- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06197230
The Effectiveness of Drawing Interventions
December 26, 2023 updated by: IRNA KARTINA, National Taipei University of Nursing and Health Sciences
The Effectiveness of Drawing Interventions on Depression Levels, Resourcefulness, and Spiritual Health of Older Adults in Nursing Homes
The study will consist of two stages.
The first stage of the study expects to find associations within dependent variables: depression level, resourcefulness, spiritual resourcefulness, and spiritual health in older adults.
The second stage estimated that art drawing interventions will be effective for improving depression levels, resourcefulness, spiritual resourcefulness, and spiritual health.
Study Overview
Detailed Description
A cross-sectional research design will be used in the first stage, and the second stage of the research will be an intervention and longitudinal study with a randomized control trial design.
In the first stage, four instruments will be applied, such as the Geriatric Depression Scale (GDS), Resourcefulness Scale (RS), Spiritual Resourcefulness Scale (SpRS), and Spiritual Screening Tool for Older Adults (SSTOA), to measure the levels of depression, resourcefulness, spiritual resourcefulness, and spiritual health of older adults at nursing homes in Indonesia.
Three hundred older adults will be recruited through purposive sampling in the first stage of the study, while 128 participants will be recruited and randomized and assigned to both the experimental and control groups.
There will be 64 subjects in each group.
The art drawing intervention will be applied and last for 6 weeks in the experimental group.
Five times of examinations about the related variables will be performed at the first week before intervention implemented (T0); the second measure will be performed 3 weeks after the intervention started (T1); 6 weeks of drawing intervention, the third examine will be tested (T2); and 1 and 2 months after the intervention completed, the participants will be asked to test for the T3 and T4
Study Type
Interventional
Enrollment (Estimated)
128
Phase
- 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 Contact
- Name: Irna Kartina, Master
- Phone Number: +886908493683
- Email: irnakartinakh@gmail.com
Study Contact Backup
- Name: Chien Yu Lai, AssProf
- Email: chienlai@ntunhs.edu.tw
Study Locations
-
-
D.I Yogyakarta
-
Bantul, D.I Yogyakarta, Indonesia, 55184
- Recruiting
- BPSTW Budi Luhur
-
Contact:
- KantorPSTW Budi Luhur
- Phone Number: +62274 - 895402
-
Principal Investigator:
- Irna Kartina
-
Yogyakarta, D.I Yogyakarta, Indonesia, 55582
- Recruiting
- Balai Pelayanan Sosial Tresna Wreda Unit Abiyoso
-
Contact:
- Fathoni
- Phone Number: +62274-895402
-
Principal Investigator:
- Irna Kartina, Master
-
-
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
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Currently live in nursing home
- Have no physical impairment.
- Have been staying in nursing home for at least 6 months.
- Speak Bahasa Indonesia
Exclusion Criteria:
- Have been diagnosed with psychiatric illness.
- Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention group ; Drawing Intervention
The intervention will be applied every week for 6 weeks.
The level of depression, resourcefulness, spiritual resourcefulness, and spiritual health will be tested at the first week before the intervention (T0), the 3rd week (T1), the 6th week right after the interventions (T2), 1 month follow-up after the interventions (T3), and 2 months post-intervention.
|
The primary sections of Drawing Intervention will be the "art-making" and "art-sharing" sections.
During the art-making segment, the group leader will guide the participants through a paper-warming exercise before assigning them a specific subject to draw freely for 20-30 minutes.
The leader will then ask participants to talk about the meaning of their artwork, encouraging them to explore their emotions regarding the theme and their drawing.
This procedure will be implemented in each segment of the intervention (6 sessions).
|
|
Other: Control
The control group will receive standard care in nursing home
|
The primary sections of Drawing Intervention will be the "art-making" and "art-sharing" sections.
During the art-making segment, the group leader will guide the participants through a paper-warming exercise before assigning them a specific subject to draw freely for 20-30 minutes.
The leader will then ask participants to talk about the meaning of their artwork, encouraging them to explore their emotions regarding the theme and their drawing.
This procedure will be implemented in each segment of the intervention (6 sessions).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Geriatry Depression Scale (GDS)
Time Frame: 14 weeks
|
Geriatric Depression Scale is one of depression scales known globally.
The Geriatric Depression Scale (GDS), developed by Yesavage et al. in 1983, is a self-report instrument consisting of 30 items.
|
14 weeks
|
|
Resourcefulness Scale
Time Frame: 14 weeks
|
The Resourcefulness Scale developed by Zauszniewski et al. (2006) will be used to test the degree of resourcefulness in older adults.
The scale consists of 28-items on a 6-point Likert-type scale
|
14 weeks
|
|
Spiritual Health/Spiritual Self-assessment index for older adult
Time Frame: 14 weeks
|
consists of 20 items, five measuring each of the constructs: (1) meaning and purpose, (2) hope and coping, (3) transcendence in relationships with God and others, and (4) religious practices.
This tool offers options to the participants with a degree of agreement for each item using a five-point Likert scale.
A numerical value will be assigned to each category: strongly disagree = 1, disagree = 2, uncertain = 3, agree = 4, and strongly agree = 5.
Item responses total score that could range from 20 to 100.
Higher scores indicated a greater degree of spiritual wellness.
Each of the four subscales consisted of five items, permitting a scoring range from 5 to 25. Items one through five, representing measuring hope and coping; six through ten will measure transcendence; eleven through fifteen for meaning and purpose; and sixteen through twenty focused on religious practices.
|
14 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Irna Kartina, National Taipei University of Nursing and Health Sciences
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)
November 23, 2023
Primary Completion (Estimated)
June 30, 2024
Study Completion (Estimated)
November 30, 2024
Study Registration Dates
First Submitted
December 26, 2023
First Submitted That Met QC Criteria
December 26, 2023
First Posted (Actual)
January 9, 2024
Study Record Updates
Last Update Posted (Actual)
January 9, 2024
Last Update Submitted That Met QC Criteria
December 26, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- NTUNHS_DI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Have not decided yet
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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