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Completed

NCT Number: NCT03737279

Daily Meditation Program in Women Admitted to the Antepartum Unit

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.

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Key information

Conditions

Pregnancy, High Risk Pregnancy Related

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meditation

Behavioral

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

Routine Care

Behavioral

Routine care including ACOG educational pamphlets:

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Acronym: Meditate

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 9, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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