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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Turkey
      • Istanbul, Turkey
        • Yasemin Kutlu
    • Karadeniz Technical University
      • Trabzon, Karadeniz Technical University, Turkey, 61800
        • Merve Aydın

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Behavioral: clay based group study
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.
No Intervention: Control group
The control group will interviewed face-to-face twice

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 weeks
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Karadeniz Technical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 27, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 4, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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