Slctr

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

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SLCTR Registration Number

SLCTR/2020/015

Date of Registration

09 Jun 2020

The date of last modification

Mar 17, 2025

Application Summary

Scientific Title of Trial

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

Public Title of Trial

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

Disease or Health Condition(s) Studied

Changes in physiological and psychological parameters in pregnancy

Scientific Acronym

RaPCo-MM

Public Acronym

None

Brief title

Effectiveness of a mindfulness-based intervention in pregnant women

Universal Trial Number

U1111-1245-9167

Any other number(s) assigned to the trial and issuing authority

ERC/2019/31

Trial Details

What is the research question being addressed?

Could an intervention on mindfulness compared to standard antenatal care alone improve physiological and psychological parameters in pregnant women in Anuradhapura district, Sri Lanka?

Type of study

Interventional

Study design

Allocation

Randomized controlled trial

Masking

Masking not used

Control

Standard therapy/practice

Assignment

Parallel

Purpose

Supportive care

Study Phase

Not Applicable

Intervention(s) planned

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 by drawing lots. Therefore, all selected pregnant women in their second trimester registered in a particular antenatal clinic will either receive the mindfulness intervention and routine antenatal care, or only routine antenatal care. Mindfulness based intervention [MBI] will be conducted separately for each cluster at the antenatal clinics on 5 different days.

The intervention will include, a 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 Sinhala medium. The program will be implemented on the participants by the PI and two other investigators, who have had an appreciable mindfulness practice and training. Each session will comprise of 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. All other training investigators will be trained by the PI prior to the intervention.

The control group will receive routine antenatal care.

Routine antenatal care: Routine antenatal care at the field level is the care provided to the 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 midwife [PHM] and shared care with the curative sector as and when necessary.

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

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

Primary outcome(s)

Mindfulness will be assessed using three questionnaires (translated to Sinhala and validated); 1. Mindful Assessment Awareness Scale – State (MAAS – State)

Mindful Assessment Awareness Scale – Trait (MAAS – Trait)
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 outcome(s)

1. 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 ]
2. 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 ]
3. 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 ]
4. 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 ]
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Target number/sample size

56 (28 per arm)

Countries of recruitment

Sri Lanka

Anticipated start date

2021-06-01

Anticipated end date

2021-12-31

Date of first enrollment

Date of study completion

Recruitment status

Pending

Funding source

World Bank AHEAD project

Regulatory approvals

Not applicable

State of Ethics Review Approval

Status

Approved

Date of Approval

2020-01-01

Approval number

ERC/2019/31

Details of Ethics Review Committee

Name:	Ethics Review Committee of the Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka.
Institutional Address:	Ethics Review Committee, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura 50008.
Telephone:	+94(0)25 2053633
Email:	ethicsreviewcommittee@gmail.com

Contact & Sponsor Information

Contact person for Scientific Queries/Principal Investigator

Dr. Sujanthi Priyanka Wickramage
Head/Senior Lecturer in Physiology
Department of Physiology, Faculty of Medicine and Allied Sciences, Rajarata University of Sri Lanka, Saliyapura 50008
0252234612
0776240369

sujanthi.wickramage@gmail.com

Contact Person for Public Queries

Primary study sponsor/organization

Prof Tusitha Abeythunga
Lead Academic Expert Research and Innovation
Prof Tushitha Abeythunga, Lead Academic Expert Research and Innovation, Accelerating Higher Education Expansion and Development (AHEAD) Operation

rdic.ahead@gmail.com

Secondary study sponsor (If any)

Trial Completion details

Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes

IPD sharing plan description

Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices) will be shared. Statistical analysis will be included. Data will be shared following the publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared to achieve the aims in an approved proposal. Data will be available for 5 years from the time of publication.

Study protocol available

Protocol version and date

Not Available

Protocol URL

Not Available

Results summary available

Date of posting results

Date of study completion

Final sample size

Date of first publication

Link to results

Brief summary of results