- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05576558
The Effect of Occupational Therapy on Anxiety, Depression, and Psychological Well-Being Symptoms in the Elderly: A Single-Blind Randomized-Controlled Study
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
Study Overview
Status
Detailed Description
Participants were assigned to intervention and control groups according to the randomization list previously prepared by the researchers. All participants were first informed about the study and their informed consent was obtained. Participant Information Form, Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were filled out by all participants.
The elderly in the intervention group were divided into 5 groups of 10 and a time was determined for the session in cooperation with the participants in each subgroup. A 60-minute therapy session was administered by the occupational expert. The applications were carried out in a total of 7 sessions as a daily session. The control group was not subjected to any application. Geriatric Anxiety Scale, Psychological Well-Being Scale, and Geriatric Depression Scale were refilled for the second time in all elderly on the 7th day after the application.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey
- Seda Değirmenci Öz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
This study was carried out between April and August 2022 with the elderly living in a private elderly care center in Istanbul/Turkey.
The elderly, who agreed to participate in the study, were aged 60 and over, were cooperative, had no communication problems, and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Description
Inclusion Criteria:
- The elderly, who agreed to participate in the study,
- were aged 60 and over, were cooperative,
- had no communication problems,
- and did not receive any training, course, or practice on coping with anxiety, tension, and stress were included in the sample.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Participant Information Form
Time Frame: From April to August 2022
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It was created in line with the literature.
It is a form containing sociodemographic data such as age, gender, educational status, etc.
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From April to August 2022
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Geriatric Anxiety Scale:
Time Frame: From April to August 2022
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It is a measurement tool that consists of 28 items and provides self-anxiety reporting of the elderly.
The scale was developed by Pachana et al. (Pachana et al., 2007), and adapted to the Turkish language by Karahan et al. (Karahan et al., 2018).
Participants were asked to indicate how often they experienced each symptom during the week including today.
The response format uses a 4-point Likert scale ranging from 0 (never) to 3 (always), with higher scores indicating higher levels of anxiety.
The scale covers three different subscales common among older adults.
These are somatic (physical) subscale, 1, 6, 7, 15, 19, 20, 21 (7 items), cognitive symptoms 2, 3, 10, 14, 16, 17, 22, 23 (8 items), and mood subscale, 4, 5, 8, 9, 11, 12, 13, 18 (8 items).
The GAS total score is based on the first 23 items.
Since items 24-28 are used by clinicians to determine the area of anxiety, they are not used in total scoring.
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From April to August 2022
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Psychological Well-Being Scale
Time Frame: From April to August 2022
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The scale developed by Diener, Scollon, & Lucas, (2009) to measure the level of psychological well-being has eight items.
It identifies important elements of human function, including positive relationships, feeling of efficacy, and having a meaningful and purposeful life.
The Turkish validity and reliability of the scale were made by Telef in 2013.
Scale items are scored between 1 (strongly disagree) and 7 (strongly agree).
All items are structured positively.
Scores range from 8 (strongly disagree with all items) to 56 (strongly agree with all items).
A high score on the scale indicates a high psychological strength of the individual.
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From April to August 2022
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Geriatric Depression Scale
Time Frame: From April to August 2022
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It was developed by Yesavage to evaluate the depressive symptoms of elderly individuals and consists of a total of 15 questions (Yesavage & Sheikh, 1986).
It is designed in such a way that the elderly can mark it easily and can be answered as "yes" or "no".
Items 1, 5, 7, 11, and 13 in the scale are structured positively, while other items are structured negatively.
In the scoring of the scale, 1 point is given for each response in favor of depression and 0 points for other responses.
A score of "5 and above" on the scale is considered a significant finding for the diagnosis of depression (Akturk, Sahin, Dagdeviren & Ozer, 2002).
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From April to August 2022
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: SEDA DEĞİRMENCİ ÖZ, Dr., İstanbul Aydın University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- Istanbul AU
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
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