NCT04295083

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

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 3, 2020

Last Update Submit

March 3, 2020

Conditions

Keywords

clay therapypsychiatric nurselonelinesshopelessnesselderly

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

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.

Behavioral: clay based group study

Control group

NO INTERVENTION

The 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.

Experimental group

Eligibility Criteria

Age65 Years+
Sexall(Gender-based eligibility)
Gender Eligibility Details65 Years and older
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

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)

Location

Yasemin Kutlu

Istanbul, Turkey (Türkiye)

Location

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.

Study Officials

  • merve aydın

    Karadeniz Technical University

    PRINCIPAL INVESTIGATOR

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

Locations