Daily Meditation Program in Women Admitted to the Antepartum Unit

Pregnancy Related Clinical Trial

— Meditate  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03737279
• Other study ID #: HSC-MS-18-0810
• Status: Completed
• Phase: N/A
• Start date: March 4, 2019
• Est. completion date: April 1, 2020

Study information

• Verified date: June 2020
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pregnancy Related
• Pregnancy, High Risk

Intervention

Behavioral:
• Meditation
Routine care + twice daily meditation per schedule, to start on the day of randomization
• Routine Care
Routine care including ACOG educational pamphlets: Day 1: "Nutrition in Pregnancy" Day 2: "Heart Health for Women" Day 3: "Exercise after Pregnancy"

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	Latency period	Latency period is defined as time from randomization until delivery	At delivery.
Secondary	Number of meditation sessions	Meditation sessions as reported per patient and documented by phone application.	11 weeks
Secondary	Duration of meditation sessions	Meditation duration as reported per patient and documented by phone application.	11 weeks