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SleepPaMPPrNCT03802734

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

A study testing Mindful meditation phone app in people with Sleep and Pregnancy, run by Unity Health Toronto at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Sleep, Pregnancy
What is being tested?
Mindful meditation phone app
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteCanada
Study dates
15 Aug 2019to 2 Jan 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • St. Michael's Hospital

    Toronto, Ontario, M5B1W8

Other trials in Canada

About this study

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.

Read the 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.

Conditions
Sleep, Pregnancy
Being tested
Mindful meditation phone app

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindful meditation phone appDevice

    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.

Study groups in NCT03802734
Study groupRoleWhat they receive
Mindful Meditation AppExperimentalGroup 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.
Receives: Device: Mindful meditation phone app
No Meditation AppNo interventionGroup B will be given an actigraph and a general pregnancy and sleep information leaflet only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Sleep

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

    Measured: 20 weeks gestation to 6 weeks post partum

  2. Use of Meditation Phone App - minutes per day

    Measured use of the Headspace app in minutes per day

    Measured: 20 weeks gestation to 6 weeks post partum

  3. Use of Meditation Phone App - sessions completed

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

    Measured: 20 weeks gestation to 6 weeks post partum

  4. Use of Meditation Phone App - type of sessions

    Breakdown of the number of different session-types used

    Measured: 20 weeks gestation to 6 weeks post partum

  5. Use of Meditation Phone App - average session length

    Average session length (in minutes)

    Measured: 20 weeks gestation to 6 weeks post partum

  6. Use of Meditation Phone App - total time spent meditating

    Total number of minutes spent meditating using the meditation phone app

    Measured: 20 weeks gestation to 6 weeks post partum

Secondary outcomes (6)

  1. Pittsburgh Sleep Quality Index (PSQI)

    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.

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

  2. Perceived Stress Scale (PSS)

    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.

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

  3. Edinburgh Postnatal Depression Scale (EPDS)

    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.

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

  4. Beck Anxiety Inventory (BAI)

    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.

    Measured: 20 weeks gestation to 6 weeks post partum

  5. Complications during pregnancy

    Complications during pregnancy will be recorded using information collected directly from the participant and information collected from their medical chart.

    Measured: Beginning of pregnancy to delivery

  6. Complications during delivery

    Complications during delivery will be recorded using information collected from the patient's medical chart.

    Measured: Delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2019
  2. Study start15 Aug 2019
  3. Primary completion2 Jan 2021 (estimated)
  4. Study completion2 Jan 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized control trial
Masking
None (open label)
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03802734
Sponsor's protocol ID
18-048
Acronym
PaMPPr
Status last verified
Dec 2019
First submitted
20 Dec 2018
Last updated
9 Dec 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Mindful meditation phone app in people with Sleep and Pregnancy, run by Unity Health Toronto at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sleep (time frame: 20 weeks gestation to 6 weeks post partum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03802734.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2019.

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