Pregnancy, High Risk, Pregnancy Related
Conditions
Keywords
Pregnancy, Meditation
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.
Interventions
BEHAVIORALMeditation
Routine care + twice daily meditation per schedule, to start on the day of randomization
BEHAVIORALRoutine Care
Routine care including ACOG educational pamphlets: * Day 1: Nutrition in Pregnancy * Day 2: Heart Health for Women * Day 3: Exercise after Pregnancy
Sponsors
The University of Texas Health Science Center, Houston
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Number of meditation sessions | 11 weeks | Meditation sessions as reported per patient and documented by phone application. |
| Duration of meditation sessions | 11 weeks | Meditation duration as reported per patient and documented by phone application. |
| Latency period | At delivery. | Latency period is defined as time from randomization until delivery |
Countries
United States
Outcome results
None listed