Home » Trials » SLCTR/2008/019
Effect of a mind development program on the clinical profile and primary mental health status of patients with rheumatoid arthritis (RA)
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SLCTR Registration Number
SLCTR/2008/019
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
Effect of a mind development program on the clinical profile and primary mental health status of patients with rheumatoid arthritis (RA)
Public Title of Trial
Mind on arthritis study
Disease or Health Condition(s) Studied
Rheumatoid arthritis
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
EC/08/061 (Approved by the Ethics Review Committee of the Faculty of Medicine, University of Colombo)
What is the research question being addressed?
Can eightfold path meditation improve the clinical outcomes and primary mental health status patients with chronic rheumatoid arthritis?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Masking not used
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Supportive care
Study Phase
Not Available
Intervention(s) planned
A quasi experimental design will be used. Two groups will be selected. One group will receive a mind development exercise in addition to the standard treatment. The other group (comparison group) will receive standard treatment. Pre-intervention assessment of primary mental health status, pain and disability will be done. Assessment of socio-demographic status will be done in both groups to assess the comparability. Post intervention assessments will be done periodically. A facilitator will conduct the meditation sessions periodically and the patients will be trained to practice it at home in addition to the sessions during clinics
Inclusion criteria
Patients above twelve years attending a rheumatology clinic in NHSL
Exclusion criteria
Those patients who have major psychiatric illnesses in the exacerbation phase
Primary outcome(s)
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1.
Reductions in pain in visual analogue scale 2. |
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2.
Reduction in the number of joints affected 3. |
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3.
Improvements in the primary mental health status |
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Secondary outcome(s)
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1.
Duration of symptom free state |
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2.
Duration of sustained improvement of symptoms |
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Target number/sample size
175
Countries of recruitment
Sri Lanka
Anticipated start date
2008-06-15
Anticipated end date
2008-12-15
Date of first enrollment
Date of study completion
Recruitment status
Complete: follow up continuing
Funding source
Ministry of Health, Sri Lanka
Regulatory approvals
Status
Approved
Date of Approval
2008-05-15
Approval number
EC/08/061
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Colombo |
| Institutional Address: | No. 25, Kynsey Road, Colombo 00800 Sri Lanka |
| Telephone: | +94-11-2695300 (Extension: 240) |
| Email: | ethicscommitteemfc@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr.M.W Gunathunga
Senior Lecturer in Communiy Medicine
121/24, Pio Mawatha, Kandana
0714272871
0112677765
wasantg@hotmail.com
Contact Person for Public Queries
Dr.M.W Gunathunga
Senior Lecturer in Communiy Medicine
121/24, Pio Mawatha, Kandana
0714272871
0112677765
wasantg@hotmail.com
Primary study sponsor/organization
Dr. L.S Wijeratne
Dept. of Rheumatology, NHSL, Colombo
0777300414
0112698443
lalithsw@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Not Available
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
