NCT06609408

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 24, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

June 12, 2025

Status Verified

September 1, 2024

Enrollment Period

5 months

First QC Date

September 22, 2024

Last Update Submit

June 11, 2025

Conditions

Keywords

NatureOlder PeopleNursing HomeHappinessSpiritual Well-BeingFrailtyCognition

Outcome Measures

Primary Outcomes (4)

  • Subjective Happiness Scale

    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.

    This scale will be applied before and after the 8-week experiment.

  • Standardized Mini Mental State Examination

    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.

    This scale will be applied before and after the 8 weeks experiment.

  • Tilburg Frailty Indicator

    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.

    This scale will be applied before and after the 8-week experiment.

  • Spiritual Well-Being Scale

    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.

    This scale will be applied before and after the 8-week experiment.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Nature and Game Based Activities

Control Group

NO INTERVENTION

Individuals in the control group will not participate in the intervention. Individuals in control group will continue their routine activities in nursing home.

Interventions

Individuals in experimental group will participate nature and game activities such as terrarium making, planting flowers, making puzzles in intervention.

Experimental Group

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • İlknur Aydın Avci, Prof. Dr.

    Ondokuz Mayıs University

    STUDY DIRECTOR

Central Study Contacts

Mürselcan Kabakcı, PhD.

CONTACT

İlknur Aydın Avci, Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single blind randomised controlled mixed method trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist Nurse (PhD.)

Study Record Dates

First Submitted

September 22, 2024

First Posted

September 24, 2024

Study Start

July 1, 2025

Primary Completion

December 1, 2025

Study Completion

May 1, 2026

Last Updated

June 12, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations