- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04295083
Effect of Clay Based Group Study With Elderly Living Alone
March 3, 2020 updated by: Merve Aydın, Karadeniz Technical University
The Effect of Clay Based Group Study on the Loneliness and Hopelesness Levels in Elderly Living Alone: Randomized Controlled Study
This study determines the effectiveness of clay-based group study on the loneliness and hopelessness levels in elderly living alone.
For this, while the experimental group will six 1,5 h weekly of clay-based group study and interviewed face-to-face twice, the control group will interview face-to-face twice
Study Overview
Detailed Description
One of the most important social changes today is the aging of the world's population.
Along with the increasing elderly population, there is a serious increase in the number of elderly living alone.
Many problems such as living alone, despair, insecurity, fear, depression, future anxiety, and close relationship longing are seen in the elderly who constitute the risk group in terms of mental health.
The communication, social life and support opportunities of the elderly living alone with other people, their environment, relatives, and society are decreasing.
Today, loneliness is one of the most commonly experienced psychological symptoms among the elderly.
It has been reported that the feeling of loneliness is 80.0% in individuals aged 65 and over, and the age when this feeling is most common is 70 and above.
Another of the most common emotions in the elderly is hopelessness.
It is recommended to use art therapy, which is a supportive method suitable for a biopsychosocial approach in coping with loneliness and hopelessness.
The art type, technique, and materials to be used in art therapy should be compatible with the age, ability, mental and physical development of the person to be applied.
It is a substance that can be manipulated and deformed many times due to its clay structure.
The person doing the clay works without fear of damaging the object due to the plastic and durable structure of the clay.
Due to its advantage of being able to do it comfortably, it is a suitable art form for elderly individuals who are in the period of neurocognitive decline.
Under this scope, this study will evaluate the effect of clay-based group study on the loneliness and hopelessness levels in elderly living alone.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- 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 Locations
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Istanbul, Turkey
- Yasemin Kutlu
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Karadeniz Technical University
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Trabzon, Karadeniz Technical University, Turkey, 61800
- Merve Aydın
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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
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Older than 65 years and old,
- To get a score of 19 and above on the Mini-Mental Status examination scale,
- Scoring less than 30 on the Beck Depression scale,
- To score 32 and above on UCLA-LS Loneliness scale,
- To get 4 points or more from the Beck Hopelessness Scale,
- Volunteering to participate in the research
Exclusion Criteria:
- Having a perception disorder that will prevent communication,
- Having a neurological and physical discomfort (paralysis, rheumatoid arthritis, etc.) in their hands,
- Having been diagnosed with any mental disorder
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: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Experimental group
The experimental group will be six 1,5 h weekly of clay based group study and interviewed face-to-face twice by the researchers.
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Clay based group work sessions were applied to the experimental group for 60-90 minutes once a week for 6 weeks.
The sessions are composed of structured or semi-structured activities prepared for the purpose of the literature by the researcher for the purposes such as acquiring new solutions and life skills to reduce loneliness and hopelessness of individuals aged 65 and over, and sharing their feelings, thoughts, and memories with other individuals.
Clay Study Activity Booklet ".
Four expert opinions were obtained for the booklet created.
Methods such as narration, sharing experiences, group practice, question-answer, learning by doing, imagining were used in the activity program.
The physical, psychological, social and mental characteristics of the elderly were taken into consideration in the selection of these methods.
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No Intervention: Control group
The control group will interviewed face-to-face twice
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Measurement of Loneliness
Time Frame: 6 weeks
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At the end of 6 weeks (6 sessions of clay work + 2 sessions face to face interview), they will be evaluated using the UCLA-LS Loneliness Scale.
The highest score that can be obtained from the scale is 80, and the lowest score is 20.
High scores show that individuals experience more loneliness.
20-31 score range "No loneliness", 32-41 score range "Very mild loneliness", 42-53 score range "Slight loneliness", 54-67 score range "Lonely" and 68-80 score range is classified as "Totally lonely".
The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
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6 weeks
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Measurement of Hopelessness
Time Frame: 6 weeks
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At the end of 6 weeks (6 sessions of clay work + 2 sessions face to face interviews) will be evaluated using the Beck Hopelessness Scale.
The highest score that can be obtained from the scale is 20, and the lowest score is 1.
When the scores are high, the hopelessness of the individual is assumed to be high.
0-3 points of hopelessness, 4-8 points of low hopelessness, 9-14 points of medium hopelessness and 15-20 points of high hopelessness were stated.
It is stated that it can be used to predict suicide for scores of 9 and above.
The minimum, maximum, median, 25th and 75th quartile were evaluated for each group and compared between the groups.
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6 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: merve aydın, Karadeniz Technical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
December 27, 2017
Primary Completion (Actual)
November 27, 2018
Study Completion (Actual)
December 12, 2019
Study Registration Dates
First Submitted
March 3, 2020
First Submitted That Met QC Criteria
March 3, 2020
First Posted (Actual)
March 4, 2020
Study Record Updates
Last Update Posted (Actual)
March 5, 2020
Last Update Submitted That Met QC Criteria
March 3, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Nurse_Psychiatric61
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
There is no plan to share to IPD
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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