Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT03802734
Status:
UNKNOWN
Last Update Posted:
2019-12-09
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Sponsor:
Unity Health Toronto
Organization:
Study Overview
Official Title:
Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Status:
UNKNOWN
Status Verified Date:
2019-12
Last Known Status:
ENROLLING_BY_INVITATION
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PaMPPr
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: