Clinical trial NCT03737279: Daily Meditation Program in Women Admitted to the Antepartum Unit
Official title: Daily Meditation Program in Women Admitted to the Antepartum Unit: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy, High Risk
Pregnancy Related
Keywords: Pregnancy
Meditation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2018-11-09
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Maternal state anxiety as assessed by the State Anxiety Scale
timeFrame: 1-3 days
Secondary outcomes:
measure: Maternal state anxiety as assessed by the State Anxiety Scale
timeFrame: 1 to 11 weeks.
measure: Stress as assessed by the Perceived Stress Scale
timeFrame: 3 days to 11 weeks.
measure: Depression as assessed by the Edinburgh Depression Scale
timeFrame: 3 days to 11 weeks.
measure: Patient satisfaction
timeFrame: 3 days to 11 weeks.
measure: Latency period
timeFrame: At delivery.
measure: Number of meditation sessions
timeFrame: 11 weeks
measure: Duration of meditation sessions
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Morgen S Doty, DO
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.