Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001194752
Ethics application status
Approved
Date submitted
12/08/2022
Date registered
6/09/2022
Date last updated
6/09/2022
Date data sharing statement initially provided
6/09/2022
Date results provided
6/09/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
An evaluation of a magic-based intervention on mental health and quality of life among the community-dwelling older adults
Scientific title
An evaluation of a magic-based intervention on self-esteem, depressive symptoms and quality of life among the community-dwelling older adults
Secondary ID [1] 307766 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Community-dwelling older adults without major illness 327340 0
Condition category
Condition code
Alternative and Complementary Medicine 324470 324470 0 0
Other alternative and complementary medicine
Mental Health 324618 324618 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 324619 324619 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants of both groups received health education on mental health at the beginning of the intervention (week 0). The content was the way to recognize when one's mental health needs extra help and strategies to improve mental health. It was delivered by a structured power-point presentation to all participants at once by a member of the study team in a single 60-minute session.
The magic intervention program designed for the older adults started a week later and was held for 90 minutes (min) twice a week for 6 weeks and taught by an experienced teacher who was both a family physician and a professional magician, and qualified as a tutor of the Programs to Prevent or Delay Disability by the Ministry of Health and Welfare. The method of teaching was a pre-planned group lesson with 8-12 participants and 1 teacher. Well-designed and easy-to-master props and interactive parlor magic were chosen for the course design. Each magic lesson, except for the first and last ones, was composed of (1) a review of the magic tricks taught in the previous class (10 min), (2) a demonstration of magic tricks by the teacher as part of and designed for the lesson (5 min), (3) a discussion by the participants of the possible explanations behind the magic tricks (10 min), (4) a revelation by the teacher of the secrets behind the gimmicks and magic tricks (5 min), (5) the participants learning and making their props (25 min), (6) the participants practicing the performing skills (20 min), and finally, (7) the participants performing their magic shows on the stage in a group of four to five for 15 minutes and receiving applause from the other participants. There was a total of 12 lessons, and each used a different theme, such was a coin disappeared when covered with a transparent cup, a rolled newspaper grown into a large flowering tree, and a paperclip turned into a banknote, etc. Attendance records was used to monitor adherence to the intervention.
Intervention code [1] 324228 0
Treatment: Other
Comparator / control treatment
All participants of both groups received health education on mental health at the beginning of the intervention (week 0). The participants in the control group continued their original life routine and daily activities and were given the option to enroll in the magic intervention program in week 8 (after the main study was over).
Control group
Active

Outcomes
Primary outcome [1] 332283 0
Change in the Rosenberg Self-Esteem Scale (RSE) scores
Timepoint [1] 332283 0
Baseline and 7 weeks after intervention commencement.
Primary outcome [2] 332284 0
Change in the 15-item Geriatric Depression Scale (GDS-15) scores
Timepoint [2] 332284 0
Baseline and 7 weeks after intervention commencement.
Primary outcome [3] 332285 0
Change in the brief version of the World Health Organization Quality of Life questionnaire Taiwan version (WHOQOL-BREF-TW) scores
Timepoint [3] 332285 0
Baseline and 7 weeks after intervention commencement.
Secondary outcome [1] 413477 0
nil
Timepoint [1] 413477 0
nil

Eligibility
Key inclusion criteria
The participants were recruited from a community activity center and out-patient family medicine clinics in a community hospital. Volunteers were screened for the following inclusion criteria: (1) 60 - 90 years old, (2) not currently taking antidepressant medication, (3) not currently having problems with alcohol and/or substance dependence, (4) not having primary axis I psychiatric diagnosis, (5) not currently on psychotherapy, (6) having a score of greater than or equal to 24 in the Mini-Mental State Examination (MMSE), and (7) having a score of less than or equal to 10 in the 15-item Geriatric Depression Scale (GDS-15).
Minimum age
60 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria included (1) having medical conditions associated with symptoms of depression (e.g., thyroid disease, hyperparathyroidism, Cushing’s syndrome, adrenal insufficiency, acute hepatitis, acute kidney injury, anemia, systemic infectious disease, and/or malignancy) and (2) having an acute unstable neurological disease (e.g., acute stroke within the past six months and/or dementia with behavioral and psychological symptoms).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified randomization based on enrollment sources and gender.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We considered a medium effect size with Cohen's f to be 0.2544 for the present study. G*Power software45 was used for a priori sample size estimation. A sample size of 34 (a = 0.05, 1-ß = 0.80) was sufficient to detect a medium effect.
The primary outcome was the participants’ post-intervention self-esteem levels, depressive status and QoL. Repeated measures analysis of variance was conducted to compare the pre- and post-intervention scores of RSE, GDS-15 and WHOQOL-BREF-TW in the 2 (group: intervention vs. control) × 2 (time: pre-intervention vs. post-intervention) setting. The secondary outcomes were the correlations between self-esteem and depressive status, as well as between depressive status and QoL calculated using Pearson’s correlation coefficients.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/09/2021
Date of last participant enrolment
Anticipated
Actual
8/04/2022
Date of last data collection
Anticipated
Actual
27/05/2022
Sample size
Target
34
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 24951 0
Taiwan, Province Of China
State/province [1] 24951 0
Tainan

Funding & Sponsors
Funding source category [1] 312036 0
Hospital
Name [1] 312036 0
National Cheng Kung University Hospital
Country [1] 312036 0
Taiwan, Province Of China
Funding source category [2] 312039 0
Government body
Name [2] 312039 0
National Health Research Institute
Country [2] 312039 0
Taiwan, Province Of China
Primary sponsor type
Hospital
Name
National Cheng Kung University Hospital
Address
No. 138, Sheng-Li Road, Tainan City 704
Country
Taiwan, Province Of China
Secondary sponsor category [1] 313544 0
None
Name [1] 313544 0
Address [1] 313544 0
Country [1] 313544 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311452 0
The Institutional Review Board of the National Cheng Kung University Hospital
Ethics committee address [1] 311452 0
Ethics committee country [1] 311452 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 311452 0
Approval date [1] 311452 0
03/08/2021
Ethics approval number [1] 311452 0
A-ER-110-159

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 121142 0
Dr Wei-Li Wang
Address 121142 0
No. 138, Sheng-Li Road, National Cheng Kung University Hospital, Tainan City 70403
Country 121142 0
Taiwan, Province Of China
Phone 121142 0
+886912705765
Fax 121142 0
Email 121142 0
[email protected]
Contact person for public queries
Name 121143 0
Wei-Li Wang
Address 121143 0
No. 138, Sheng-Li Road, National Cheng Kung University Hospital, Tainan City 70403
Country 121143 0
Taiwan, Province Of China
Phone 121143 0
+886062353535
Fax 121143 0
Email 121143 0
[email protected]
Contact person for scientific queries
Name 121144 0
Wei-Li Wang
Address 121144 0
No. 138, Sheng-Li Road, National Cheng Kung University Hospital, Tainan City 70403
Country 121144 0
Taiwan, Province Of China
Phone 121144 0
+886062353535
Fax 121144 0
Email 121144 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal.
Available for what types of analyses?
To achieve the aims in the approved proposal or for IPD meta-analyses.
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.