Mandala Activity in Elderly People Living in Nursing Homes

February 10, 2023 updated by: Atlas University

The Effect of Mandala Activity on Happiness and Well-Being Levels in Elderly People Living in Nursing Homes: Colorize Life Project

The Effect of Mandala Activity on Happiness and Well-Being Levels in Elderly People Living in Nursing Homes: Colorize Life Project

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

In recent years, there has been a global increase in the elderly population. Biopsychosocial regressions and various health problems are seen in the elderly, and their care and follow-up mostly continue with hospitalization in nursing homes. In studies examining the opinions of elderly individuals staying in nursing homes about the institution they stay, it has been stated that individuals see the institution as an area for making friends and socializing with their peers. In Erikson's theory of psychosocial development, it is stated that in the last stage of old age, individuals experience hopelessness against self-integrity. If his evaluation of his life is positive, self-integrity is achieved, if it is negative, he falls into despair, experiences dissatisfaction and becomes unhappy. In this context, various psychosocial interventions are recommended within the scope of protecting and improving mental health in elderly individuals. In the literature, when the studies using mandala were examined, it was found that the effects of the effects on the children and adolescent groups and the effects on the anxiety levels were mostly evaluated. In the international literature, studies evaluating the effect of mandala activity with elderly individuals are limited, and in our country, no study with this sample has been found. This study is unique in terms of evaluating the effect of mandala activity on elderly individuals living in nursing homes in our country. It is a multi-faceted study since the study is carried out with undergraduate students, it is carried out with students from the psychology and nursing departments, as a multidisciplinary, and it will implement the planned activity with elderly individuals who are hospitalized in a nursing home. At the end of the study, it is predicted that the elderly individuals will increase their happiness and well-being. Undergraduate students taking part in the study will also experience doing an experimental study. When considered in the context of Erikson's psychosocial development theory, it is thought that it is important to support the elderly individuals psychosocially in old age, which is the last stage of life. The study is an experimental study designed in a pretest and posttest pattern. The universe of the study; All nursing homes (n=12) in Şişli district will consist of elderly individuals receiving health care services. In the selection of the sample, first of all, the institution where the study will be carried out will be determined by drawing lots among the institutions, and the elderly individuals who meet the inclusion and exclusion criteria will form the sample of the study. Data will be obtained with Personal Information Form (PIF), Happiness Scale and Well-Being Scale. There will be a total of 5 sessions, including the Mandala activity once a week, meeting (1), working (3) and ending (1). In the study, answers will be sought to the question "Is there a difference between the happiness and well-being levels of individuals before and after the Mandala activity?" The analysis of the data will be done using the SPSS 23.0 package program. In the evaluation of the data, descriptive statistics such as frequency distribution, mean and standard deviation will be used to define the sample, two-pair test or Wilcoxon peer test will be used according to the parametric test assumptions for the comparison of the group within itself, and the Chi-square test will be used for the analysis of categorical data. 95% significance level will be used to determine the differences in the analyses. The answers to the open-ended questions will be categorized by the researchers and evaluated as numbers and percentages. As a result of the study, the effect of mandala activity on the happiness and well-being of the elderly will be determined and a contribution will be made to the literature. It is envisaged that the mandala activity applied in this study will guide further studies. In line with the literature information and justification, this study was planned to determine the effect of mandala activity on happiness and well-being levels in elderly individuals living in nursing homes.

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 (Anticipated)

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.
35

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
        • Şeyma Demiralay

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

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Being 60 years or older
  • Do not speak Turkish
  • Continuing hospitalization in the specified institution,
  • Ability to hold pencils, draw, paint,
  • Not having any neurological and physical disorders (paralysis, rheumatoid arthritis, etc.) in their hands,
  • Volunteering to participate in the study

Exclusion Criteria:

  • Having a barrier to communication,
  • Having a diagnosis of any mental disorder,

Removal Criteria:

  • Not attending 2 sessions or more, The development of a medical condition that hinders the intervention process,
  • Leaving the institution,
  • The participant's right to withdraw from the research at his/her own request or family

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: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

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: Mandala Activity
There will be a total of 5 sessions, including the Mandala activity once a week, meeting (1), working (3) and ending (1).
Behavioral: Mandala Activity
Three sessions of mandala activity, once a week, will be applied to the participants from the elderly people in the nursing home included in the study. The mandala activity planned to be done with the group will be done in addition to the standard monitoring applied in the institution, so it will be held at an appropriate time according to the flow in the institution. Before leaving the individuals, the most appropriate time for the next mandala session will be determined by taking into account the preferences of the individuals. Individuals to be included in the study will be grouped in groups of 10. Mandala activity application time is planned to last approximately 2 hours. If individuals have any physical symptoms, the time of the mandala activity is rescheduled, and each individual is expected to attend five sessions during the total study period.

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
Happiness
Time Frame: 5 week
Happiness Scale. It consists of six five-point Likert-type questions: (1) Not at all suitable for me (2) Not suitable for me (3) Somewhat suitable for me (4) Fairly suitable for me (5) Completely suitable for me. The scores that can be obtained from the scale are between 6-30. The higher the score, the higher the happiness level.
5 week
Well-Being
Time Frame: 5 week
Well-Being Scale. Participants are expected to express their opinions on the scale items on a 7-point Likert-type rating, ranging from 1-strongly disagree to 7-strongly agree. A total well-being score can be obtained by summing the scores of all items in the scale. The highest score that can be obtained from the scale is 56, and the lowest score is 8. There is no reverse scored item in the scale. High scores obtained from the scale indicate that the level of well-being of the individual is high.
5 week

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.
Atlas University

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 (ANTICIPATED)

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.
March 15, 2023

Primary Completion (ANTICIPATED)

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.
May 15, 2023

Study Completion (ANTICIPATED)

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.
May 15, 2023

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).
January 27, 2023

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.
February 10, 2023

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.
February 13, 2023

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.
February 13, 2023

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.
February 10, 2023

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.
February 1, 2023

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.
  • AtlasU3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

I can share to contribute to the literature

IPD Sharing Time Frame

6 months

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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