Daily Meditation Program in Women Admitted to the Antepartum Unit (Meditate)

The University of Texas System (UT)

Status: Completed

Conditions: Pregnancy Related; Pregnancy, High Risk

Treatments: Behavioral: Routine Care; Behavioral: Meditation

Study type: Interventional

Funder types: Other

Identifiers

NCT03737279

HSC-MS-18-0810

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Meditation

Experimental group

Description:

Intervention Group: Routine care plus twice daily mindful meditation

Treatment:

Behavioral: Routine Care

Behavioral: Meditation

Routine care

Active Comparator group

Description:

Control Group: Routine care which includes ACOG educational pamphlets on day 1, 2 and 3 after randomization

Treatment:

Behavioral: Routine Care