Physical HealthNCT04324203
The Effectiveness of 3DVR Horticultural Therapy on Older Adults
A study testing Three-dimensional Virtual Reality and Horticultural Therapy in people with Physical Health and Mental Health, run by National Taiwan Normal University at 1 site in Taiwan.
Trial summary
This study intends to develop a 3DVR-based horticultural therapy intervention to explore the health effectiveness among older adults Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Physical Health, Mental Health
- What is being tested?
- Three-dimensional Virtual Reality and Horticultural Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2018to 30 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- over 65 years old.
- being a long-term resident of the selected LTCF
- possessing the ability to understand verbal meanings
- being able to freely operate a joystick.
Who cannot join
- a history of severe psychiatric conditions, dementia, significant visual or hearing impairment, and/or current severe illnesses such as stroke or Parkinson's disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of 3DVR Horticultural Therapy on Older Adults' Physical and Mental Health
This study intends to develop a 3DVR-based horticultural therapy intervention to explore the health effectiveness among older adults
Read the detailed description
Background: Institutionalized older adults have limited ability to engage in horticultural activities that can promote their physical and mental health.
Objective: This study explored the effects of a combination of three-dimensional (3D) virtual reality (VR) and horticultural therapy (HT) on institutionalized older adults' physical and mental health.
Methods: The study applied a quasi-experimental design. A total of 106 older adults from two long-term care facilities were recruited and assigned to the experimental (n = 59) or control (n = 47) group. The experimental participants received a nine-week intervention. Both groups completed three assessments: at baseline, after the intervention, and two months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression.
- Conditions
- Physical Health, Mental Health
- Being tested
- Three-dimensional Virtual Reality and Horticultural Therapy
- Keywords
- Horticultural therapy, 3D VR, Older adults, long-term care facility, mental health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional Virtual Reality and Horticultural TherapyOther
VR is a realistic, three-dimensional, and virtual environment formed by a combination of computer software and hardware
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Three-dimensional Virtual Reality and Horticultural Therapy Receives: Other: Three-dimensional Virtual Reality and Horticultural Therapy |
| Control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health Status
To assess the health status of the elderly participants, we used the Chinese Health Scale (CHQ-12). This scale consists of 12 Likert-type items that are scored from 3 (not at all) to 0 (more than usual). The higher the score, the higher the level of general health.
Measured: Two months
Meaning in life.
The meaning in life questionnaire was adapted from the purpose in life (PIL) survey, and it consists of 9 Likert-type items. Each item is scored on a Likert-type scale from 1-5, with higher scores indicating a higher level of perceived meaning in life.
Measured: Two months
Perceived mattering
Perceived mattering was adapted from the General mattering Scale (GMS), and consisted of five items. Each item was scored on a Likert-type scale of 1(not at all) to 4(very much) with higher scores indicating a higher level of perceived mattering.
Measured: Two months
Loneliness
The short-form UCLA Loneliness Scale (ULS-6), which consists of six items, was used to measure loneliness. Each item was reversely scored on a Likert-type scale from 4 (never) to 1 (often), with higher scores indicating a lower level of perceived loneliness.
Measured: Two months
Depression
Using a Chinese version of the short-form of the Geriatric Depression Scale (GDS-15). The total raw score ranged from 0-15, with a higher score indicating a lower level of depression.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Jan 2018
- Primary completion25 Feb 2019
- Study completion30 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Physical HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jong-Long Guo, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324203
- Sponsor's protocol ID
- 201710HM006
- Status last verified
- Mar 2020
- First submitted
- 24 Mar 2020
- Last updated
- 27 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bossen A. The importance of getting back to nature for people with dementia. J Gerontol Nurs. 2010 Feb;36(2):17-22. doi: 10.3928/00989134-20100111-01. Epub 2010 Feb 5.
PubMed 20128524Cheng TA, Williams P. The design and development of a screening questionnaire (CHQ) for use in community studies of mental disorders in Taiwan. Psychol Med. 1986 May;16(2):415-22. doi: 10.1017/s0033291700009247.
PubMed 3726013Lee IM, Paffenbarger RS Jr, Hennekens CH. Physical activity, physical fitness and longevity. Aging (Milano). 1997 Feb-Apr;9(1-2):2-11. doi: 10.1007/BF03340123.
PubMed 9177581Soderback I, Soderstrom M, Schalander E. Horticultural therapy: the 'healing garden'and gardening in rehabilitation measures at Danderyd Hospital Rehabilitation Clinic, Sweden. Pediatr Rehabil. 2004 Oct-Dec;7(4):245-60. doi: 10.1080/13638490410001711416.
