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Heart Rate VariabilityNCT06797804

Effectiveness of Information Technology-Assisted Horticultural Therapy Program on Heart Rate Variability, Stress, Depression and Happiness Among Older Adults Resident in Long-Term Care Facilities

A study testing Information Technology-Assisted Horticultural Therapy Program in people with Heart Rate Variability and Stress, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to address existing research gaps by investigating the effects of technology-assisted horticultural therapy on stress, depression, and happiness among older adults residing in long-term care facilities. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Heart Rate Variability, Stress, Depression
What is being tested?
Information Technology-Assisted Horticultural Therapy Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
76 participants
Where
1 siteTaiwan
Study dates
14 Nov 2024to 8 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • Agree to participate in this study
  • Elderly persons aged 65 and above living in long-term care facilities
  • Live in long-term care facilities for at least three months
  • No gender restrictions
  • Be aware, able to communicate in Mandarin and Taiwanese, and be able to express opinions
  • The upper limbs can move freely and there is no disease that causes tremors in the hands (such as Parkinson's disease, hepatic encephalopathy, etc.)

Who cannot join

  • Has participated in gardening-related activities within one month of receiving the case
  • Those diagnosed with terminal illness or whose health condition is rapidly deteriorating
  • Those suffering from Parkinson's disease, serious heart disease, dementia, mental illness (e.g. schizophrenia, bipolar disorder, etc.)
  • Mini-Mental State Examination (MMSE) with cognitive impairment (MMSE scores below 16 points for individuals with no formal education, below 21 points for those with elementary education, and below 24 points for those with junior high school education or higher.)
  • Those who are unable to participate in the event due to severe speech, vision or hearing impairment

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan1 site, 1 recruiting
  • National Taipei University of Nursing and Health Sciences

    Taipei

    Jung Chia Hsieh, PhD, +886(2)2822-7101 ext. 3135, chiajung@ntunhs.edu.tw

    Recruiting

Other trials in Taiwan

About this study

This study aims to address existing research gaps by investigating the effects of technology-assisted horticultural therapy on stress, depression, and happiness among older adults residing in long-term care facilities. By examining the modulation of the autonomic nervous system, the findings will provide a foundation for developing comprehensive health promotion programs that integrate traditional therapeutic practices with modern technology to enhance the well-being of the aging population.

Read the detailed description

The mental health needs of older adults are a growing concern, and as technology advances, integrating health information with technology can improve healthcare quality and dissemination efficiency. Integrating health information with technology holds promise for enhancing healthcare quality and dissemination efficiency in practical applications, thereby equipping more individuals with accurate health maintenance knowledge. Particularly notable is the increasing trend in internet usage among modern seniors, which contributes to achieving United Nations Sustainable Development Goals. Horticultural therapy has been widely acknowledged for its positive impact on human well-being in various settings. However, its integration with information technology remains relatively unexplored. Additionally, studies on its effectiveness in relieving stress have demonstrated inconsistent effects on heart rate variability. Therefore, this study aims to examine how technology-assisted horticultural therapy influences stress, depression, and happiness among older adult residents in long-term care facilities, with a specific focus on regulating the autonomic nervous system. The study will employ both subjective questionnaire surveys and objective measurements of heart rate. This study proposes a cluster randomized controlled trial. Using G-Power 3.1, a minimum sample size of 76 participants is calculated, accounting for an estimated 20% attrition rate. To ensure equitable distribution between intervention and control groups, each group will consist of at least 38 participants. The intervention involves technology-assisted horticultural therapy sessions conducted once a week, lasting 120 minutes per session, over a total period of 8 weeks. The research will employ several tools: (1) a basic demographic questionnaire, (2) the Mini-Mental State Examination (MMSE), (3) the 'Taiwan Scientific' Noninvasive Blood Pressure Meter (TS 0411), (4) the Perceived Stress Scale (PSS), (5) the Geriatric Depression Scale (GDS-15), and (6) the 5-item World Health Organization Well-Being Index (WHO-5). Data collection will span pre-, mid-, and post-intervention periods over 8 weeks for both experimental and control groups. The Efficacy of Horticultural Therapy Evaluation Form (EHTE) will also be used to conduct pre-test and post-test evaluations on the experimental group. Data will be analyzed using SPSS 27.0. Descriptive statistics will be applied to the demographic questionnaire data, while generalized estimating equations (GEE) will analyze pre-, mid-, and post-test questionnaire responses and objective measurements. Empirical evidence from this study will elucidate the impact of technology-assisted horticultural therapy on heart rate variability, stress, depression, and happiness among older adult residents in long-term care facilities. These findings will serve as a basis for developing health pro-motion programs aimed at enhancing the physical and mental well-being of aging populations.

