Depression, Unipolar, Pain, Postoperative
Conditions
Keywords
postpartum, depression, pain, cesarean
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.
Detailed description
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.
Interventions
BEHAVIORALMindfulness
Meditation training to help reduce stress and reactivity to pain and other stressors.
Sponsors
University of Illinois at Urbana-Champaign
Southern Illinois University
Arrowhead Regional Medical Center
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Postpartum depression | 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. |
Countries
United States
Contacts
CONTACTSandraluz Lara-Cinisomo, Ph.D.
Outcome results
None listed