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

December 5, 2019 updated by: Unity Health Toronto
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5B1W8
        • St. Michael's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mindful Meditation App
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
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.
No Intervention: No Meditation App
Group B will be given an actigraph and a general pregnancy and sleep information leaflet only.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sleep
Time Frame: 20 weeks gestation to 6 weeks post partum
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
Time Frame: 20 weeks gestation to 6 weeks post partum
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
Time Frame: 20 weeks gestation to 6 weeks post partum
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
Time Frame: 20 weeks gestation to 6 weeks post partum
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
Time Frame: 20 weeks gestation to 6 weeks post partum
Average session length (in minutes)
20 weeks gestation to 6 weeks post partum
Use of Meditation Phone App - total time spent meditating
Time Frame: 20 weeks gestation to 6 weeks post partum
Total number of minutes spent meditating using the meditation phone app
20 weeks gestation to 6 weeks post partum

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: PSQI will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
Participants will rate the frequency of sleep disturbances on a 4-point Likert scale (0 = "Not during the past month"; 1 = "Less than once a week"; 2 = "Once or twice a week"; 3 = "Three or more times a week". Scores will be tallied. A score of 5 or more indicates poor sleep quality. Scores will be compared across 3 time-points.
PSQI will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
Perceived Stress Scale (PSS)
Time Frame: PSS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
Participants will rate the frequency of certain thoughts and feelings over the past month on a 5-point Likert scale (0 = "Never"; 1 = "Almost never"; 2: "Sometimes"; 3: "Fairly often"; 4: "Very often". Scores will be tallied using the special PSS scoring system. Scores will be compared across 3 time-points.
PSS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: EDPS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
This scale measures post-natal and prenatal depression by asking participants to rate how they have felt emotionally during the last 7 days. Various 4-point Likert scales are used to measure the frequency of occurance (e.g. 0 = No never, 1 = Not very often, 2 = Yes, some of the time, 3 = Yes, most of the time). Scores will be tallied to measure level of depression. Higher scores indicate higher levels of post-natal depression. Scores will be compared across 3 time-points.
EDPS will be completed at 3 time-points: <= 20 weeks gestation, 35-40 weeks gestation, 6 weeks post-partum.
Beck Anxiety Inventory (BAI)
Time Frame: 20 weeks gestation to 6 weeks post partum
Participants will indicate the frequency of anxiety symptoms during the past month on a 4-point Likert scale (0 = No not at all, 1 = Mildly, but it didn't bother me much, 2 = Moderately, it wasn't pleasant at times, 3 = Severely, it bothered me a lot). Scores will be tallied to indicate severity of anxiety. Higher scores indicate higher levels of anxiety. Scores will be compared across 3 time-points.
20 weeks gestation to 6 weeks post partum
Complications during pregnancy
Time Frame: Beginning of pregnancy to delivery
Complications during pregnancy will be recorded using information collected directly from the participant and information collected from their medical chart.
Beginning of pregnancy to delivery
Complications during delivery
Time Frame: Delivery
Complications during delivery will be recorded using information collected from the patient's medical chart.
Delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Unity Health Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 2, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 20, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 9, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 14, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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