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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06197230
Other study ID # NTUNHS_DI
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 23, 2023
Est. completion date November 30, 2024

Study information

Verified date December 2023
Source National Taipei University of Nursing and Health Sciences
Contact Irna Kartina, Master
Phone +886908493683
Email irnakartinakh@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The second stage estimated that art drawing interventions will be effective for improving depression levels, resourcefulness, spiritual resourcefulness, and spiritual health.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 128
Est. completion date November 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: 1. Currently live in nursing home 2. Have no physical impairment. 3. Have been staying in nursing home for at least 6 months. 4. Speak Bahasa Indonesia Exclusion Criteria: 1. Have been diagnosed with psychiatric illness. 2. Have been diagnosed with severe physical disorders such as advanced cancer or motor impairments

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Drawing 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).

Locations

Country Name City State
Indonesia BPSTW Budi Luhur Bantul D.I Yogyakarta
Indonesia Balai Pelayanan Sosial Tresna Wreda Unit Abiyoso Yogyakarta D.I Yogyakarta

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Indonesia, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 14 weeks
Primary 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 14 weeks
Primary 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. 14 weeks
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