Recruiting

Mindfulness Intervention

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT05400382

Conditions

Depression, Unipolar

Pain, Postoperative

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

Interventions

Mindfulness

Study Details

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

Study ID

NCT05400382

Start date

Dec 1, 2025

Status verified date

Aug, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 45

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

75 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Mindfulness

Receiving mobile, self-guided mindfulness intervention

no intervention: Treatment as usual with monitoring

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

Interventions

Mindfulness

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

Primary outcome measure

  • Post-operative pain [ Time Frame: 1 week postpartum and 8 weeks postpartum ]

Central Contacts and Locations

Central contacts

Sandraluz Lara-Cinisomo, Ph.D.

217-300-3512laracini@illinois.edu

Locations

University of Illinois Urbana-Champaign

Recruiting

Champaign, Illinois, United States, 61820

Contacts

Sandraluz Lara-Cinisomo, Ph.D

217-300-3512laracini@illinois.edu

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Aug 6, 2026

Last verified

Aug, 2026

Keywords

  • postpartum
  • depression
  • pain
  • cesarean

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2026-08-06.