PubMed 15513768Grazuleviciene R, Vencloviene J, Kubilius R, Grizas V, Danileviciute A, Dedele A, Andrusaityte S, Vitkauskiene A, Steponaviciute R, Nieuwenhuijsen MJ. Tracking Restoration of Park and Urban Street Settings in Coronary Artery Disease Patients. Int J Environ Res Public Health. 2016 May 31;13(6):550. doi: 10.3390/ijerph13060550.
PubMed 27258294Chan HY, Ho RC, Mahendran R, Ng KS, Tam WW, Rawtaer I, Tan CH, Larbi A, Feng L, Sia A, Ng MK, Gan GL, Kua EH. Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial. BMC Geriatr. 2017 Aug 29;17(1):192. doi: 10.1186/s12877-017-0588-z.
PubMed 28851276Han AR, Park SA, Ahn BE. Reduced stress and improved physical functional ability in elderly with mental health problems following a horticultural therapy program. Complement Ther Med. 2018 Jun;38:19-23. doi: 10.1016/j.ctim.2018.03.011. Epub 2018 Mar 28.
PubMed 29857876Yao YF, Chen KM. Effects of horticulture therapy on nursing home older adults in southern Taiwan. Qual Life Res. 2017 Apr;26(4):1007-1014. doi: 10.1007/s11136-016-1425-0. Epub 2016 Oct 1.
PubMed 27696109Stern C, Konno R. Physical Leisure Activities and their Role in Preventing Dementia: A Systematic Review. JBI Libr Syst Rev. 2009;7(8):260-308. doi: 10.11124/01938924-200907080-00001.
PubMed 27820066Chen YM, Ji JY. Effects of Horticultural Therapy on Psychosocial Health in Older Nursing Home Residents: A Preliminary Study. J Nurs Res. 2015 Sep;23(3):167-71. doi: 10.1097/jnr.0000000000000063.
PubMed 25534575Liu Y, Bo L, Sampson S, Roberts S, Zhang G, Wu W. Horticultural therapy for schizophrenia. Cochrane Database Syst Rev. 2014 May 19;2014(5):CD009413. doi: 10.1002/14651858.CD009413.pub2.
PubMed 24842458Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.
PubMed 16952717
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of 3DVR Horticultural Therapy on Older Adults' Physical and Mental Health
- ClinicalTrials.gov ID
- NCT04324203
- Acronym / sponsor ID
- 201710HM006
- Conditions
- Physical Health, Mental Health
- Keywords
- Horticultural therapy, 3D VR, Older adults, long-term care facility, mental health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- National Taiwan Normal UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 25 Feb 2019 (actual)
- Study completion
- 30 Jun 2019 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to develop a 3DVR-based horticultural therapy intervention to explore the health effectiveness among older adults
Detailed description
Background: Institutionalized older adults have limited ability to engage in horticultural activities that can promote their physical and mental health.
Objective: This study explored the effects of a combination of three-dimensional (3D) virtual reality (VR) and horticultural therapy (HT) on institutionalized older adults' physical and mental health.
Methods: The study applied a quasi-experimental design. A total of 106 older adults from two long-term care facilities were recruited and assigned to the experimental (n = 59) or control (n = 47) group. The experimental participants received a nine-week intervention. Both groups completed three assessments: at baseline, after the intervention, and two months later. The outcome variables included health status, meaning in life, perceived mattering, loneliness, and depression.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Three-dimensional Virtual Reality and Horticultural TherapyThree-dimensional Virtual Reality and Horticultural Therapy |
| Control group | No intervention | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- over 65 years old.
- being a long-term resident of the selected LTCF
- possessing the ability to understand verbal meanings
- being able to freely operate a joystick.
Key exclusion criteria (1 listed)
- a history of severe psychiatric conditions, dementia, significant visual or hearing impairment, and/or current severe illnesses such as stroke or Parkinson's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional Virtual Reality and Horticultural TherapyVR is a realistic, three-dimensional, and virtual environment formed by a combination of computer software and hardware | Other | Experimental group |
Primary outcome
Health Status
Time frame: Two months
To assess the health status of the elderly participants, we used the Chinese Health Scale (CHQ-12). This scale consists of 12 Likert-type items that are scored from 3 (not at all) to 0 (more than usual). The higher the score, the higher the level of general health.
Meaning in life.
Time frame: Two months
The meaning in life questionnaire was adapted from the purpose in life (PIL) survey, and it consists of 9 Likert-type items. Each item is scored on a Likert-type scale from 1-5, with higher scores indicating a higher level of perceived meaning in life.
Perceived mattering
Time frame: Two months
Perceived mattering was adapted from the General mattering Scale (GMS), and consisted of five items. Each item was scored on a Likert-type scale of 1(not at all) to 4(very much) with higher scores indicating a higher level of perceived mattering.