Being tested
Information Technology-Assisted Horticultural Therapy Program
Keywords
Horticultural Therapy, Older adults, Information and communication technology, Mental health
Medical subject headings
Depression, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Information Technology-Assisted Horticultural Therapy ProgramOther

    Also called Horticultural Therapy, Horticultural activity, horticultural intervention

    The intervention involves technology-assisted horticultural therapy sessions conducted once a week, lasting 120 minutes per session, over a total period of 8 weeks

Study groups in NCT06797804
Study groupRoleWhat they receive
Information Technology-Assisted Horticultural Therapy ProgramExperimentalThe intervention involves technology-assisted horticultural therapy sessions conducted once a week, lasting 120 minutes per session, over a total period of 8 weeks.
Receives: Other: Information Technology-Assisted Horticultural Therapy Program
Routine CareNo interventionNo intervention will be applied to the routine care group.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Heart Rate Variability, HRV

    The most frequently used method for Autonomic Nervous System (ANS) test. Heart rate variability (HRV) represents total activity index of ANS; The higher the HRV, the better the ANS control.

    Measured: Baseline, pre-intervention (T0)

  2. Perceived Stress Scale, PSS

    The total score serves as an overall indicator of stress levels. It demonstrates good internal reliability, with a Cronbach's alpha coefficient of 0.85. The scale comprises 14 items, the total score ranges from 0 to 56, with higher scores indicating greater perceived stress.

    Measured: Baseline, pre-intervention (T0)

  3. Geriatric Depression Scale, GDS-15

    The Geriatric Depression Scale (GDS) is a widely used screening tool designed to identify depression in older adults. The GDS-15 has been translated and adapted for use in various cultural contexts, including Chinese-speaking populations. The scale demonstrated good reliability (Cronbach's α = .94). The total score ranging from 0 to 15. The higher scores indicate greater severity of depressive symptoms.

    Measured: Baseline, pre-intervention (T0)

  4. The 5-item World Health Organization Well-Being Index, WHO-5

    The WHO-5 Well-Being Index is a brief, universally applicable global scale for measuring subjective well-being. The scale consists of five items, each scored from 0 to 5. The raw score ranges from 0 to 25, with higher scores indicating greater well-being. The raw score is often multiplied by 4 to convert it to a percentage scale ranging from 0 to 100.

    Measured: Baseline, pre-intervention (T0)

  5. The efficacy of horticultural therapy evaluation form; EHTE

    The scale used to measure the well-being gained from horticultural therapy defines well-being as a state where an individual can demonstrate their abilities, cope with daily stress, be effective and productive at work, and contribute to society. The Cronbach's α value was 0.724, indicating good reliability. The total score ranging from 7 to 35. The higher the score and the larger the difference between pre- and post-tests, the greater the well-being gained by participants in the horticultural therapy.

    Measured: Baseline, pre-intervention (T0)

  6. Heart Rate Variability, HRV

    The most frequently used method for Autonomic Nervous System (ANS) test. Heart rate variability (HRV) represents total activity index of ANS; The higher the HRV, the better the ANS control.

    Measured: 4 weeks after intervention (T1)

  7. Perceived Stress Scale, PSS

    The total score serves as an overall indicator of stress levels. It demonstrates good internal reliability, with a Cronbach's alpha coefficient of 0.85. The scale comprises 14 items, the total score ranges from 0 to 56, with higher scores indicating greater perceived stress.

    Measured: 4 weeks after intervention (T1)

  8. Geriatric Depression Scale, GDS-15

    The Geriatric Depression Scale (GDS) is a widely used screening tool designed to identify depression in older adults. The GDS-15 has been translated and adapted for use in various cultural contexts, including Chinese-speaking populations. The scale demonstrated good reliability (Cronbach's α = .94). The total score ranging from 0 to 15. The higher scores indicate greater severity of depressive symptoms.

