| 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 (in lay language) | Mind on arthritis study | |
| Acronym, if any | None | |
| Brief title, if any | None | |
| Any
other number(s) assigned to the trial and issuing authoruty, if any (eg. sponsor, other trial registry) |
None | |
| Disease or Health Condition(s) studied | Rheumatoid arthritis | |
| 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? | |
| Study design | 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 | |
| Intervention(s) planned | 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 | |
| Target number / sample size | 175 | |
| Primary outcome(s) | 1.Reductions in pain in visual analogue scale 2.Reduction in the number of joints affected 3.Improvements in the primary mental health status | |
| Primary outcome(s) - time of assessment(s) | ||
| Secondary outcome(s) | 1.Duration of symptom free state 2.Duration of sustained improvement of symptoms | |
| Secondary outcome(s) - time of assessment(s) | ||
| Countries of recruitment | Sri Lanka | |
| Anticipated start date | 15/06/2008 | |
| Anticipated end date | 15/12/2008 | |
| Recruitment status | Completed | |
| State of ethics review approval | Approved by the Ethical Review Committee of Faculty of Medicine, University of Colombo | |
| Funding source(s) | Ministry of Health | |
| Applicant's Email | wasantg@hotmail.com | |
| Approval Status | Approved | |
| 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 |
|
| Primary Study Sponsor/ Organization | Dr. L.S Wijeratne
Dept. of Rheumatology, NHSL, Colombo 0777300414 0112698443 lalithsw@sltnet.lk |
|
| Contact Person for Public Queries | Dr.M.W Gunathunga Senior Lecturer in Communiy Medicine 121/24, Pio Mawatha, Kandana 0714272871 0112677765 wasantg@hotmail.com |
|
| Secondary Study Sponsor(s), (if any) | None |
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