Biopsychosocial Effects of Gardening Activities

February 19, 2025 updated by: Hacer Gok Ugur, T.C. ORDU ÜNİVERSİTESİ

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

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 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 (Estimated)

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.
42

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Hacer Gök Uğur, Asos. Prof.
  • Phone Number: 6432 +90 452 2265200
  • Email: hacer32@gmail.com

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

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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
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.
Other: Gardening Activity
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.
No Intervention: Control Group
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 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
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.
At the beginning of the study and end of 16 weeks treatment
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.
At the beginning of the study and end of 16 weeks treatment
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
At the beginning of the study and end of 16 weeks treatment
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.
At the beginning of the study and end of 16 weeks treatment

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.
T.C. ORDU ÜNİVERSİTESİ

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 (Estimated)

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.
March 3, 2025

Primary Completion (Estimated)

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.
July 1, 2025

Study Completion (Estimated)

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.
August 1, 2025

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).
February 19, 2025

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.
February 19, 2025

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.
March 25, 2025

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.
March 25, 2025

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.
February 19, 2025

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.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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.
  • OrduBAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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