HappinessNCT05724147
Mandala Activity in Elderly People Living in Nursing Homes
A study testing Mandala Activity in people with Happiness and Well-being, run by Atlas University at 1 site in Turkey (Türkiye).
Trial summary
The Effect of Mandala Activity on Happiness and Well-Being Levels in Elderly People Living in Nursing Homes: Colorize Life Project Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Happiness, Well-being, Older
- What is being tested?
- Mandala Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2023to 15 May 2023
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Happiness, Well-being, Older, Elderly
- Being tested
- Mandala Activity
- Keywords
- Mandala, Older, Elderly, Happiness, Well-being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandala ActivityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mandala Activity | Experimental | There will be a total of 5 sessions, including the Mandala activity once a week, meeting (1), working (3) and ending (1). Receives: Behavioral: Mandala Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Happiness
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.
Measured: 5 week
Well-Being
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.
Measured: 5 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Mar 2023 (estimated)
- Primary completion15 May 2023 (estimated)
- Study completion15 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HappinessStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- in a single group pretest-posttest research design
- Masking
- None (open label)
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atlas University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05724147
- Sponsor's protocol ID
- AtlasU3
- Status last verified
- Feb 2023
- First submitted
- 27 Jan 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: I can share to contribute to the literature
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mandala Activity on Happiness and Well-Being Levels in Elderly People Living in Nursing Homes: Colorize Life Project
- ClinicalTrials.gov ID
- NCT05724147
- Acronym / sponsor ID
- AtlasU3
- Conditions
- Happiness, Well-being, Older, Elderly
- Keywords
- Mandala, Older, Elderly, Happiness, Well-being
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Atlas UniversityUniversity, hospital or other
- Study start
- 15 Mar 2023 (estimated)
- Primary completion
- 15 May 2023 (estimated)
- Study completion
- 15 May 2023 (estimated)
- First posted
- 13 Feb 2023 (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.
The Effect of Mandala Activity on Happiness and Well-Being Levels in Elderly People Living in Nursing Homes: Colorize Life Project
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- in a single group pretest-posttest research design
| Arm | Type | Receives |
|---|---|---|
| Mandala Activity | Experimental | Behavioral: Mandala ActivityThere will be a total of 5 sessions, including the Mandala activity once a week, meeting (1), working (3) and ending (1). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (6 listed)
- Having a barrier to communication,
- Having a diagnosis of any mental disorder,
- 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
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 |
|---|---|---|
| Mandala ActivityThree 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. | Behavioural | Mandala Activity |
Primary outcome
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2023.
- Individual participant dataSharing planned: Yes. I can share to contribute to the literature
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandala Activity in people with Happiness and Well-being, run by Atlas University at 1 site 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 6 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: status not confirmed, as of the sponsor's last update on 13 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Happiness (time frame: 5 week). 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?
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 13 Feb 2023.