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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05400382
Other study ID # MaMiDaPP
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date March 31, 2026

Study information

Verified date May 2022
Source University of Illinois at Urbana-Champaign
Contact Sandraluz Lara-Cinisomo, Ph.D.
Phone 217-300-3512
Email laracini@illinois.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.


Description:

This clinical trial will test the effect of a mobile mindfulness-based intervention on reducing post-cesarean delivery pain and preventing postpartum depression.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 75
Est. completion date March 31, 2026
Est. primary completion date March 31, 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - 18-45 years of age, have a singleton pregnancy, score less than 10 on the Edinburgh Postnatal Depression Scale (EPDS; (Cox et al., 1987b), willing to participate in the eight-week intervention or be randomized to the TAUM condition, have no significant psychiatric disorders other than depression or anxiety (e.g., bipolar disorder, substance use disorder, etc.), have no chronic pain condition (e.g., fibromyalgia), and proficient in English or Spanish Exclusion Criteria: - Women who screen 10 or higher on the EPDS

Study Design


Intervention

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

Locations

Country Name City State
n/a

Sponsors (5)

Lead Sponsor Collaborator
University of Illinois at Urbana-Champaign Arrowhead Regional Medical Center, Feinberg School of Medicine, Northwestern University, Southern Illinois University, University of Pittsburgh Medical Center

Outcome

Type Measure Description Time frame Safety issue
Primary Postpartum depression depressive symptoms EPDS 13 or higher 4 weeks - 6 months
Secondary Post-operative pain Post-cesarean delivery pain 4 weeks - 6 months
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