ARTNCT04295083
Effect of Clay Based Group Study With Elderly Living Alone
A study testing clay based group study in people with ART, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- ART
- What is being tested?
- clay based group study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 27 Dec 2017to 12 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Yasemin Kutlu
Istanbul
Merve Aydın
Trabzon, Karadeniz Technical University, 61800
About this study
Official title: 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
Read the 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.
- Conditions
- ART
- Being tested
- clay based group study
- Keywords
- clay therapy, psychiatric nurse, loneliness, hopelessness, elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clay based group studyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The experimental group will be six 1,5 h weekly of clay based group study and interviewed face-to-face twice by the researchers. Receives: Behavioral: clay based group study |
| Control group | No intervention | The control group will interviewed face-to-face twice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start27 Dec 2017
- Primary completion27 Nov 2018
- Study completion12 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARTStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Aydın, Karadeniz Technical University
- Investigators
- merve aydın, Principal investigator, Karadeniz Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295083
- Sponsor's protocol ID
- Nurse_Psychiatric61
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to share to IPD
Publications
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.
PubMed 35110167
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Clay Based Group Study on the Loneliness and Hopelesness Levels in Elderly Living Alone: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04295083
- Acronym / sponsor ID
- Nurse_Psychiatric61
- Conditions
- ART
- Keywords
- clay therapy, psychiatric nurse, loneliness, hopelessness, elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 27 Nov 2018 (actual)
- Study completion
- 12 Dec 2019 (actual)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: clay based group studyThe 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 intervention | –The control group will interviewed face-to-face twice |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clay based group studyClay 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. | Behavioural | Experimental group |
Primary outcome
Measurement of Loneliness
Time frame: 6 weeks
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.
Measurement of Hopelessness
Time frame: 6 weeks
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 35110167Aydin 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.
- Individual participant dataSharing planned: No. There is no plan to share to IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
merve aydın principal investigator
Karadeniz Technical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clay based group study in people with ART, run by Karadeniz Technical University at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Loneliness (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04295083, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2020.