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a study to verify the impact of mindfulness-based relaxation exercises on the average blood pressure, stress, and anxiety of pregnant women with high blood pressure, as well as on the growth of unborn baby for eight weeks, and how these affect the women and baby till delivery.

Efficacy of Audio Instructed Mindfulness therapy (AIM) on Mean Arterial Pressure, stress, anxiety, materno-fetal physiological parameters among pregnant women with pregnancy induced hypertension of Udupi district, Karnataka - A randomized control trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050800
Enrollment
96
Registered
2023-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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

Conditions

Health Condition 1: O140- Mild to moderate pre-eclampsia

Interventions

Intervention1: Audio Instructed Mindfulness therapy: This is a 30-minute audio which is mindfulness-based. the audio consists of pre-recorded clear and complete instructions that will help the partici

Sponsors

Mrs Prathibha Lydia Braggs
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Antenatal mothers: > aged between 20 to 40 years > with singleton pregnancies > between 20 to 26 weeks of gestation > with spontaneous conception > diagnosed with mild pregnancy-induced hypertension (BP 140-150 mmm Hg/90-100 mm Hg)

Exclusion criteria

Exclusion criteria: Antenatal mothers: > diagnosed to have diabetes mellitus, thyroid disorders, bleeding disorders, renal and heart diseases, known uterine disorders, musculoskeletal disorders > known mental illness > diagnosed with hearing difficulties or ear infections.

Design outcomes

Primary

MeasureTime frame
Mean Arterial PressureTimepoint: Total of 16 measurement points every week first day at the beginning of the intervention and end of the intervention I week - point measurement 1,2 II week - 3,4 III week - 5,6 IV week - 7,8 V week - 9,10 VI week - 11,12 VII wk - 13,14 VIII wk - 15,16—

Secondary

MeasureTime frame
Stress, anxiety, sleep quality, C-Reactive protein, ESR, Platelet count, Protein-creatinine ratio, maternal umbilical artery and uterine artery pulsatility index. Estimated fetal intrauterine weight and fetal growth percentile.Timepoint: 2-time points measurement for Stress, Anxiety, Sleep quality, C Reactive protein, ESR, Plateletcount, Protein Creatinine ratio, Maternal Umbilical artery and Uterine artery PI, Fetal intrauterine weight and growth percentile I measurement - at the time of recruitment II measurement - at the end of 8 weeks of intervention ;Maternal Outcomes - Gestational weeks at delivery, mode of delivery, delivery complications developed if anyTimepoint: 1 - at the delivery;Neonatal outcomes - Birth weight, APGAR score, Need for NICU/ Ventilator support, Neonatal convulsions/sepsisTimepoint: 1 - at the time of delivery—

Countries

India

Contacts

Public ContactDr Judith A Noronha

Manipal College of Nursing

judith.n@manipal.edu9448506594

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026