Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)

NCT03802734 | Unknown

• 1 other identifier: 18-048
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pregnancy

Outcome Measures

Primary Outcomes (6)

• Sleep

  Sleep/wake cycles as measured by an accelerometer that measures tri-axial movement (i.e., actigraphy) for qualitative assessment of sleep.

  20 weeks gestation to 6 weeks post partum

• Use of Meditation Phone App - minutes per day

  Measured use of the Headspace app in minutes per day

  20 weeks gestation to 6 weeks post partum

• Use of Meditation Phone App - sessions completed

  Measured use of the Headspace app in total number of sessions completed

  20 weeks gestation to 6 weeks post partum

• Use of Meditation Phone App - type of sessions

  Breakdown of the number of different session-types used

  20 weeks gestation to 6 weeks post partum

• Use of Meditation Phone App - average session length

  Average session length (in minutes)

  20 weeks gestation to 6 weeks post partum

• Use of Meditation Phone App - total time spent meditating

  Total number of minutes spent meditating using the meditation phone app

  20 weeks gestation to 6 weeks post partum

Secondary Outcomes (6)

• Pittsburgh Sleep Quality Index (PSQI)

  PSQI will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.

• Perceived Stress Scale (PSS)

  PSS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.

• Edinburgh Postnatal Depression Scale (EPDS)

  EDPS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.

• Beck Anxiety Inventory (BAI)

  20 weeks gestation to 6 weeks post partum

• Complications during pregnancy

  Beginning of pregnancy to delivery

Study Arms (2)

Mindful Meditation App

EXPERIMENTAL

Group A will be given a free subscription to a mindful meditation phone app for six months. They will also be given an actigraph and a general pregnancy and sleep information leaflet.

Device: Mindful meditation phone app

No Meditation App

NO INTERVENTION

Group B will be given an actigraph and a general pregnancy and sleep information leaflet only.

Interventions

Mindful meditation phone app DEVICE

Participants in the intervention group will be given a free 6-month subscription to a mindful meditation phone app (Headspace). They will also be given an actigraph and a general pregnancy and sleep information leaflet.

Mindful Meditation App

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead

Study Sites (1)

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Study Officials

• Howard Berger, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized control trial

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: January 14, 2019
• Study Start: August 15, 2019
• Primary Completion: January 2, 2021
• Study Completion: January 2, 2021
• Last Updated: December 9, 2019

Record last verified: 2019-12

Locations

CA (1)