forest and Landscape Practices
NCT number | NCT05472571 |
Other study ID # | BOSQUE |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2021 |
Est. completion date | March 15, 2022 |
Verified date | July 2022 |
Source | Clinica Universidad de Navarra, Universidad de Navarra |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 28 |
Est. completion date | March 15, 2022 |
Est. primary completion date | July 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Spain | Universidad de Navarra | Pamplona | Navarra |
Lead Sponsor | Collaborator |
---|---|
Clinica Universidad de Navarra, Universidad de Navarra | Fundación Caja Navarra, Fundación La Caixa |
Spain,
Höppe 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Systolic and diastolic blood pressure | 1 minute | ||
Primary | Heart coherence | Using emWave Pro Plus device and software | 5 minutes | |
Primary | 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. |
30 minutes | |
Secondary | Physiological Equivalent Temperature | Following Höppe (1999) procedure | 10 minutes | |
Secondary | 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. | 3 minutes | |
Secondary | Barriers and facilitators | Field diary | 2 hours |
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