Clinical trial NCT06841133: Chinese Art Activities or Combined With Peer Group Participation on Psychological Well Being
Official title: The Effectiveness of Chinese Art Activities Combined With Peer Group Participation on Psychological Well Being Among Newly Old Chinese of Elderly Center: Randomized Controlled Trail
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Aging
Keywords: Art Activity
Peer Group
psychological well-being
older
Lead sponsor: Prince of Songkla University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 90
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this trial is to evaluate the effects of two interventions : routine care plus Chinese Art Activities(+CAA) and routine care plus Chinese Art Activities combined with Peer Group Participation (+CAA+PGP) on psychological well-being, loneliness, happiness, relaxation, and salivary cortisol levels in elderly participants (aged 60-85, new residents with ≤1 year of stay). The main questions it aims to answer are:

* Does the +CAA intervention improve psychological well-being and related outcomes compared to routine care?
* Does the +CAA+PGP intervention provide additional benefits over +CAA alone? Researchers will compare three groups (Group A: +CAA, Group B: +CAA +PGP, Group C: routine care) to see if the interventions lead to immediate and sustained improvements in the measured outcomes.

Participants will:

* Undergo baseline assessments of psychological well-being(PWB), loneliness, happiness, relaxation, and salivary cortisol levels.
* Receive their assigned intervention over three sessions within one week (Monday, Wednesday, Friday).
* Complete outcome measures 30 minutes before and after each session.
* Participate in a final follow-up assessment one week after the last session to evaluate sustained effects.

Detailed description: This multi-center, randomized, assessor-blind trial is designed based on the Max.-Min.-Con. principle, which aims to maximize the benefits of the intervention while minimizing potential confounding factors and ensuring control over the study design. The trial features three parallel intervention groups: control (routine care), +CAA, and +CAA+PGP, with a 1:1:1 allocation ratio. This balanced allocation ensures that each intervention group and the control group have an equal number of participants, allowing for a fair comparison of outcomes.

The study is conducted sequentially across three elderly centers, with each center serving as an independent randomization unit. This multi-center approach enhances the generalizability of the findings by including diverse populations from different locations. Within each institution, 30 participants (aged 60-85, new residents with ≤1 year of stay) are recruited through health providers, totaling 90 elderly participants across all three centers. The inclusion of new residents (with ≤1 year of stay) is critical, as this population is particularly vulnerable to stress and reduced psychological well-being (PWB) during the transition to elderly care centers.

To ensure balanced groups and control for confounding variables, minimized randomization is employed. Within each institution, the 30 participants are divided into three groups-Group A, Group B, and Group C-with 10 participants in each group. Group A receives the +CAA intervention, Group B receives the +CAA+PGP intervention, and Group C serves as the control group, receiving only routine care. The use of minimized randomization helps to balance key confounding factors such as age and visitation frequency, ensuring that the groups are comparable at baseline.

The intervention is delivered over three sessions within one week, specifically on day 1, day 3 and day 5. This schedule allows for consistent exposure to the interventions while providing adequate time for participants to rest between sessions. The +CAA intervention involves traditional Chinese art activities, such as calligraphy and painting, which are designed to promote relaxation and emotional well-being. The +CAA+PGP intervention\*\* builds on this by incorporating peer group discussions, where participants share their experiences and artworks, fostering social interaction and mutual support.

Baseline assessments of key outcomes-psychological well-being (PWB), loneliness, happiness, relaxation, and salivary cortisol levels-are conducted prior to randomization. These baseline measures provide a reference point for evaluating the impact of the interventions. To capture the immediate effects of the interventions, outcome measures are collected 30 minutes before and after each intervention session. This allows the researchers to assess short-term changes in PWB, emotional states, and stress levels (as indicated by salivary cortisol).

Additionally, a final follow-up assessment is conducted one week after the last intervention session to evaluate the sustained outcomes of the interventions. This follow-up assessment is crucial for determining whether the benefits of the interventions persist beyond the immediate post-intervention period.

In summary, this trial is designed to rigorously evaluate the effectiveness of Chinese Art Activities (CAA) and their combination with Peer Group Participation (PGP) in improving psychological well-being and reducing stress among elderly residents transitioning to care centers. By employing a multicenter, randomized, and assessor-blind design, the study ensures robust and reliable results that can inform future interventions in elderly care settings.

Eligibility criteria: Inclusion Criteria:

* Age 60-85 years.
* Older persons living in Elderly Centers (ECs) for the first time, with a duration of stay ≤1 year.
* Normal cognitive function (Mini-Mental State Examination \[MMSE\] score \>24).
* Possess necessary reading and writing skills.
* Volunteer to participate in the study.

Exclusion Criteria:

* Older persons with serious diseases (e.g., heart failure, asthma, cerebrovascular disease, advanced tumors).
* Older persons who later leave the elderly center.

Primary outcomes:
measure: Change From Baseline in Psychological Well-Being (PWB) Score at End of Intervention
timeFrame: From enrollment to one week after the final intervention session
measure: Change From Baseline in Happiness Score at End of Intervention
timeFrame: From enrollment to one week after the final intervention session
measure: Change From Baseline in Relaxation Score at End of Intervention
timeFrame: From enrollment to one week after the final intervention session
measure: Change From Baseline in Loneliness Score at End of Intervention
timeFrame: From enrollment to one week after the final intervention session
measure: Change From Baseline in Salivary Cortisol Level at End of Intervention
timeFrame: From enrollment to one week after the final intervention session
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Sukangyang · Gaoxin Yiyang
state: Jiangsu
city: Suzhou
country: China
facility: Sukangyang · Jiangling
state: Jiangsu
city: Suzhou
country: China
facility: Sukangyang · Yiyang
state: Jiangsu
Study officials:
affiliation: Phd candidate of Faculty of Nursing Prince of Songkla University
name: Liping Pu
role: PRINCIPAL_INVESTIGATOR
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