    Measured: 4 weeks after intervention (T1)

  9. The 5-item World Health Organization Well-Being Index, WHO-5

    The WHO-5 Well-Being Index is a brief, universally applicable global scale for measuring subjective well-being. The scale consists of five items, each scored from 0 to 5. The raw score ranges from 0 to 25, with higher scores indicating greater well-being. The raw score is often multiplied by 4 to convert it to a percentage scale ranging from 0 to 100.

    Measured: 4 weeks after intervention (T1)

  10. Heart Rate Variability, HRV

    The most frequently used method for Autonomic Nervous System (ANS) test. Heart rate variability (HRV) represents total activity index of ANS; The higher the HRV, the better the ANS control.

    Measured: 8 weeks after intervention (T2)

  11. Perceived Stress Scale, PSS

    The total score serves as an overall indicator of stress levels. It demonstrates good internal reliability, with a Cronbach's alpha coefficient of 0.85. The scale comprises 14 items, the total score ranges from 0 to 56, with higher scores indicating greater perceived stress.

    Measured: 8 weeks after intervention (T2)

  12. Geriatric Depression Scale, GDS-15

    The Geriatric Depression Scale (GDS) is a widely used screening tool designed to identify depression in older adults. The GDS-15 has been translated and adapted for use in various cultural contexts, including Chinese-speaking populations. The scale demonstrated good reliability (Cronbach's α = .94). The total score ranging from 0 to 15. The higher scores indicate greater severity of depressive symptoms.

    Measured: 8 weeks after intervention (T2)

  13. The 5-item World Health Organization Well-Being Index, WHO-5

    The WHO-5 Well-Being Index is a brief, universally applicable global scale for measuring subjective well-being. The scale consists of five items, each scored from 0 to 5. The raw score ranges from 0 to 25, with higher scores indicating greater well-being. The raw score is often multiplied by 4 to convert it to a percentage scale ranging from 0 to 100.

    Measured: 8 weeks after intervention (T2)

  14. The efficacy of horticultural therapy evaluation form; EHTE

    The scale used to measure the well-being gained from horticultural therapy defines well-being as a state where an individual can demonstrate their abilities, cope with daily stress, be effective and productive at work, and contribute to society. The Cronbach's α value was 0.724, indicating good reliability. The total score ranging from 7 to 35. The higher the score and the larger the difference between pre- and post-tests, the greater the well-being gained by participants in the horticultural therapy.

    Measured: 8 weeks after intervention (T2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2025
  2. Study start14 Nov 2024
  3. Primary completion8 Oct 2025 (estimated)
  4. Study completion8 Oct 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
cluster-randomized controlled trial,cRCT
Masking
Single blind
Who is masked
Participant
Enrolment
76 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06797804
Sponsor's protocol ID
SKH-IRB-20240809R
Status last verified
Jan 2025
First submitted
21 Jan 2025
Last updated
28 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Marioni RE, Chatfield M, Brayne C, Matthews FE; Medical Research Council Cognitive Function and Ageing Study Group. The reliability of assigning individuals to cognitive states using the Mini Mental-State Examination: a population-based prospective cohort study. BMC Med Res Methodol. 2011 Sep 6;11:127. doi: 10.1186/1471-2288-11-127.

    PubMed 21896187
  • Ng KST, Sia A, Ng MKW, Tan CTY, Chan HY, Tan CH, Rawtaer I, Feng L, Mahendran R, Larbi A, Kua EH, Ho RCM. Effects of Horticultural Therapy on Asian Older Adults: A Randomized Controlled Trial. Int J Environ Res Public Health. 2018 Aug 9;15(8):1705. doi: 10.3390/ijerph15081705.

    PubMed 30096932
  • Park, S., Lee, A., Son, K., Lee, W., & Kim, D. (2016). Gardening Intervention for Physical and Psychological Health Benefits in Elderly Women at Community Centers. HortTechnology hortte, 26(4), 474-483. https://doi.org/10.21273/HORTTECH.26.4.474

  • Sheikh, J.I. and Yesavage, J.A. (1986) Geriatric Depression Scale (GDS): Recent Evidence and Development of a Shorter Version. Clinical Gerontologist: The Journal of Aging and Mental Health, 5, 165-173. https://doi.org/10.1300/J018v05n01_09

  • Todd RM, Miskovic V, Chikazoe J, Anderson AK. Emotional Objectivity: Neural Representations of Emotions and Their Interaction with Cognition. Annu Rev Psychol. 2020 Jan 4;71:25-48. doi: 10.1146/annurev-psych-010419-051044. Epub 2019 Oct 14.

