Status:
UNKNOWN
Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Lead Sponsor:
Unity Health Toronto
Conditions:
Sleep
Pregnancy
Eligibility:
FEMALE
16+ years
Phase:
NA
Brief Summary
There is evidence to show that mindful meditation has a positive impact on health. To date, all the studies done to investigate the effect of mindfulness on pregnancy outcomes have been done through a...
Detailed Description
This is a randomised controlled trial to study the effect of the use of a mindfulness meditation app on pregnancy outcomes. This study will measure how often the app is used, as well as indicators of ...
Eligibility Criteria
Inclusion
- Are able to understand and sign this consent form
- Have a singleton pregnancy (not having twins)
- Are planning to give birth at St. Michael's Hospital
- Have access to personal email, a smartphone, and have a data plan
- Are able to understand and write English
- Are 20-30 weeks into your pregnancy
Exclusion
- Are formally practicing a body-mind activity (except yoga) or currently using a mindfulness/meditation app
- Have a known psychiatric diagnosis or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.)
- Have a mood disorder and/or suicide risk
- Have any medical, infectious, or degenerative disease that may affect mood, behavior, and stress levels
- Have a known fetal anomaly
- Have an uncontrolled medical condition that may interfere with sleep or requires immediate treatment
- Have a comorbid sleep disorder, including obstructive sleep apnea, restless legs syndrome, or circadian rhythm sleep disorders
- Are using hypnotic or sedating medications, antidepressant or antipsychotic medications, or currently under psychopharmacological, behavioral, or psychoanalytic treatment
- Are a night shift worker
Key Trial Info
Start Date :
August 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 2 2021
Estimated Enrollment :
128 Patients enrolled
Trial Details
Trial ID
NCT03802734
Start Date
August 15 2019
End Date
January 2 2021
Last Update
December 9 2019
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8