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Mindfulness Training for Pregnancy-Related Hypertension

N/A

Recruiting

Led By Margaret H Bublitz

Research Sponsored by Lifespan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before and after the intervention, approximately 3 months

Awards & highlights

Study Summary

This trial will test whether a mindfulness intervention can help prevent hypertensive disorders of pregnancy, which are a leading cause of maternal morbidity and mortality. The intervention will be delivered via phone, and participants will be asked to wear a wrist-worn biosensor.

Who is the study for?

This trial is for English-speaking pregnant women under 20 weeks' gestation, with blood pressure below 140/90, and at moderate to high risk for hypertensive disorders. It's not for those with multiple pregnancies, severe depression or psychosis, or who regularly practice mind-body activities like yoga or meditation.Check my eligibility

What is being tested?

The study tests if mindfulness training can prevent hypertension during pregnancy without medication. Participants will either receive an 8-week phone-delivered mindfulness intervention or usual care. The effects on maternal blood pressure and stress-related parameters will be measured using surveys and biosensors.See study design

What are the potential side effects?

Mindfulness training is generally considered safe but may include temporary increases in distress as individuals become more aware of their experiences. Physical side effects are rare but could include mild discomfort from wearing a wrist-worn biosensor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before and after the intervention, approximately 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before and after the intervention, approximately 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and before and after the intervention, approximately 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Perceived stress and mood responses to momentary stress

Secondary outcome measures

Heart rate response to momentary stress

Perceived and received support in response to momentary stress

Trial Design

2Treatment groups

Experimental Treatment

Group I: Treatment as usualExperimental Treatment1 Intervention

Prenatal care

Group II: Mindfulness trainingExperimental Treatment1 Intervention

Phone-delivered mindfulness training

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mindfulness training

2005

Completed Phase 3

~1860

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

LifespanLead Sponsor

40 Previous Clinical Trials

40,938 Total Patients Enrolled

2 Trials studying Hypertension

50 Patients Enrolled for Hypertension

Margaret H BublitzPrincipal InvestigatorThe Miriam Hospital

Media Library

Mindfulness training Clinical Trial Eligibility Overview. Trial Name: NCT04626245 — N/A

Hypertension Research Study Groups: Mindfulness training, Treatment as usual

Hypertension Clinical Trial 2023: Mindfulness training Highlights & Side Effects. Trial Name: NCT04626245 — N/A

Mindfulness training 2023 Treatment Timeline for Medical Study. Trial Name: NCT04626245 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being sought for this study?

"Affirmative, the clinicaltrials.gov entry for this research indicates that it is in its recruitment phase; originally posted on June 13th of 2022 and last updated on June 24th of 2022. The trial necessitates 150 participants being enrolled at a single site."

Answered by AI

Are there still available enrollments in this clinical experiment?

"Affirmative. Clinicaltrials.gov corroborates that this clinical trial, which was first published on June 13th 2022, is currently recruiting volunteers. Approximately 150 individuals need to be enrolled from 1 medical facility."

Answered by AI

Is the age threshold for participation in this clinical study restricted to 35 years and younger?

"The requirements for joining this clinical trial are that individuals must be aged 18 to 60. Separately, there are 4 trials focusing on minors and 22 other studies targeting seniors over the age of 65."

Answered by AI

Who is best suited for inclusion in this clinical research experiment?

"This medical study requires the recruitment of 150 individuals with hypertension during pregnancy, aged between 18 and 60. The necessary conditions include a singleton pregnancy, english fluency, gestation at enrollment below 20 weeks, BP lower than 140/90 mmHg and moderate to high risk for hypertensive disorders in pregnant women."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Mindfulness & Mechanisms Study

Margaret Bublitz 2022. "Mindfulness & Mechanisms Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04626245.

All > Blood Pressure > Pregnancy