Loneliness
Time frame: Two months
The short-form UCLA Loneliness Scale (ULS-6), which consists of six items, was used to measure loneliness. Each item was reversely scored on a Likert-type scale from 4 (never) to 1 (often), with higher scores indicating a lower level of perceived loneliness.
Depression
Time frame: Two months
Using a Chinese version of the short-form of the Geriatric Depression Scale (GDS-15). The total raw score ranged from 0-15, with a higher score indicating a lower level of depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Background: PubMed 20128524Bossen A. The importance of getting back to nature for people with dementia. J Gerontol Nurs. 2010 Feb;36(2):17-22. doi: 10.3928/00989134-20100111-01. Epub 2010 Feb 5.
- Background: PubMed 3726013Cheng TA, Williams P. The design and development of a screening questionnaire (CHQ) for use in community studies of mental disorders in Taiwan. Psychol Med. 1986 May;16(2):415-22. doi: 10.1017/s0033291700009247.
- Background: PubMed 9177581Lee IM, Paffenbarger RS Jr, Hennekens CH. Physical activity, physical fitness and longevity. Aging (Milano). 1997 Feb-Apr;9(1-2):2-11. doi: 10.1007/BF03340123.
- Background: PubMed 15513768Soderback I, Soderstrom M, Schalander E. Horticultural therapy: the 'healing garden'and gardening in rehabilitation measures at Danderyd Hospital Rehabilitation Clinic, Sweden. Pediatr Rehabil. 2004 Oct-Dec;7(4):245-60. doi: 10.1080/13638490410001711416.
- Background: PubMed 27258294Grazuleviciene R, Vencloviene J, Kubilius R, Grizas V, Danileviciute A, Dedele A, Andrusaityte S, Vitkauskiene A, Steponaviciute R, Nieuwenhuijsen MJ. Tracking Restoration of Park and Urban Street Settings in Coronary Artery Disease Patients. Int J Environ Res Public Health. 2016 May 31;13(6):550. doi: 10.3390/ijerph13060550.
- Background: PubMed 28851276Chan HY, Ho RC, Mahendran R, Ng KS, Tam WW, Rawtaer I, Tan CH, Larbi A, Feng L, Sia A, Ng MK, Gan GL, Kua EH. Effects of horticultural therapy on elderly' health: protocol of a randomized controlled trial. BMC Geriatr. 2017 Aug 29;17(1):192. doi: 10.1186/s12877-017-0588-z.
- Background: PubMed 29857876Han AR, Park SA, Ahn BE. Reduced stress and improved physical functional ability in elderly with mental health problems following a horticultural therapy program. Complement Ther Med. 2018 Jun;38:19-23. doi: 10.1016/j.ctim.2018.03.011. Epub 2018 Mar 28.
- Background: PubMed 27696109Yao YF, Chen KM. Effects of horticulture therapy on nursing home older adults in southern Taiwan. Qual Life Res. 2017 Apr;26(4):1007-1014. doi: 10.1007/s11136-016-1425-0. Epub 2016 Oct 1.
- Background: PubMed 27820066Stern C, Konno R. Physical Leisure Activities and their Role in Preventing Dementia: A Systematic Review. JBI Libr Syst Rev. 2009;7(8):260-308. doi: 10.11124/01938924-200907080-00001.
- Background: PubMed 25534575Chen YM, Ji JY. Effects of Horticultural Therapy on Psychosocial Health in Older Nursing Home Residents: A Preliminary Study. J Nurs Res. 2015 Sep;23(3):167-71. doi: 10.1097/jnr.0000000000000063.
- Background: PubMed 24842458Liu Y, Bo L, Sampson S, Roberts S, Zhang G, Wu W. Horticultural therapy for schizophrenia. Cochrane Database Syst Rev. 2014 May 19;2014(5):CD009413. doi: 10.1002/14651858.CD009413.pub2.
- Background: PubMed 16952717Heinrich LM, Gullone E. The clinical significance of loneliness: a literature review. Clin Psychol Rev. 2006 Oct;26(6):695-718. doi: 10.1016/j.cpr.2006.04.002. Epub 2006 Jun 19.
- Individual participant dataSharing planned: No
Related trials for Physical Health
Not yet recruitingObservational study
Validation of the Healthcare Relationship Assessment Scale (ERA) in Health Sciences Students.
Health Adult Subjects, Communication
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingPhase 2
Alberta Cancer Exercise Dose in Colorectal Cancer
Cancer, Colorectal Cancer
Recruiting
An Online Intuitive Eating Program for Pregnant Women With Obesity to Support Well-Being
Excessive Gestational Weight Gain, Pregnancy
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jong-Long Guo principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-dimensional Virtual Reality and Horticultural Therapy in people with Physical Health and Mental Health, run by National Taiwan Normal University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Status (time frame: Two months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04324203, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2020.