CognitionNCT06844084
Biopsychosocial Effects of Gardening Activities
A study testing Gardening Activity in people with Cognition and Anxiety, run by Ordu University.
Trial summary
Due to the increasing number of elderly population worldwide, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cognition, Anxiety, Depression
- What is being tested?
- Gardening Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2025to 1 Aug 2025
- 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
- Elderly people who have been living in a nursing home for at least 6 months,
- Elderly people with a mini mental test score of 24 and above,
- Elderly people who do not have vision or hearing loss that may prevent gardening activities,
- Elderly people who are open to communication and cooperation and who volunteer to participate in the study will be included in the study.
Who cannot join
- Elderly people with physical (such as stroke, Parkinson's) and psychiatric diseases (such as mental retardation) that may prevent gardening activities,
- Elderly people with chronic diseases in the exacerbation process (heart failure, chronic renal failure, etc.) will be excluded from the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Biopsychosocial Effects of Gardening Activities on Elderly People in Nursing Homes
Due to the increasing number of elderly population worldwide, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. With the project, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.
Read the detailed description
Improvement of living conditions, development of health services and technology lead to prolonged life expectancy and accordingly, the number of elderly population is gradually increasing. For this reason, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. The elderly in nursing homes may experience many physical, mental and social problems. The elderly in nursing homes may experience problems such as decreased self-esteem, increased dependency in daily living activities, chronic diseases, fear of death, lack of social support, cognitive deficiencies, anxiety due to environmental and lifestyle changes, depression and lack of life satisfaction. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. Gardening activities positively affect the sense of commitment and success, self-expression, social interaction, sense of responsibility, self-esteem, cognitive skills and creativity in the elderly. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. In the literature, it is seen that studies examining the effects of gardening activities on the health of the elderly have been carried out, but the studies on this subject in our country are very limited. With the project, for the first time in our country, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.
- Conditions
- Cognition, Anxiety, Depression, Life Satisfaction, Psychological Well Being
- Being tested
- Gardening Activity
- Keywords
- Elderly, Gardening Activity, Psychological Well Being, Anxiety, Depression, Life Satisfaction
- Medical subject headings
- Anxiety Disorders, Depression, Personal Satisfaction, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gardening ActivityOther
In the project, gardening activities will be applied to the participants in the experimental group in the nursing home and greenhouse for 16 weeks (4 months), once a week for 60 minutes. During the implementation phase of horticulture activities, information meetings will be held in the meeting room of the nursing home in one group. In addition, 20 minutes break will be given during the activity in terms of the tolerance of the elderly to gardening activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In the project, gardening activities will be applied to the participants in the experimental group once a week for 60 minutes for 16 weeks (4 months) in a nursing home and greenhouse. In the project, the elderly will be informed about gardening activities in the nursing home. The applications will be carried out in the greenhouse. Receives: Other: Gardening Activity |
| Control Group | No intervention | Participants in the control group will not receive any intervention during the study. They will participate in routine activities in the nursing home (crafts such as philography, relief, knitting, and folk dances and bocce games in the atelier). After the final tests are administered in the study, participants in the control group will be engaged in gardening activities for 60 minutes once a week for 4 weeks (1 month) (this period was determined by taking the project duration into account). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Anxiety Inverntory
The scale developed by Pachana et al. (2007) was adapted to Turkish by Pamir Akın (2010). The Geriatric Anxiety Inventory aims to measure anxiety symptoms in the elderly in a dimensional manner. The cut-off point of the scale for generalized anxiety disorder was determined as 10/11. Accordingly, the scale was organized as "anxiety symptoms and generalized anxiety disorder > 10; only anxiety symptoms < 10". There are no reverse-coded items in the scale, which consists of 20 items and is scored on two dimensions as "agree" and "disagree". Accordingly, 1 point is given for the "agree" option and 0 points for the "disagree" option. Therefore, the scores obtained from the scale can vary between 0 and 20. Cronbach's α for the normal elderly sample was found to be 0.91, and Cronbach's α for the psychogeriatric sample was found to be 0.93.
Measured: At the beginning of the study and end of 16 weeks treatment
Geriatric Depression Scale
The scale developed by Yesavage et al. (1993) is based on self-reporting. The short form of the GDS consisting of 15 questions will be used in this study. The Turkish validity and reliability study of the scale was conducted by Ertan et al. (1997). 5 questions (1, 5, 7, 11 and 13) in the scale were designed positively, the others were designed negatively. In the evaluation of the scale, "no" answers to positive questions and "yes" answers to negative questions were matched with 1 point. The scores that can be obtained from the scale are between 0-15. A score above five is considered depression. The Cronbach alpha value of the scale is 0.92.
