Maternal Mindfulness: Depression and Postpartum Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorUniversity of Illinois at Urbana-Champaign
About this trial
This phase I clinical trial tests the feasibility and safety of a self-guided, mobile mindfulness-based intervention to reduce post-cesarean pain and prevent postpartum depression.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White.
Scheduled to undergo a planned cesarean delivery.
Be of 18-45 years of age
Have a singleton pregnancy
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness
BehavioralMeditation training to help reduce stress and reactivity to pain and other stressors.
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: MindfulnessExperimental treatment 1 intervention
Group B: Treatment as usual with monitoringNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Post-operative pain
Numerical Pain Rating Scale (NPRS); Participant reported pain intensity (0 is equivalent to no pain and 10 indicates the worst possible pain) and pain unpleasantness (0 is equivalent to not at all unpleasant and 10 indicates the most unpleasant feeling possible)
Time frame
1 week postpartum and 8 weeks postpartumSecondary outcomes
1
Postpartum depression
Edinburgh Postnatal Depression Scale (EPDS); participant reported depressive symptoms. Those who score above 13 are likely to be suffering from a depressive illness of varying severity.
Time frame
1 week postpartum and 8 weeks postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Illinois at Urbana-Champaign
Lead sponsor
Southern Illinois University
Collaborator
Arrowhead Regional Medical Center
Collaborator
University of Utah
Collaborator
Source ClinicalTrials.gov