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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03802734
Recruitment Status : Enrolling by invitation
First Posted : January 14, 2019
Last Update Posted : December 9, 2019
Sponsor:
Information provided by (Responsible Party):
St. Michael's Hospital, Toronto

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.

Condition or disease Intervention/treatment Phase
Sleep Pregnancy Device: Mindful meditation phone app Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized control trial
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Perinatal Effects of Mindfulness Phone App Use in Pregnancy (PaMPPr Study)
Actual Study Start Date : August 15, 2019
Estimated Primary Completion Date : January 2, 2021
Estimated Study Completion Date : January 2, 2021

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. Use of Meditation Phone App - average session length [ Time Frame: 20 weeks gestation to 6 weeks post partum ]
    Average session length (in minutes)

  6. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Complications during delivery [ Time Frame: Delivery ]
    Complications during delivery will be recorded using information collected from the patient's medical chart.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant women
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03802734


Locations
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Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Investigators
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Principal Investigator: Howard Berger, MD St. Michael's Hospital, Toronto
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Responsible Party: St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier: NCT03802734    
Other Study ID Numbers: 18-048
First Posted: January 14, 2019    Key Record Dates
Last Update Posted: December 9, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No