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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03737279
Other study ID # HSC-MS-18-0810
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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