Clinical trial NCT03802734: Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Official title: Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep
Pregnancy
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 128
Sex: FEMALE
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized control trial
Primary purpose: OTHER

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 traditional 8-10 weeks mindfulness classroom program with some home practice. This time-intensive classroom training may be expensive and not convenient for many busy pregnant women. This study will investigate the use of a smartphone app-based intervention to determine if it has the potential to make mindfulness training more accessible, acceptable, and convenient to a larger number of pregnant women. The use of an app as opposed to traditional structured classes may increase a woman's ability and willingness to practice mindfulness because the app can be used almost anywhere and at any time. This pilot study aims to explore the feasibility and acceptability of a smartphone mindfulness meditation application for pregnant women. As well, this study will compare the pregnancy outcomes of women who use the app to those women who do not use the app.

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 maternal health such as sleep, stress, depression, anxiety and other perinatal outcomes (premature delivery, diabetes during pregnancy (gestational diabetes), high blood pressure in pregnancy (hypertensive disorders of pregnancy), inadequate growth of the baby inside the womb (fetal growth restriction), bleeding in later pregnancy, mode of delivery, pain relief during delivery, length of stay for mother and baby in the hospital, admission of baby in ICU, pain relief medication requirement after delivery, and breastfeeding).

Participants will be randomly assigned to either group A (the experimental group) or group B (the control group). All participants will be given a an actigraph to measure sleep.

Participants in Group A will be given a free subscription to a mindfulness meditation app for six months. They will also be given a general pregnancy sleep leaflet. Participants assigned to Group B will be given the general pregnancy sleep leaflet only.

There will be 3 visits associated with this study. At each of the 3 visits, participants will be given four questionnaires to complete - the Pittsburgh Sleep Quality Index, Perceived Stress Questionnaire, Beck's Anxiety Inventory, and the Edinburgh Postnatal Depression Scale. Participants in Group A will also be asked to complete a fifth survey at their post-partum visit. This survey will collect information on how easy it was to use the mindfulness meditation app.

Information on delivery outcomes will also be collected. This information will include things such as any complications that occur during delivery, baby's birth weight and Apgar score, any complications with baby's health, method of delivery, and pain medications used during delivery.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Sleep
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Use of Meditation Phone App - minutes per day
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Use of Meditation Phone App - sessions completed
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Use of Meditation Phone App - type of sessions
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Use of Meditation Phone App - average session length
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Use of Meditation Phone App - total time spent meditating
timeFrame: 20 weeks gestation to 6 weeks post partum
Secondary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: PSQI will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
measure: Perceived Stress Scale (PSS)
timeFrame: PSS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
measure: Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: EDPS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
measure: Beck Anxiety Inventory (BAI)
timeFrame: 20 weeks gestation to 6 weeks post partum
measure: Complications during pregnancy
timeFrame: Beginning of pregnancy to delivery
measure: Complications during delivery
timeFrame: Delivery
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
Study officials:
affiliation: Unity Health Toronto
name: Howard Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: