Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Clinical Trials Registry - India
Year
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2023
INTERVENTION: 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 participant to listen and perform. during the first visit, the researcher will guide the participant regarding the practice. AIM therapy consists of one minute of opening prayer, four minutes of humming bee breathing, 12 minutes of body scan‐guided relaxation in the left lateral position, 12 minutes of so‐hum meditation and one minute of closing prayer. this therapy will be given for 8 weeks. once a week the researcher will assess the mean arterial pressure of the participant before and after the intervention. Control Intervention1: Hospital standard care protocol with relaxation: the participants will be visited once a week for 8 weeks and mean arterial pressure will be assessed before and after the intervention. the participant will be asked to sit for 30 minutes sitting in a relaxed position with legs elevated in a quiet environment for 30 minutes. CONDITION: Health Condition 1: O140‐ Mild to moderate pre‐eclampsia PRIMARY OUTCOME: 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 OUTCOME: 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 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 ; 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)
Epistemonikos ID: dbca4570c69ab9c435d24aecaf9a270c797aa922
First added on: Feb 20, 2024