Maternal Mindfulness: Depression and Postpartum Pain

NCT05400382 | Recruiting DMC

• 1 other identifier: MaMiDaPP
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Depression, Unipolar; Pain, Postoperative

Keywords

postpartum; depression; pain; cesarean

Outcome Measures

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)

  1 week postpartum and 8 weeks postpartum

Secondary Outcomes (1)

• Postpartum depression

  1 week postpartum and 8 weeks postpartum

Study Arms (2)

Mindfulness

EXPERIMENTAL

Receiving mobile, self-guided mindfulness intervention

Behavioral: Mindfulness

Treatment as usual with monitoring

NO INTERVENTION

Receiving treatment as usual with monitoring by study PI and investigators.

Interventions

Mindfulness BEHAVIORAL

Meditation training to help reduce stress and reactivity to pain and other stressors.

Also known as: Mindfulness meditation

Mindfulness

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

1. Women must self-identify as Latina/Latinx/Hispanic, Asian, African American, or non-Hispanic White. 2. Scheduled to undergo a planned cesarean delivery. 3. Be of 18-45 years of age 4. Have a singleton pregnancy 5. Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS) 6. A history of depression 7. Have no chronic pain condition (e.g., fibromyalgia) 8. Own a computer, smartphone, or tablet 9. Have a reliable internet access to complete the online surveys. 10. Be proficient in English or Spanish.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Southern Illinois University: collaborator
• Arrowhead Regional Medical Center: collaborator
• University of Utah: collaborator

Study Sites (1)

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

RECRUITING

MeSH Terms

Conditions

Depressive Disorder; Pain, Postoperative; Depression; Pain

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Sandraluz Lara-Cinisomo, Ph.D.

CONTACT

217-300-3512; laracini@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The 8-week intervention will begin in the first week post-cesarean delivery. Before the intervention begins at week 1, participants are requested to complete Numerical Pain Rating Scale (NPRS), Edinburgh Postnatal Depression Scale (EPDS), Data Collection Worksheet (DCW), Five Facet Mindfulness Questionnaire (FFMQ), Mindful Attention Awareness Scale (MAAS), Postpartum Depression Predictor (PDPI- Postpartum), Self-Acceptance Scale for Postpartum Women (SAS-PPW), Flourishing scale (FS), and Listening to Mothers California survey, Postpartum Bonding Questionnaire (PBQ) which may take approximately 20 minutes to complete (see Section 23, item 23.3 for all measures). Each intervention week, participants will engage in: A 5-10-minute self-guided mindfulness-based stress reduction (MBSR) practice through audio recordings through Canvas Free for teacher based on the submitted scripts. Based on the submitted scripts, a 5-minute self-guided audio home practice session will be provided.

Study Record Dates

• First Submitted: May 27, 2022
• First Posted: June 1, 2022
• Study Start: December 1, 2025
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: August 6, 2026

Record last verified: 2026-08

Locations

US (1)