Effect of Clay Based Group Study With Elderly Living Alone
The Effect of Clay Based Group Study on the Loneliness and Hopelesness Levels in Elderly Living Alone: Randomized Controlled Study
1 other identifier
interventional
60
1 country
2
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Dec 2017
Typical duration for not_applicable
2 active sites
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
Study Start
First participant enrolled
December 27, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 27, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2019
CompletedFirst Submitted
Initial submission to the registry
March 3, 2020
CompletedFirst Posted
Study publicly available on registry
March 4, 2020
CompletedMarch 5, 2020
March 1, 2020
11 months
March 3, 2020
March 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Measurement of Loneliness
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.
6 weeks
Measurement of Hopelessness
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.
6 weeks
Study Arms (2)
Experimental group
EXPERIMENTALThe experimental group will be six 1,5 h weekly of clay based group study and interviewed face-to-face twice by the researchers.
Control group
NO INTERVENTIONThe control group will interviewed face-to-face twice
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Merve Aydın
Trabzon, Karadeniz Technical University, 61800, Turkey (Türkiye)
Yasemin Kutlu
Istanbul, Turkey (Türkiye)
Related Publications (1)
Aydin M, Kutlu FY. The Effect of Group Art Therapy on Loneliness and Hopelessness Levels of Older Adults Living Alone: A Randomized Controlled Study. Florence Nightingale J Nurs. 2021 Oct;29(3):271-284. doi: 10.5152/FNJN.2021.20224.
PMID: 35110167DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
merve aydın
Karadeniz Technical University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Without knowing that participants are in the experimental or control group
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 3, 2020
First Posted
March 4, 2020
Study Start
December 27, 2017
Primary Completion
November 27, 2018
Study Completion
December 12, 2019
Last Updated
March 5, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share
There is no plan to share to IPD