Daily Meditation Program in Women Admitted to the Antepartum Unit
- Conditions
- Pregnancy RelatedPregnancy, High Risk
- Interventions
- Behavioral: MeditationBehavioral: Routine Care
- Registration Number
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 56
- ≥ 18 years of age
- ≥ 23.0 weeks gestation
- Planned inpatient care for > 3 days from randomization
- Women cared for by UT physicians
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meditation Meditation Intervention Group: Routine care plus twice daily mindful meditation Meditation Routine Care Intervention Group: Routine care plus twice daily mindful meditation Routine care Routine Care Control Group: Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization
- Primary Outcome Measures
Name Time Method 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
Name Time Method Latency period At delivery. Latency period is defined as time from randomization until delivery
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.
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.
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.
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.
Duration of meditation sessions 11 weeks Meditation duration as reported per patient and documented by phone application.
Number of meditation sessions 11 weeks Meditation sessions as reported per patient and documented by phone application.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States