NCT05724147

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 27, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

March 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

2 months

First QC Date

January 27, 2023

Last Update Submit

February 10, 2023

Conditions

Keywords

MandalaOlderElderlyHappinessWell-being

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    5 week

Study Arms (1)

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).

Behavioral: Mandala Activity

Interventions

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.

Mandala Activity

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Şeyma Demiralay

Istanbul, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: in a single group pretest-posttest research design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2023

First Posted

February 13, 2023

Study Start

March 15, 2023

Primary Completion

May 15, 2023

Study Completion

May 15, 2023

Last Updated

February 13, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

I can share to contribute to the literature

Time Frame
6 months

Locations