NCT03737279

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 9, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

March 4, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2020

Completed
Last Updated

June 16, 2020

Status Verified

June 1, 2020

Enrollment Period

1.1 years

First QC Date

October 23, 2018

Last Update Submit

June 11, 2020

Conditions

Pregnancy, High RiskPregnancy Related

Keywords

PregnancyMeditation

Outcome Measures

Primary Outcomes (1)

  • Maternal state anxiety as assessed by the State Anxiety Scale

    The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level.

    1-3 days

Secondary Outcomes (7)

  • Maternal state anxiety as assessed by the State Anxiety Scale

    1 to 11 weeks.

  • Stress as assessed by the Perceived Stress Scale

    3 days to 11 weeks.

  • Depression as assessed by the Edinburgh Depression Scale

    3 days to 11 weeks.

  • Patient satisfaction

    3 days to 11 weeks.

  • Latency period

    At delivery.

  • +2 more secondary outcomes

Study Arms (2)

Meditation

EXPERIMENTAL

Intervention Group: Routine care plus twice daily mindful meditation

Behavioral: MeditationBehavioral: Routine Care

Routine care

ACTIVE COMPARATOR

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

Behavioral: Routine Care

Interventions

MeditationBEHAVIORAL

Routine care + twice daily meditation per schedule, to start on the day of randomization

Meditation
Routine CareBEHAVIORAL

Routine care including ACOG educational pamphlets: * Day 1: "Nutrition in Pregnancy" * Day 2: "Heart Health for Women" * Day 3: "Exercise after Pregnancy"

MeditationRoutine care

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • Doty MS, Chen HY, Ajishegiri O, Sibai BM, Blackwell SC, Chauhan SP. Daily meditation program for anxiety in individuals admitted to the antepartum unit: a multicenter randomized controlled trial (MEDITATE). Am J Obstet Gynecol MFM. 2022 May;4(3):100562. doi: 10.1016/j.ajogmf.2022.100562. Epub 2022 Jan 12.

    PMID: 35031521DERIVED

MeSH Terms

Interventions

Meditation

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Morgen S Doty, DO

    The University of Texas Health Science Center, Houston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 23, 2018

First Posted

November 9, 2018

Study Start

March 4, 2019

Primary Completion

April 1, 2020

Study Completion

April 1, 2020

Last Updated

June 16, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)