Measured: At the beginning of the study and end of 16 weeks treatment
Life Satisfaction in the Elderly Scale
The scale was developed by Altay and Çalmaz (2022) and consists of a total of 14 items and 3 sub-dimensions. The scale was prepared as a Likert-type, five-point scale (1= Strongly disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree, 5= Strongly agree). The score that can be obtained from ELS varies between 14 and 70. A high score indicates that the individual has high life satisfaction. ELS contains a three-factor structure. Self-acceptance (Factor 1) of the sub-dimensions of the scale includes items 5, 6, 8, 9, 16, 21, 25, 27, 28, Motivation (Factor 2) includes items 11 and 13, and Peace (Factor 3) includes items 10, 12, and 14. Sub-dimension scores are calculated by adding the scores of the items in each sub-dimension and dividing them by the number of items. Each sub-dimension is scored between '1' and '5'. The self-acceptance sub-dimension score range is minimum - maximum 9-45, the motivation sub-dimension score range is minimum - m
Measured: At the beginning of the study and end of 16 weeks treatment
Psychological Well-Being Scale for Older People
It was developed by Gümüş Demir (2022) to measure happiness and well-being in elderly individuals, and has a 15-item and single-factor structure. Items 8 and 13 are reverse coded. The single-factor structure of the scale was tested in a different sample group with the CFA method and the result that the structure was confirmed was obtained. The scale was found to be a valid and reliable measurement tool for measuring psychological well-being in the elderly. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.89.
Measured: At the beginning of the study and end of 16 weeks treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start3 Mar 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CognitionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was planned as a single-blind randomized controlled experimental study. Randomized controlled experimental studies are the research design that is the source of evidence-based information on the applicability of a particular intervention, determines causality and is the basic source for systematic reviews and meta-analyses that are evaluated as first-level evidence. In this project, a randomized controlled study design was chosen to examine the biopsychosocial effects of gardening activities applied to elderly people in nursing homes and to obtain high-level evidence results. Blinding is performed to prevent bias in randomized controlled studies (Akın and Koçoğlu, 2017). In this project, participants and analyzers can be blinded to prevent bias, therefore, the study was planned to be conducted in a single-blind randomized controlled experimental design.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hacer Gok Ugur, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844084
- Sponsor's protocol ID
- OrduBAP
- Status last verified
- Feb 2025
- First submitted
- 19 Feb 2025
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biopsychosocial Effects of Gardening Activities on Elderly People in Nursing Homes
- ClinicalTrials.gov ID
- NCT06844084
- Acronym / sponsor ID
- OrduBAP
- Conditions
- Cognition, Anxiety, Depression, Life Satisfaction, Psychological Well Being
- Keywords
- Elderly, Gardening Activity, Psychological Well Being, Anxiety, Depression, Life Satisfaction
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 25 Feb 2025 (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.
Due to the increasing number of elderly population worldwide, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. With the project, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.
Detailed description
Improvement of living conditions, development of health services and technology lead to prolonged life expectancy and accordingly, the number of elderly population is gradually increasing. For this reason, elderly care is becoming increasingly important and the number of elderly in institutional care is increasing. The elderly in nursing homes may experience many physical, mental and social problems. The elderly in nursing homes may experience problems such as decreased self-esteem, increased dependency in daily living activities, chronic diseases, fear of death, lack of social support, cognitive deficiencies, anxiety due to environmental and lifestyle changes, depression and lack of life satisfaction. In this context, the implementation of easily applicable, cost-effective and accessible physical activity programmes for the elderly in nursing homes is important for the physical, mental and social health of the elderly. Gardening activities are a non-pharmacological intervention that has recently increased in popularity in the elderly and can be easily applied. Gardening activities positively affect the sense of commitment and success, self-expression, social interaction, sense of responsibility, self-esteem, cognitive skills and creativity in the elderly. It is known that gardening activities in the elderly affect some biochemical parameters along with mental health effects and reduce stress, especially by reducing cortisol levels. By providing physical mobility in the elderly with gardening activities, there may be an increase in irisin level and BDNF level, which is an indicator of improvement in cognitive functions, and a decrease in cortisol level, which is an indicator of stress. In the literature, it is seen that studies examining the effects of gardening activities on the health of the elderly have been carried out, but the studies on this subject in our country are very limited. With the project, for the first time in our country, the effects of gardening activities on the elderly will be examined comprehensively in a biopsychosocial manner. In this project, the effects of gardening activities on anxiety, depression, life satisfaction, psychological well-being and biochemical parameters will be examined in the elderly living in a nursing home. In the project, gardening activities will be applied to the elderly in the experimental group once a week for 60 minutes for 16 weeks (4 months). With the project, it is aimed to strengthen the elderly biopsychosocially by making them do gardening activities.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study was planned as a single-blind randomized controlled experimental study. Randomized controlled experimental studies are the research design that is the source of evidence-based information on the applicability of a particular intervention, determines causality and is the basic source for systematic reviews and meta-analyses that are evaluated as first-level evidence. In this project, a randomized controlled study design was chosen to examine the biopsychosocial effects of gardening activities applied to elderly people in nursing homes and to obtain high-level evidence results. Blinding is performed to prevent bias in randomized controlled studies (Akın and Koçoğlu, 2017). In this project, participants and analyzers can be blinded to prevent bias, therefore, the study was planned to be conducted in a single-blind randomized controlled experimental design.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Gardening ActivityIn the project, gardening activities will be applied to the participants in the experimental group once a week for 60 minutes for 16 weeks (4 months) in a nursing home and greenhouse. In the project, the elderly will be informed about gardening activities in the nursing home. The applications will be carried out in the greenhouse. |
| Control Group | No intervention | –Participants in the control group will not receive any intervention during the study. They will participate in routine activities in the nursing home (crafts such as philography, relief, knitting, and folk dances and bocce games in the atelier). After the final tests are administered in the study, participants in the control group will be engaged in gardening activities for 60 minutes once a week for 4 weeks (1 month) (this period was determined by taking the project duration into account). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Elderly people who have been living in a nursing home for at least 6 months,
- Elderly people with a mini mental test score of 24 and above,
- Elderly people who do not have vision or hearing loss that may prevent gardening activities,
- Elderly people who are open to communication and cooperation and who volunteer to participate in the study will be included in the study.
