- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06609408
The Effect of Nature and Game Based Activities on Older People
The Effect of Nature and Game Based Activities on Happiness, Spiritual Well-Being, Frailty and Cognitive Status of Older People in Nursing Home
The purpose of this study is determine the effect of nature and game based activities on happiness, spiritual well-being, frailty and cognitive status of older people in nursing home.
Hypotheses of the Research H0: Nature and game-based activities don't affect the happiness, spiritual well-being, cognitive function and frailty of older people in nursing home.
H1a: Happiness levels of older people in nursing home will be an increase after nature and game-based activities.
H1b: Spiritual well-being levels of older people in nursing home will be an increase after nature and game-based activities.
H1c: Cognitive function levels of older people in nursing home will be an increase after nature and game-based activities.
H1d: Frailty status of older people in nursing home will be a decrease after nature and game-based activities.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mürselcan Kabakcı, PhD.
- Phone Number: 537 561 5067
- Email: murselcan28@gmail.com
Study Contact Backup
- Name: İlknur Aydın Avci, Prof. Dr.
- Phone Number: 362 312 6341
- Email: ilknura@omu.edu.tr
Study Locations
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Atakum
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Samsun, Atakum, Turkey, 55200
- Ondokuz Mayıs University
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Contact:
- İlknur Aydın Avci, Prof. Dr.
- Phone Number: 362 312 6341
- Email: ilknura@omu.edu.tr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older people who have been in a nursing home for at least 6 months,
- Older people aged 65 years and over,
- Older people with a Mini Mental State score of 24 and above,
- Older people who are open to communication and co-operation will be included in the study.
Exclusion Criteria:
- Older people with physical problems that may prevent them from participating in nature and game based activities (such as stroke, Parkinson's),
- Older people with visual and hearing loss that may pose an obstacle to nature and game based activities,
- Older people with mental problems (such as dementia) that would prevent participation in nature and game based activities were excluded from the study.
Study Plan
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
Nature and game based activities will be applied to the participants in the experimental group once a week for 60 minutes for 8 weeks in this study.
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Individuals in experimental group will participate nature and game activities such as terrarium making, planting flowers, making puzzles in intervention.
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No Intervention: Control Group
Individuals in the control group will not participate in the intervention.
Individuals in control group will continue their routine activities in nursing home.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subjective Happiness Scale
Time Frame: This scale will be applied before and after the 8-week experiment.
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Subjective Happiness Scale was developed by Lyubomirsky and Lepper (1999) and adapted to Turkish by Akın and Satıcı (2011), and its validity and reliability were performed.
This scale consists of 4 items in total and has a 7-point Likert type.
The 4th item of the scale is reverse coded, and a total score is obtained by adding the scores of the items.
A minimum of 4 and a maximum of 28 points are obtained from the scale.
A high score from the scale indicates high perceived general subjective happiness, while a low score from the scale indicates low perceived subjective happiness.
Cronbach Alpha coefficient of the scale is 0.86 and test-retest reliability coefficient is 0.73.
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This scale will be applied before and after the 8-week experiment.
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Standardized Mini Mental State Examination
Time Frame: This scale will be applied before and after the 8 weeks experiment.
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Standardized Mini Mental State Examination was developed by Folstein et al. (1975) to be used in dementia screening and adapted into Turkish by Güngen et al. (2002) to assess cognitive status.
This scale is examined under five main headings and evaluated as recording memory (3 points), orientation (10 points), recall (3 points), attention and calculation (5 points) and language (9 points).
There are two separate forms of the Mini Mental State for educated and uneducated individuals.
The scale is evaluated out of 30 points; 24-30 is considered as normal, below 24 as cognitive impairment, 18-23 as mild dementia, 12-17 as moderate dementia and below 12 as severe dementia.
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This scale will be applied before and after the 8 weeks experiment.
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Tilburg Frailty Indicator
Time Frame: This scale will be applied before and after the 8-week experiment.
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Tilburg Frailty Indicator was developed by Gobbens et al. (2010) and adapted into Turkish and its validity and reliability was conducted by Arslan et al. (2018).
Tilburg Frailty Scale consists of two parts.
Part A includes 10 questions about diseases and sociodemographic factors that determine frailty; Part B consists of three factors that are components of frailty, including a total of 15 questions.
The score range varies between 0-15; 5 or more a high score point is considered as frailty in Tilburg Frailty Indicator.
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This scale will be applied before and after the 8-week experiment.
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Spiritual Well-Being Scale
Time Frame: This scale will be applied before and after the 8-week experiment.
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Spiritual Well-Being Scale was developed by Ekşi and Kardaş (2017) for adults in order to determine the process of understanding and living their lives in personal, social, environmental and trascendental aspects in line with human values and ultimate meanings.
The scale consists of 29 items and has a five-point Likert type.
Seven questions in the scale (3, 7, 11, 15, 19, 23 and 26) are calculated inversely.
The score that can be obtained from the scale is between 29-145.
The higher the score obtained from the scale, the higher the level of spiritual well-being.
Cronbach Alpha coefficient of the scale was found to be 0.886.
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This scale will be applied before and after the 8-week experiment.
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: İlknur Aydın Avci, Prof. Dr., Ondokuz Mayıs University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OMU-2024-744
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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