Chinese Art Activities or Combined With Peer Group Participation on Psychological Well Being (CAA+PGP#PWB)

July 1, 2025 updated by: Liping Pu, Prince of Songkla University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

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

Study Contact Backup

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Sukangyang · Gaoxin Yiyang
        • Contact:
      • Suzhou, Jiangsu, China, 215000
        • Sukangyang · Jiangling
        • Contact:
      • Suzhou, Jiangsu, China, 215000
        • Sukangyang · Yiyang
        • Contact:

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chinese Art Activities (CAA)
Participants will receive routine care plus the CAA intervention. The intervention is delivered over three sessions within one week (day1,3,5), with each session lasting 50 minutes.Baseline measures are collected pre-randomization. Outcomes are assessed 30 minutes before and after each intervention session . A final follow-up assessment is conducted one week after the last intervention.
Behavioral: Chinese Art Activities

This activity based on Recreation therapy, aims to heal the psychological symptom cluster and enhance the PWB of the old Chinese transit to the elderly center. The activity follows the usual care during the process with the addition of Chinese art activities. It employed the following two main activities:

(1) Traditional Chinese landscape painting; (2) Calligraphy. The activity will be conducted 50min by researchers. It can be conducted at hall, conference room, etc. in the elderly center (EC), and it is a group intervention
Experimental: Chinese Art Activities combined with Peer Group Participation (PGP)
Participants will receive routine care plus the CAA and PGP intervention. The intervention is delivered over three sessions within one week (day1,3,5), with each session lasting 80 minutes.Baseline measures are collected pre-randomization. Outcomes are assessed 30 minutes before and after each intervention session . A final follow-up assessment is conducted one week after the last intervention
Behavioral: Chinese Art Activities combined with Peer Group Participation (PGP)
The activity follows the usual care during the process with the addition of Chinese art activities combined with Peer Group Participation. The activity will be conducted 80min by researchers. In groups of 5 people, after the painting and calligraphy activity, under the organization of peers, each group member will show their works and talk about their feelings and views on their works. They will also share the reasons why they chose these words or sentences. Everyone must say words of comfort and encouragement to others' work.
No Intervention: routine care
Participants in both the intervention and control groups will receive identical routine care, including daily activities such as simple limb exercises and group walks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Psychological Well-Being (PWB) Score at End of Intervention
Time Frame: From enrollment to one week after the final intervention session
Psychological well-being was assessed using the 18-item Chinese version of Ryff's Psychological Well-Being Scale. This scale measures six dimensions of well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Each item is scored on a 6-point Likert scale (1=strongly disagree, 6=strongly agree). The total score ranges from 18 to 108, with higher scores indicating better psychological well-being.
From enrollment to one week after the final intervention session
Change From Baseline in Happiness Score at End of Intervention
Time Frame: From enrollment to one week after the final intervention session
Happiness was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of happiness on a horizontal line, where 0 mm represents "not happy at all" and 100 mm represents "extremely happy." The VAS is a widely used tool for assessing subjective feelings, and higher scores indicate greater happiness.
From enrollment to one week after the final intervention session
Change From Baseline in Relaxation Score at End of Intervention
Time Frame: From enrollment to one week after the final intervention session
Relaxation was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of relaxation on a horizontal line, where 0 mm represents "not relaxed at all" and 100 mm represents "extremely relaxed." The VAS is a validated tool for assessing subjective states, and higher scores indicate greater relaxation.
From enrollment to one week after the final intervention session
Change From Baseline in Loneliness Score at End of Intervention
Time Frame: From enrollment to one week after the final intervention session
Loneliness was measured using a 100 mm Visual Analog Scale (VAS). Participants were asked to mark their current level of loneliness on a horizontal line, where 0 mm represents "extremely lonely" and 100 mm represents "not lonely at all." The VAS is a reliable tool for assessing subjective feelings, and higher scores indicate lower loneliness.
From enrollment to one week after the final intervention session
Change From Baseline in Salivary Cortisol Level at End of Intervention
Time Frame: From enrollment to one week after the final intervention session
Salivary cortisol levels were measured as an indicator of stress response. Participants provided saliva samples, which were analyzed in a specialized laboratory using enzyme-linked immunosorbent assay (ELISA) techniques. Cortisol levels are reported in nmol/L, and higher values may indicate higher stress levels. This method is non-invasive and widely used in stress-related research.
From enrollment to one week after the final intervention session

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prince of Songkla University

Investigators

  • Principal Investigator: Liping Pu, Phd candidate of Faculty of Nursing Prince of Songkla University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

July 9, 2025

Primary Completion (Estimated)

July 19, 2025

Study Completion (Estimated)

August 9, 2025

Study Registration Dates

First Submitted

February 8, 2025

First Submitted That Met QC Criteria

February 19, 2025

First Posted (Actual)

February 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 3, 2025

Last Update Submitted That Met QC Criteria

July 1, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PSU IRB 2024-St-Nur 048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The corresponding author's contact details will be publicly available for researchers to contact the investigators. Data are available upon written request, in accordance with the General Data Protection Regulation (GDPR)

IPD Sharing Time Frame

After finishing the research

IPD Sharing Access Criteria

Data are available upon written request, in accordance with the General Data Protection Regulation (GDPR)

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

Clinical Trials on Aging

Clinical Trials on Chinese Art Activities

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gabon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe