Older AdultNCT06197230
The Effectiveness of Drawing Interventions
A study testing Drawing Intervention in people with Older Adult, run by National Taipei University of Nursing and Health Sciences at 2 sites in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adult
- What is being tested?
- Drawing Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 2 sitesIndonesia
- Study dates
- 23 Nov 2023to 30 Nov 2024
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Currently live in nursing home
- Have no physical impairment.
- Have been staying in nursing home for at least 6 months.
- Speak Bahasa Indonesia
Who cannot join
- Have been diagnosed with psychiatric illness.
- Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments
Trial locations and contacts
2 sites in 1 country.
Chien Yu Lai, AssProf contact
Indonesia2 sites, 2 recruiting
- Recruiting
BPSTW Budi Luhur
Bantul, D.I Yogyakarta, 55184
KantorPSTW Budi Luhur, +62274 - 895402
Irna Kartina
- Recruiting
Balai Pelayanan Sosial Tresna Wreda Unit Abiyoso
Yogyakarta, D.I Yogyakarta, 55582
Fathoni, +62274-895402
Irna Kartina, Master
About this study
Official title: 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.
Read the 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
- Conditions
- Older Adult
- Being tested
- Drawing Intervention
- Keywords
- Drawing Interventions, Depression, Resourcefulness, Spiritual Health, Older Adults
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drawing InterventionOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention group ; Drawing Intervention | Experimental | 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. Receives: Other: Drawing Intervention |
| Control | Other | The control group will receive standard care in nursing home Receives: Other: Drawing Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatry Depression Scale (GDS)
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.
Measured: 14 weeks
Resourcefulness Scale
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
Measured: 14 weeks
Spiritual Health/Spiritual Self-assessment index for older adult
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.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start23 Nov 2023
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial with longitudinal design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IRNA KARTINA, National Taipei University of Nursing and Health Sciences
- Investigators
- Irna Kartina, Principal investigator, National Taipei University of Nursing and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197230
- Sponsor's protocol ID
- NTUNHS_DI
- Status last verified
- Dec 2023
- First submitted
- 26 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Have not decided yet
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Drawing Interventions on Depression Levels, Resourcefulness, and Spiritual Health of Older Adults in Nursing Homes
- ClinicalTrials.gov ID
- NCT06197230
- Acronym / sponsor ID
- NTUNHS_DI
- Conditions
- Older Adult
- Keywords
- Drawing Interventions, Depression, Resourcefulness, Spiritual Health, Older Adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 23 Nov 2023 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 9 Jan 2024 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized control trial with longitudinal design
| Arm | Type | Receives |
|---|---|---|
| Intervention group ; Drawing Intervention | Experimental | Other: Drawing InterventionThe 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. |
| Control | Other | Other: Drawing InterventionThe control group will receive standard care in nursing home |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Currently live in nursing home
- Have no physical impairment.
- Have been staying in nursing home for at least 6 months.
- Speak Bahasa Indonesia
Key exclusion criteria (2 listed)
- Have been diagnosed with psychiatric illness.
- Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments
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 |
|---|---|---|
| Drawing InterventionThe 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, Intervention group ; Drawing Intervention |
Primary outcome
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.
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
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided. Have not decided yet
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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.
Chien Yu Lai, AssProf contact
Irna Kartina principal investigator
National Taipei University of Nursing and Health Sciences
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drawing Intervention in people with Older Adult, run by National Taipei University of Nursing and Health Sciences at 2 sites in Indonesia.
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 4 inclusion and 2 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 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. 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?
Contact Irna Kartina, Master (+886908493683, irnakartinakh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatry Depression Scale (GDS) (time frame: 14 weeks). The study lists 3 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 9 Jan 2024.