Home » Trials » SLCTR/2017/020
Clinical trial on effectiveness of mindfulness meditation on improving cognitive functions in people over 60 years of age
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SLCTR Registration Number
SLCTR/2017/020
Date of Registration
The date of last modification
Mar 03, 2019
Scientific Title of Trial
Clinical trial on effectiveness of mindfulness meditation on improving cognitive functions in people over 60 years of age
Public Title of Trial
The Effects of Mindfulness Meditation on Cognitive Functions among People over 60 years of age
Disease or Health Condition(s) Studied
Mild cognitive impairment in the elderly
Scientific Acronym
None
Public Acronym
None
Brief title
Effects of Mindfulness on Cognitive functions
Universal Trial Number
U1111-1197-8890
Any other number(s) assigned to the trial and issuing authority
P/127/05/2017 (ERC: Kelaniya)
What is the research question being addressed?
What is the effect of mindfulness meditation on cognitive functions in people over 60 years?
Type of study
Interventional
Study design
Allocation
Single arm study
Masking
Masking not used
Control
Uncontrolled
Assignment
Single
Purpose
Supportive care
Study Phase
Not Applicable
Intervention(s) planned
The study will be carried out at the Professorial Medicine Unit, North Colombo Teaching Hospital (NCTH) Ragama.
Random cluster sampling method will be used to select study participants. All consecutive consenting participants meeting inclusion/exclusion criteria will be recruited until target sample size is achieved.
Mindfulness meditation will be modeled on basic Buddhist Anapanasathi (meditation on breathing) methods. Meditation training will be conducted by a facilitator with experience in teaching meditation. The intervention will be provided in small groups (3-5 participants). Trainer guided meditation programme will be provided only on the first day and the programme will take about 30 minutes.
As a manipulation check, each subject will be asked after meditation session, ‘‘Did you feel that you were truly meditating?”
Participants will be provided with an audio aid (CD) to practice the meditation programme by their own at home. They will be advised to follow the meditation programme which will run for 20 minutes (at a specified time) every day for 6 weeks.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
Improvement of Mini Mental Score Examination (MMSE) |
[ At baseline, 6 weeks after the commencement of the intervention and 2 months after the conclusion of the intervention ] |
|
2.
Improvement of Montreal Cognitive Assessment (MoCA) |
[ At baseline, 6 weeks after the commencement of the intervention and 2 months after the conclusion of the intervention ] |
Secondary outcome(s)
|
1.
Improvement of Extended cognitive assessments: |
[ At baseline, 6 weeks after the commencement of the intervention and 2 months after the conclusion of the intervention ] |
Target number/sample size
60
Countries of recruitment
Sri Lanka
Anticipated start date
2017-07-15
Anticipated end date
2017-10-16
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
None (Investigator funded)
Regulatory approvals
Not applicable
Status
Approved
Date of Approval
2018-05-09
Approval number
P/127/05/2017
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Asiri Rodrigo
Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama,
Sri Lanka
Tel: 0112961000
Mob: 0777865791
asirir2000@yahoo.com
Contact Person for Public Queries
Dr. Asiri Rodrigo
Lecturer and Consultant Psychiatrist
Department of Psychiatry, Faculty of Medicine, University of Kelaniya, Ragama,
Sri Lanka
Tel: 0112961000
Mob: 0777865791
asirir2000@yahoo.com
Primary study sponsor/organization
Department of Psychiatry, Faculty of Medicine, University of Kelaniya
Ragama, Sri Lanka
Tel: +94-11-2958039
Fax: +94-11-2958337
http://medicine.kln.ac.lk/depts/phychiatry/
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
