Clincosm LogoSign in Get a demo

Meditate: Daily Meditation Program in Women Admitted to the Antepartum Unit

Sponsor
The University of Texas Health Science Center, Houston (Other)
Overall Status
Completed
CT.gov ID
NCT03737279
Collaborator
(none)
56
Enrollment
1
Location
2
Arms
12.9
Actual Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Meditation
  • Behavioral: Routine Care
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial
Actual Study Start Date :
Mar 4, 2019
Actual Primary Completion Date :
Apr 1, 2020
Actual Study Completion Date :
Apr 1, 2020

Arms and Interventions

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"

Outcome Measures

Primary Outcome Measures

  1. Maternal state anxiety as assessed by the State Anxiety Scale [1-3 days]

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

Secondary Outcome Measures

  1. Maternal state anxiety as assessed by the State Anxiety Scale [1 to 11 weeks.]

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

  2. Stress as assessed by the Perceived Stress Scale [3 days to 11 weeks.]

    The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating a higher stress level.

  3. Depression as assessed by the Edinburgh Depression Scale [3 days to 11 weeks.]

    The Edinburgh Depression Scale score ranges from 0 to 30, with higher scores indicating a higher depression level.

  4. Patient satisfaction [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.

  5. Latency period [At delivery.]

    Latency period is defined as time from randomization until delivery

  6. Number of meditation sessions [11 weeks]

    Meditation sessions as reported per patient and documented by phone application.

  7. Duration of meditation sessions [11 weeks]

    Meditation duration as reported per patient and documented by phone application.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 The University of Texas Health Science Center at Houston Houston Texas United States 77030

Sponsors and Collaborators

  • The University of Texas Health Science Center, Houston

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Morgen Doty, Principal Investigator, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT03737279
Other Study ID Numbers:
  • HSC-MS-18-0810
First Posted:
Nov 9, 2018
Last Update Posted:
Jun 16, 2020
Last Verified:
Jun 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Morgen Doty, Principal Investigator, The University of Texas Health Science Center, Houston
Pregnancy
Meditation

Study Results

No Results Posted as of Jun 16, 2020