Efficacy of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women - A Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- Enrollment
- 166
- Locations
- 1
- Primary Endpoint
- To assess the effectiveness of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women.
Study Overview
Brief Summary
The study will be started after obtaining ethical clearance from Institutional Ethics Committee. Informed & written consent will be taken prior the recruitment. All study participants in the study will undergo detailed history (present, past, gynaecological, medical, and family history) followed by general physical examination. The participants will be selected on the basis of inclusion criteria and will be randomly assigned to the yoga or control groups in a 1:1 ratio; the randomization will be done by using a computer program. 4 scales will be used for assessment & follow up i.e. Pittsburgh Sleep Quality Index (PSQI) (19), The Menopause-specific Quality of Life (MENQOL) (20), Menopause rating scale (MRS) (21) and Insomnia Severity Index (ISI).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 40.00 Year(s) to 55.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Perimenopausal women between ages 40 to 55years with recent onset of sleep disturbances.
- •Having sleep disturbances 3 nights/wk at least for 3 months(12) Women not having any psychiatric illness Accessibility to smartphone Willing to participate Practising sleep hygiene.
Exclusion Criteria
- •Having psychiatric disorders,anxiety or heart disease.
- •Co-existing Orthopaedic problems and chronic illnesses.
- •Current participation in structured exercise or yoga programs Undergoing hormone replacement therapy H/O cancer Premature ovarian failure.
Outcomes
Primary Outcomes
To assess the effectiveness of Yoga along with Standard Treatment versus Standard Treatment alone for Sleep Disturbances among Perimenopausal Women.
Time Frame: TFrom Baseline to end of intervention at week 4 week 8 week 12.
Secondary Outcomes
- 1. To assess the effect of Yoga on other somatic symptoms among Perimenopausal Women(2. To assess the effect of yoga on overall QOL among Perimenopausal Women.)
Investigators
Dr Neel Kamal
Government Institute of Medical Sciences(GIMS)