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

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ClinicalTrials.gov Identifier: NCT03737279
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : March 15, 2019
Sponsor:
Information provided by (Responsible Party):
Morgen Doty, The University of Texas Health Science Center, Houston

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
Pregnancy, High Risk Pregnancy Related Behavioral: Meditation Behavioral: Routine Care Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : March 4, 2019
Estimated Primary Completion Date : December 18, 2019
Estimated Study Completion Date : January 2, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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"




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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. 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.

  4. 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.

  5. Latency period [ Time Frame: At delivery. ]
    Latency period is defined as time from randomization until delivery

  6. Number of meditation sessions [ Time Frame: 11 weeks ]
    Meditation sessions as reported per patient and documented by phone application.

  7. Duration of meditation sessions [ Time Frame: 11 weeks ]
    Meditation duration as reported per patient and documented by phone application.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03737279


Contacts
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Contact: Morgen S Doty, DO 7135006410 morgen.s.doty@uth.tmc.edu
Contact: Sunbola Ashimi 7135006410 sunbola.s.ashimi@uth.tmc.edu

Locations
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United States, Texas
The University of Texas Health Science Center at Houston Recruiting
Houston, Texas, United States, 77030
Contact: Morgen S Doty, DO    713-500-6421    morgen.s.doty@uth.tmc.edu   
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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Principal Investigator: Morgen S Doty, DO The University of Texas Health Science Center, Houston

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Responsible Party: Morgen Doty, Principal Investigator, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT03737279     History of Changes
Other Study ID Numbers: HSC-MS-18-0810
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Morgen Doty, The University of Texas Health Science Center, Houston:
Pregnancy
Meditation