Daily Meditation Program in Women Admitted to the Antepartum Unit

Study Overview
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Brief Summary
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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.

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

Conditions
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Pregnancy, High Risk, Pregnancy Related

Intervention / Treatment
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* Behavioral: Meditation
* Behavioral: Routine Care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Meditation<br>Intervention Group: Routine care plus twice daily mindful meditation | Behavioral: Meditation<br>* Routine care + twice daily meditation per schedule, to start on the day of randomization<br>Behavioral: Routine Care<br>* Routine care including ACOG educational pamphlets: Day 1: Nutrition in Pregnancy Day 2: Heart Health for Women Day 3: Exercise after Pregnancy<br>|
| Active Comparator: Routine care<br>Control Group: Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization | Behavioral: Routine Care<br>* Routine care including ACOG educational pamphlets: Day 1: Nutrition in Pregnancy Day 2: Heart Health for Women Day 3: Exercise after Pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal state anxiety as assessed by the State Anxiety Scale | The State Anxiety Scale Ranges from 20 to 80, with higher scores indicating a higher anxiety level. | 1-3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal state anxiety as assessed by the State Anxiety Scale | The State Anxiety Scale score ranges from 20 to 80, with higher scores indicating a higher anxiety level. | 1 to 11 weeks. | 
| Stress as assessed by the Perceived Stress Scale | The Perceived Stress Scale score ranges from 0 to 40, with higher scores indicating a higher stress level. | 3 days to 11 weeks. | 
| Depression as assessed by the Edinburgh Depression Scale | The Edinburgh Depression Scale score ranges from 0 to 30, with higher scores indicating a higher depression level. | 3 days to 11 weeks. | 
| Patient satisfaction | 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. | 3 days to 11 weeks. | 
| Latency period | Latency period is defined as time from randomization until delivery | At delivery. | 
| Number of meditation sessions | Meditation sessions as reported per patient and documented by phone application. | 11 weeks | 
| Duration of meditation sessions | Meditation duration as reported per patient and documented by phone application. | 11 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pregnancy, Meditation