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Effectiveness of a mindfulness-based intervention on physiological and psychological parameters in pregnant women in Anuradhapura district, Sri Lanka – A randomized controlled trial

Effectiveness of a mindfulness-based intervention on physiological and psychological parameters in pregnant women in Anuradhapura district, Sri Lanka

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2020/015
Enrollment
Unknown
Registered
2020-06-09
Start date
2021-06-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Changes in physiological and psychological parameters in pregnancy

Interventions

The study will be conducted in selected MOH areas in Anuradhapura District. In the selected MOH areas, clusters will be randomly allocated to intervention (5 clusters) and control (5 clusters) groups

Sponsors

Prof Tusitha Abeythunga
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Pregnant women, • of all ages • registered in ‘pregnant mothers register’ of public health midwives and visiting field antenatal clinics in Anuradhapura district. • who plan to reside in Anuradhapura district throughout their pregnancy • pregnant women in their second trimester (POA/gestational age 13 – 28 weeks)

Exclusion criteria

Exclusion criteria: Pregnant women, * who are planning to leave the study area prior to delivery * who are unable to read or understand spoken Sinhala language * with a history of or current psychotic disease * with severe physical illnesses limiting mobility

Design outcomes

Primary

MeasureTime frame
Mindfulness will be assessed using three questionnaires (translated to Sinhala and validated); 1. Mindful Assessment Awareness Scale – State (MAAS – State) 2. Mindful Assessment Awareness Scale – Trait (MAAS – Trait) 3. Depression, Anxiety, Stress Scale – Short version (DASS-21) [One week prior to introducing the intervention and just after the 6th week of conducting the intervention]

Secondary

MeasureTime frame
Outcomes will be measured in both intervention and control groups Respiratory rate using palpatory method with physician’s hand on participant’s epigastrium [One week prior to introducing the intervention and just after the 6th week of conducting the intervention] Outcomes will be measured in both intervention and control groups Pulse rate using palpatory method, radial pulse [One week prior to introducing the intervention and just after the 6th week of conducting the intervention] Outcomes will be measured in both intervention and control groups Arterial blood pressure using Aneroid sphygmomanometer, stethoscope, auscultatory method [One week prior to introducing the intervention and just after the 6th week of conducting the intervention] Outcomes will be measured in both intervention and control groups Serum cortisol level using Chemiluminescence immunoassay. Machine used: Liaison Diasorian [One week prior to introducing the intervention and just after the 6th week of conducting the intervention] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [ ] [] [] [] [ ] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] [] []

Countries

Sri Lanka

Contacts

Public ContactDr. Sujanthi Priyanka Wickramage

Head/Senior Lecturer in Physiology

sujanthi.wickramage@gmail.com0252234612

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026