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NCT Number: NCT05400382

Maternal Mindfulness: Depression and Postpartum Pain

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

Location status: Recruiting

Location contact

Sandraluz Lara-Cinisomo, Ph.D

CONTACT

[email protected]

217-300-3512

About this study

Postpartum pain affects approximately 92% of women and is a risk factor for postpartum depression (PPD). Cesarean delivery is associated with elevated risk for both postpartum pain and PPD, and women who experience persistent postpartum pain are at increased risk of developing depressive symptoms. PPD may contribute to withdrawal, emotional detachment, and hostility, which can negatively affect mother-infant interactions, including breastfeeding. These risks underscore the urgent need for an effective non-pharmacologic intervention to reduce post-cesarean delivery pain and prevent PPD. The objective of this study is to optimize a mobile, self-guided 8-week Mindfulness-Based Stress Reduction (MBSR) intervention for non-depressed women at risk for PPD who have a planned cesarean delivery. The investigators will conduct a single-group open trial of women (N = 20), including Latinas (English- and Spanish-speaking), Asian, African American, and non-Hispanic White women. The study is testing two primary hypotheses: (1) the 8-week mobile MBI will demonstrate high feasibility and acceptability among a diverse sample of women, shown by meeting target recruitment, enrollment, and retention benchmarks and (2) participants will demonstrate reductions in reported pain scores and depressive symptoms from pre- to post-intervention. In addition, the study will evaluate recruitment, enrollment, dosage, safety, and retention metrics and survey participants about intervention features, facilitators, barriers, satisfaction, and recommendations.

Participants will be recruited through community partners, including the Champaign-Urbana Public Health District and the University YMCA, using flyers, partner-supported distribution of study information, and email announcements. Interested individuals will complete an online eligibility screener accessed through a QR code or URL on recruitment materials. Eligible participants will include women with an Edinburgh Postnatal Depression Scale score of 5-13 who have a planned singleton cesarean delivery, are within 18-45 years of age, and have no chronic pain condition. Individuals who meet initial eligibility criteria will be contacted by phone to confirm participant authenticity, then sent a REDCap link to complete electronic consent and a background questionnaire. After enrollment, participants will meet briefly with a trained research assistant to review access to the intervention platform and address any questions or concerns. Recruitment and enrollment will occur during the third trimester of pregnancy, and the intervention will begin during the first week following cesarean delivery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • 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
  • Score between 5 and 13 on the Edinburgh Postnatal Depression Scale (EPDS)
  • A history of depression
  • Have no chronic pain condition (e.g., fibromyalgia)
  • Own a computer, smartphone, or tablet
  • Have a reliable internet access to complete the online surveys.
  • Be proficient in English or Spanish.

Treatment and study plan

Mindfulness

Behavioral

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

Other names: Mindfulness meditation

Primary outcomes

  1. Post-operative pain

    Time frame: 1 week postpartum and 8 weeks postpartum

    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)

Secondary outcomes

  1. Postpartum depression

    Time frame: 1 week postpartum and 8 weeks postpartum

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandraluz Lara-Cinisomo, Ph.D.

CONTACT

[email protected]

217-300-3512

Sponsors and collaborators

Lead sponsor

University of Illinois at Urbana-Champaign

Other

Collaborators

  • Arrowhead Regional Medical Center
  • Southern Illinois University
  • University of Utah

Registry information

Official study title

Maternal Mindfulness to Prevent Depression and Reduce Postpartum Pain (MaMiDaPP) Intervention

Acronym: MaMiDaPP

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Jun 1, 2022
Registry last updated
Aug 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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