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Behavioural Intervention

Mindful Meditation App for Sleep (PaMPPr Trial)

N/A
Waitlist Available
Led By Howard Berger, MD
Research Sponsored by Unity Health Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Are able to understand and sign this consent form
Have a singleton pregnancy (not having twins)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks gestation to 6 weeks post partum
Awards & highlights

PaMPPr 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. 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.

Eligible Conditions
  • Sleep
  • Pregnancy

PaMPPr Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PaMPPr Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 weeks gestation to 6 weeks post partum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 20 weeks gestation to 6 weeks post partum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Sleep
Use of Meditation Phone App - average session length
Use of Meditation Phone App - minutes per day
+3 more
Secondary outcome measures
Beck Anxiety Inventory (BAI)
Complications during delivery
Complications during pregnancy
+3 more

PaMPPr Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Mindful Meditation AppExperimental Treatment1 Intervention
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.
Group II: No Meditation AppActive Control1 Intervention
Group B will be given an actigraph and a general pregnancy and sleep information leaflet only.

Find a Location

Who is running the clinical trial?

Unity Health TorontoLead Sponsor
533 Previous Clinical Trials
446,335 Total Patients Enrolled
2 Trials studying Sleep
19,130 Patients Enrolled for Sleep
Howard Berger, MDPrincipal InvestigatorUnity Health Toronto
8 Previous Clinical Trials
458 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~23 spots leftby Mar 2025