    PubMed 31610131
  • Topp CW, Ostergaard SD, Sondergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167-76. doi: 10.1159/000376585. Epub 2015 Mar 28.

    PubMed 25831962
  • Tsai YI, Beh J, Ganderton C, Pranata A. Digital interventions for healthy ageing and cognitive health in older adults: a systematic review of mixed method studies and meta-analysis. BMC Geriatr. 2024 Mar 4;24(1):217. doi: 10.1186/s12877-023-04617-3.

    PubMed 38438870
  • Tu PC, Cheng WC, Hou PC, Chang YS. Effects of Types of Horticultural Activity on the Physical and Mental State of Elderly Individuals. Int J Environ Res Public Health. 2020 Jul 20;17(14):5225. doi: 10.3390/ijerph17145225.

    PubMed 32698351
  • Vassanyi I, Szakonyi B, Loi D, Mantur-Vierendeel A, Quintas J, Solinas A, Blazica B, Raffo L, Guicciardi M, Manca A, Gaal B, Rarosi F. Impact of information technology supported serious leisure gardening on the wellbeing of older adults: The Turntable project. Geriatr Nurs. 2024 Jan-Feb;55:339-345. doi: 10.1016/j.gerinurse.2023.12.014. Epub 2023 Dec 29.

    PubMed 38159476
  • Yeo NL, Elliott LR, Bethel A, White MP, Dean SG, Garside R. Indoor Nature Interventions for Health and Wellbeing of Older Adults in Residential Settings: A Systematic Review. Gerontologist. 2020 Apr 2;60(3):e184-e199. doi: 10.1093/geront/gnz019.

    PubMed 30884495
  • Luppa M, Luck T, Weyerer S, Konig HH, Brahler E, Riedel-Heller SG. Prediction of institutionalization in the elderly. A systematic review. Age Ageing. 2010 Jan;39(1):31-8. doi: 10.1093/ageing/afp202. Epub 2009 Nov 23.

    PubMed 19934075
  • Luk KY, Lai KY, Li CC, Cheung WH, Lam SM, Li HY, Ng KP, Shiu WH, So CY, Wan SF. The effect of horticultural activities on agitation in nursing home residents with dementia. Int J Geriatr Psychiatry. 2011 Apr;26(4):435-6. doi: 10.1002/gps.2493. No abstract available.

    PubMed 21412848
  • Lin TY, Huang CM, Hsu HP, Liao JY, Cheng VY, Wang SW, Guo JL. Effects of a Combination of Three-Dimensional Virtual Reality and Hands-on Horticultural Therapy on Institutionalized Older Adults' Physical and Mental Health: Quasi-Experimental Design. J Med Internet Res. 2020 Nov 2;22(11):e19002. doi: 10.2196/19002.

    PubMed 33135666
  • Lai, P. Y., Chen, C.H. (2017). Design an Interactive Game App of Horticultural Therapy for Older Adults. In: Hale, K., Stanney, K. (eds) Advances in Neuroergonomics and Cognitive Engineering. Advances in Intelligent Systems and Computing, 488. Springer, Cham. https://doi.org/10.1007/978-3-319-41691-5_35

  • Lai CKY, Kwan RYC, Lo SKL, Fung CYY, Lau JKH, Tse MMY. Effects of Horticulture on Frail and Prefrail Nursing Home Residents: A Randomized Controlled Trial. J Am Med Dir Assoc. 2018 Aug;19(8):696-702. doi: 10.1016/j.jamda.2018.04.002. Epub 2018 May 24.

    PubMed 29804892

Questions about this trial

What is this clinical trial studying?

A study testing Information Technology-Assisted Horticultural Therapy Program in people with Heart Rate Variability and Stress, run by National Taipei University of Nursing and Health Sciences 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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jung Chia Hsieh, PhD (+886(2)2822-7101 ext. 3135, chiajung@ntunhs.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Heart Rate Variability, HRV (time frame: Baseline, pre-intervention (T0)). The study lists 14 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 NCT06797804, which also lists 28 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 28 Jan 2025.

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