. 2023 Oct 24;2023(10):CD014722. doi: 10.1002/14651858.CD014722.pub2

015.

Study name	Effectiveness of a mindfulness‐based intervention on physiological and psychological parameters in pregnant women in Anuradhapura district, Sri Lanka
Methods	Study design: cluster‐RCT Country: Sri Lanka
Participants	Pregnant women Inclusion criteria:  a. pregnant women of all ages; b. registered in ‘pregnant mothers register’ of public health midwives and visiting field antenatal clinics in Anuradhapura district; c. plan to reside in Anuradhapura district throughout their pregnancy; d. in their second trimester (POA/gestational age 13–28 weeks). Exclusion criteria: a. pregnant women who are planning to leave the study area prior to delivery; b. unable to read or understand spoken Sinhala language; c. history of or current psychotic disease; d. severe physical illnesses limiting mobility. Stated purpose: to test the effectiveness of a mindfulness‐based intervention on physiological and psychological parameters in pregnant women in Anuradhapura district, Sri Lanka
Interventions	Intervention: Mindfulness intervention Weekly mindfulness intervention which will be carried out for a duration of 6 weeks. Each session will be 1.5 hours to 2 hours long and will be carried out in a Sinhala medium. Each session will comprise a talk on mindfulness principles, a session on simple mindful movements (Tai Chi introductory exercises) carried out in the seated position and simple meditation sessions, such as awareness of the breath, loving kindness meditation and awareness of the present moment. Control: Usual care (routine antenatal care: at the field level is the care provided to pregnant mothers by the public health staff mainly including the area medical officer of health (MOH) and the area public health midwife (PHM) according to the maternal care package guidelines given by the Family Health Bureau. The services are provided via antenatal clinics, domiciliary visits by the public health staff).
Outcomes	Participants'outcomes of interest for this review Mental health symptoms/depression – Depression Anxiety Stress Scale (DASS‐21) Mental health symptoms/anxiety – Depression Anxiety Stress Scale, DASS‐21) Mental health symptoms/distress/PTSD – Depression Anxiety Stress Scale (DASS‐21) Economic outcomes Nil Time points: baseline, post‐intervention (after the 6th week of intervention)
Starting date	1 June 2021 (first enrolment)
Contact information	Dr. Sujanthi Priyanka Wickramage, sujanthi.wickramage@gmail.com
Notes	Source of funding: World Bank AHEAD project Prospective trial registration number: SLCTR/2020/015