3D VR and Hands-on Horticultural Activities Effects

October 8, 2021 updated by: National Taiwan Normal University

The Effects of a Combination of 3D Virtual Reality and Hands-on Horticultural Activities on Community-dwelling Older Adults' Mental Health: A Quasi-Experimental Study

This study aimed to explore the effects of a combination of 3D virtual reality (VR) and hands-on horticultural activities on the mental health of community-dwelling older adults.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Aging societies are of public health concern worldwide. It is critical to develop strategies that harness technology to enhance older adults' mental health. This study aimed to explore the effects of a combination of three-dimensional virtual reality (3D VR) and hands-on horticultural activities on the mental health of community-dwelling older adults. Used a quasi-experimental design. A total of 62 community-dwelling older adults were recruited. The members of the experimental group participated in an 8-week intervention program. Participants of both groups completed before-and-after intervention measurements for outcome variables that included perceived self-esteem, depression, isolation, mastery and achievement motives, which were analyzed using the generalized estimating equation (GEE). This study found beneficial effects of a combination of 3D VR and hands-on horticultural activities on community-dwelling older adults' mental health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
62

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 106
        • National Taiwan Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Intact cognition, possessing the ability to understand verbal meaning and the ability to operate a VR joystick independently.

Exclusion Criteria:

A history of hand dysfunction, severe visual and hearing impairment, being allergic to plants or pollen, and a current illness such as epilepsy or stroke.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Experimental group
Received the Combination of 3D VR and Hands-on Horticultural Activities.
Other: Combination of 3D VR and Hands-on Horticultural Activities
The intervention program consisted of 8 two-hour sessions that were conducted once a week for 8 consecutive weeks.
NO_INTERVENTION: Comparison group
Received scheduled activities, such as physical fitness, paper cutting, etc., without any gardening activities.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Self-esteem
Time Frame: about three months
Rosenberg Self-Esteem Scale consists of 14 items and each item is scored on a Likert-type scale that ranges from 1 (strongly agree) to 4 (strongly disagree), with higher scores indicating a higher level of self-esteem.
about three months
Depression
Time Frame: about three months
The Chinese version of the Geriatric Depression Scale was used, which has a total of 15 items. All items were answered as either yes (1) or no (0). The total raw scores ranged from 0 to 15, with a higher score indicating a higher level of depression.
about three months
Perceived isolation
Time Frame: about three months
A short-form scale of perceived isolation was used to measure isolation. Each item was scored on a Likert-type scale from 1 (never) to 4 (often), with higher scores indicating a higher level of perceived isolation.
about three months
Perceived mastery
Time Frame: about three months
The Chinese version of the Perceived Mastery Scale with a total of 7 items was used. Each item was scored on a Likert-type scale from 1 (strongly agree) to 4 (strongly disagree). The total raw score ranged from 7 to 28, with a higher score indicating a higher level of perceived mastery.
about three months
Achievement motives
Time Frame: about three months
The Achievement Motives Scale (AMS) consists of two kinds of motives, referred to as Motive to Achieve Success, (MAS) and Motive to Avoid Failure (MAF). A short-form scale with 10 items was used to measure achievement motives, with 5 items each for MAS and MAF. Each item was scored on a Likert-type scale from 1 (strongly agree) to 4 (strongly disagree).
about three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taiwan Normal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2020

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 8, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 21, 2021

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECKIRB1090503

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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