NCT06841133

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
5 months until next milestone

Study Start

First participant enrolled

July 9, 2025

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 19, 2025

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 9, 2025

Completed
Last Updated

July 3, 2025

Status Verified

February 1, 2025

Enrollment Period

10 days

First QC Date

February 8, 2025

Last Update Submit

July 1, 2025

Conditions

Keywords

Art ActivityPeer Grouppsychological well-beingolder

Outcome Measures

Primary Outcomes (5)

  • Change From Baseline in Psychological Well-Being (PWB) Score at End of Intervention

    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

    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

    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

    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

    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

Study Arms (3)

Chinese Art Activities (CAA)

EXPERIMENTAL

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

Chinese Art Activities combined with Peer Group Participation (PGP)

EXPERIMENTAL

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)

routine care

NO INTERVENTION

Participants in both the intervention and control groups will receive identical routine care, including daily activities such as simple limb exercises and group walks.

Interventions

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

Chinese Art Activities (CAA)

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.

Chinese Art Activities combined with Peer Group Participation (PGP)

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Sukangyang · Gaoxin Yiyang

Suzhou, Jiangsu, 215000, China

Location

Sukangyang · Jiangling

Suzhou, Jiangsu, 215000, China

Location

Sukangyang · Yiyang

Suzhou, Jiangsu, 215000, China

Location

Related Publications (11)

  • Aydin M, Kutlu FY. The Effect of Group Art Therapy on Loneliness and Hopelessness Levels of Older Adults Living Alone: A Randomized Controlled Study. Florence Nightingale J Nurs. 2021 Oct;29(3):271-284. doi: 10.5152/FNJN.2021.20224.

    PMID: 35110167BACKGROUND
  • Bourdon E, Belmin J. Enriched gardens improve cognition and independence of nursing home residents with dementia: a pilot controlled trial. Alzheimers Res Ther. 2021 Jun 16;13(1):116. doi: 10.1186/s13195-021-00849-w.

    PMID: 34134758BACKGROUND
  • Ellis JM. Psychological transition into a residential care facility: older people's experiences. J Adv Nurs. 2010 May;66(5):1159-68. doi: 10.1111/j.1365-2648.2010.05280.x.

    PMID: 20423358BACKGROUND
  • Hermann C. Bonsai as a group art therapy intervention among traumatized youth in KwaZulu-Natal. Psych J. 2021 Apr;10(2):177-186. doi: 10.1002/pchj.440. Epub 2021 Mar 9.

    PMID: 33751848BACKGROUND
  • Koppitz AL, Dreizler J, Altherr J, Bosshard G, Naef R, Imhof L. Relocation experiences with unplanned admission to a nursing home: a qualitative study. Int Psychogeriatr. 2017 Mar;29(3):517-527. doi: 10.1017/S1041610216001964. Epub 2016 Nov 17.

    PMID: 27852339BACKGROUND
  • Lan X, Xiao H, Chen Y. Life review for Chinese older adults in nursing homes: cultural acceptance and its effects. Int Psychogeriatr. 2019 Apr;31(4):527-535. doi: 10.1017/S1041610218001084. Epub 2018 Oct 2.

    PMID: 30277193BACKGROUND
  • Mello S, O'Connor KA. Morbidity and Mortality Following Relocation of Highly Dependent Long-Term Care Residents: A Retrospective Analytical Study. J Gerontol Nurs. 2016 Nov 1;42(11):34-38. doi: 10.3928/00989134-20160908-01. Epub 2016 Oct 5.

    PMID: 27711930BACKGROUND
  • Rebok GW, Ball K, Guey LT, Jones RN, Kim HY, King JW, Marsiske M, Morris JN, Tennstedt SL, Unverzagt FW, Willis SL; ACTIVE Study Group. Ten-year effects of the advanced cognitive training for independent and vital elderly cognitive training trial on cognition and everyday functioning in older adults. J Am Geriatr Soc. 2014 Jan;62(1):16-24. doi: 10.1111/jgs.12607. Epub 2014 Jan 13.

    PMID: 24417410BACKGROUND
  • Sun C, Yu Y, Li X, Cui Y, Ding Y, Zhu S, Li X, Chen S, Zhou R. The factors of adaptation to nursing homes in mainland China: a cross-sectional study. BMC Geriatr. 2020 Nov 30;20(1):517. doi: 10.1186/s12877-020-01916-x.

    PMID: 33256628BACKGROUND
  • Sun C, Zhou R, Cui Y, Ding Y, Li X, Li X, Zhang Y, Chen S, Xing Y. The Adaptation of Older Adults' Transition to Nursing Homes in Mainland China: A Qualitative Study. J Transcult Nurs. 2021 Jul;32(4):318-325. doi: 10.1177/1043659620923387. Epub 2020 May 23.

    PMID: 32449461BACKGROUND
  • Wu CS, Rong JR. Relocation experiences of the elderly to a long-term care facility in Taiwan: a qualitative study. BMC Geriatr. 2020 Aug 6;20(1):280. doi: 10.1186/s12877-020-01679-5.

    PMID: 32762717BACKGROUND

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Liping Pu

    Phd candidate of Faculty of Nursing Prince of Songkla University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 8, 2025

First Posted

February 24, 2025

Study Start

July 9, 2025

Primary Completion

July 19, 2025

Study Completion

August 9, 2025

Last Updated

July 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

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)

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
After finishing the research
Access Criteria
Data are available upon written request, in accordance with the General Data Protection Regulation (GDPR)

Locations