NCT05472571

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 19, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 25, 2022

Completed
Last Updated

July 25, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 19, 2022

Last Update Submit

July 22, 2022

Conditions

Intellectual Disability

Outcome Measures

Primary Outcomes (3)

  • Systolic and diastolic blood pressure

    1 minute

  • Heart coherence

    Using emWave Pro Plus device and software

    5 minutes

  • 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 Outcomes (3)

  • Physiological Equivalent Temperature

    10 minutes

  • Thermic perception

    3 minutes

  • Barriers and facilitators

    2 hours

Study Arms (1)

Forest bathing

EXPERIMENTAL
Other: Forest bathing

Interventions

Forest bathingOTHER

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.

Forest bathing

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults with intellectual disability enrolled in a specific occupational center.
  • Being informed about the study and having signed the informed consent document.

You may not qualify if:

  • Having stated their not willing to participate in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad de Navarra

Pamplona, Navarre, 31008, Spain

Location

Related Publications (1)

  • 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.

    PMID: 10552310BACKGROUND

MeSH Terms

Conditions

Intellectual Disability

Interventions

Forest Therapy

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Relaxation TherapyMind-Body TherapiesComplementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 19, 2022

First Posted

July 25, 2022

Study Start

May 1, 2021

Primary Completion

July 31, 2021

Study Completion

March 15, 2022

Last Updated

July 25, 2022

Record last verified: 2022-07

Locations

ES(1)