Key exclusion criteria (2 listed)
- Elderly people with physical (such as stroke, Parkinson's) and psychiatric diseases (such as mental retardation) that may prevent gardening activities,
- Elderly people with chronic diseases in the exacerbation process (heart failure, chronic renal failure, etc.) will be excluded from the study.
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 |
|---|---|---|
| Gardening ActivityIn the project, gardening activities will be applied to the participants in the experimental group in the nursing home and greenhouse for 16 weeks (4 months), once a week for 60 minutes. During the implementation phase of horticulture activities, information meetings will be held in the meeting room of the nursing home in one group. In addition, 20 minutes break will be given during the activity in terms of the tolerance of the elderly to gardening activities. | Other | Experimental Group |
Primary outcome
Geriatric Anxiety Inverntory
Time frame: At the beginning of the study and end of 16 weeks treatment
The scale developed by Pachana et al. (2007) was adapted to Turkish by Pamir Akın (2010). The Geriatric Anxiety Inventory aims to measure anxiety symptoms in the elderly in a dimensional manner. The cut-off point of the scale for generalized anxiety disorder was determined as 10/11. Accordingly, the scale was organized as "anxiety symptoms and generalized anxiety disorder > 10; only anxiety symptoms < 10". There are no reverse-coded items in the scale, which consists of 20 items and is scored on two dimensions as "agree" and "disagree". Accordingly, 1 point is given for the "agree" option and 0 points for the "disagree" option. Therefore, the scores obtained from the scale can vary between 0 and 20. Cronbach's α for the normal elderly sample was found to be 0.91, and Cronbach's α for the psychogeriatric sample was found to be 0.93.
Geriatric Depression Scale
Time frame: At the beginning of the study and end of 16 weeks treatment
The scale developed by Yesavage et al. (1993) is based on self-reporting. The short form of the GDS consisting of 15 questions will be used in this study. The Turkish validity and reliability study of the scale was conducted by Ertan et al. (1997). 5 questions (1, 5, 7, 11 and 13) in the scale were designed positively, the others were designed negatively. In the evaluation of the scale, "no" answers to positive questions and "yes" answers to negative questions were matched with 1 point. The scores that can be obtained from the scale are between 0-15. A score above five is considered depression. The Cronbach alpha value of the scale is 0.92.
Life Satisfaction in the Elderly Scale
Time frame: At the beginning of the study and end of 16 weeks treatment
The scale was developed by Altay and Çalmaz (2022) and consists of a total of 14 items and 3 sub-dimensions. The scale was prepared as a Likert-type, five-point scale (1= Strongly disagree, 2= Disagree, 3= Neither agree nor disagree, 4= Agree, 5= Strongly agree). The score that can be obtained from ELS varies between 14 and 70. A high score indicates that the individual has high life satisfaction. ELS contains a three-factor structure. Self-acceptance (Factor 1) of the sub-dimensions of the scale includes items 5, 6, 8, 9, 16, 21, 25, 27, 28, Motivation (Factor 2) includes items 11 and 13, and Peace (Factor 3) includes items 10, 12, and 14. Sub-dimension scores are calculated by adding the scores of the items in each sub-dimension and dividing them by the number of items. Each sub-dimension is scored between '1' and '5'. The self-acceptance sub-dimension score range is minimum - maximum 9-45, the motivation sub-dimension score range is minimum - m
Psychological Well-Being Scale for Older People
Time frame: At the beginning of the study and end of 16 weeks treatment
It was developed by Gümüş Demir (2022) to measure happiness and well-being in elderly individuals, and has a 15-item and single-factor structure. Items 8 and 13 are reverse coded. The single-factor structure of the scale was tested in a different sample group with the CFA method and the result that the structure was confirmed was obtained. The scale was found to be a valid and reliable measurement tool for measuring psychological well-being in the elderly. The Cronbach alpha internal consistency coefficient of the scale was found to be 0.89.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Gardening Activity in people with Cognition and Anxiety, run by Ordu University.
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 2 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: opening soon, as of the sponsor's last update on 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
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 Hacer Gök Uğur, Asos. Prof. (+90 452 2265200 ext. 6432, hacer32@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Anxiety Inverntory (time frame: At the beginning of the study and end of 16 weeks treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2025.