Daily Meditation Program in Women Admitted to the Antepartum Unit (Meditate)

June 11, 2020 updated by: Morgen Doty, The University of Texas Health Science Center, Houston

Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial

The purpose of this study is to assess whether a daily mindful meditation program for women admitted to the antepartum floor will decrease maternal state anxiety compared to routine care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • The University of Texas health Science Center at Houston

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • ≥ 18 years of age
  • ≥ 23.0 weeks gestation
  • Planned inpatient care for > 3 days from randomization
  • Women cared for by UT physicians

Exclusion Criteria:

  • Known major lethal fetal anomalies (eg. trisomy 13, trisomy 18, anencephaly, Potter's Syndrome)
  • Non-English speaking women
  • Planned delivery ≤ 3 days from randomization
  • Previous fetal surgery in the current pregnancy (twin twin transfusion syndrome laser ablation, spina bifida repair, etc)
  • Women who have practiced a form of meditation in the current pregnancy (including yoga) in the last 4 weeks
  • Women who are currently using patient-controlled analgesia (PCA) (eg. sickle cell crisis)
  • Admission diagnosis of ecclampsia or HELLP (hemolysis, elevated liver enzymes, low platelets) syndrome
  • Diagnosed personality disorder including borderline personality disorder, histrionic personality disorder, schizoid personality disorder, schizotypal personality disorder, schizophrenia
  • Diagnosed anxiety, depression, bipolar or other psychiatric illness on medications for these disorders
  • Non-reassuring fetal heart tracing on admission
  • Intrauterine fetal demise at randomization
  • Inability to gain access to phone application

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Meditation

Intervention Group:

Routine care plus twice daily mindful meditation
Behavioral: Meditation
Routine care + twice daily meditation per schedule, to start on the day of randomization
Behavioral: Routine Care

Routine care including ACOG educational pamphlets:

  • Day 1: "Nutrition in Pregnancy"
  • Day 2: "Heart Health for Women"
  • Day 3: "Exercise after Pregnancy"
Active Comparator: Routine care

Control Group:

Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization
Behavioral: Routine Care

Routine care including ACOG educational pamphlets:

  • Day 1: "Nutrition in Pregnancy"
  • Day 2: "Heart Health for Women"
  • Day 3: "Exercise after Pregnancy"

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal state anxiety as assessed by the State Anxiety Scale
Time Frame: 1-3 days
The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level.
1-3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal state anxiety as assessed by the State Anxiety Scale
Time Frame: 1 to 11 weeks.
The State Anxiety Scale score ranges from 20 to 80, with higher scores indicating a higher anxiety level.
1 to 11 weeks.
Stress as assessed by the Perceived Stress Scale
Time Frame: 3 days to 11 weeks.
The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating a higher stress level.
3 days to 11 weeks.
Depression as assessed by the Edinburgh Depression Scale
Time Frame: 3 days to 11 weeks.
The Edinburgh Depression Scale score ranges from 0 to 30, with higher scores indicating a higher depression level.
3 days to 11 weeks.
Patient satisfaction
Time Frame: 3 days to 11 weeks.
The Patient satisfaction questionnaire will be scored by a 5-point Likert Scale. Two questions will be asked relating to overall experience with the research trial and overall experience in the hospital. Each of the two questions will be rated with a 5-point Likert, with a total score ranging from 2 to 10 and with higher scores indicating a [better/worse] outcome.
3 days to 11 weeks.
Latency period
Time Frame: At delivery.
Latency period is defined as time from randomization until delivery
At delivery.
Number of meditation sessions
Time Frame: 11 weeks
Meditation sessions as reported per patient and documented by phone application.
11 weeks
Duration of meditation sessions
Time Frame: 11 weeks
Meditation duration as reported per patient and documented by phone application.
11 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Investigators

  • Principal Investigator: Morgen S Doty, DO, The University of Texas Health Science Center, Houston

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 4, 2019

Primary Completion (Actual)

April 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

October 23, 2018

First Submitted That Met QC Criteria

November 8, 2018

First Posted (Actual)

November 9, 2018

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 11, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HSC-MS-18-0810

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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