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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date July 2022
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Forest bathing
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.

Locations

Country Name City State
Spain Universidad de Navarra Pamplona Navarra

Sponsors (3)

Lead Sponsor Collaborator
Clinica Universidad de Navarra, Universidad de Navarra Fundación Caja Navarra, Fundación La Caixa

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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

Outcome

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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