Cesarean Section Complications, Chronic Pain, Postpartum
Conditions
Keywords
Empowered Relief, Postpartum Pain, Cesarean Section, Caesarean Section, Cesarean Delivery, Pain Interference, Pain Management, Chronic Pain, Chronic Postsurgical Pain, Postpartum
Brief summary
This pilot study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain relief skills class, to postpartum women with ongoing pain and/or pain interference following cesarean delivery. Participants will receive ER in addition to standard postpartum care and will be followed through 12 weeks postpartum.
Interventions
BEHAVIORALEmpowered Relief
A single 120-minute pain relief skills class delivered by trained, certified instructors via Zoom or in person. The session includes pain education, cognitive behavioral skills including relaxation, deep breathing, and reframing, and completion of a personalized plan. Following the session, participants receive access to the Calm Tool smartphone relaxation app (or a binaural relaxation audio file if the app cannot be downloaded).
Sponsors
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Complete informed consent. 2. Age 18 years or above. 3. Postpartum woman who delivered by cesarean within the Stanford Healthcare system. 4. Viable birth (singleton or multiple gestation). 5. All maternal demographics and complications are eligible: parity, medical conditions (e.g., pre-eclampsia, gestational diabetes), and post-surgical complications (e.g., hysterectomy, ICU admission, extended hospital stay). 6. All neonatal complications are eligible (e.g., NICU admission, extended hospital stay) 7. Attend the 6-week postpartum clinic visit. 8. Any pain intensity (numeric rating scale \[NRS\] \>0/10) and/or pain interference (PROMIS pain interference 8a score \>8) at 6 weeks postpartum. 9. English fluency, with ability to read and write. 10. Ability to adhere to and complete study procedures. 11. Access to a smart device if attending ER session via Zoom.
Exclusion criteria
1. Age under 18 years. 2. Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation. 3. Unable or unwilling to provide informed consent. 4. Chronic pain prior to pregnancy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of enrolled patients that complete the Empowered Relief session | Within 2 weeks of enrollment | The proportion of enrolled patients that complete the single 120-minute Empowered Relief session. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of screened patients who are eligible for the study | During screening, at approximately 6 weeks postpartum | The proportion of screened patients that meet the study eligibility criteria. |
| Proportion of eligible patients that consent to study from those approached | During screening and enrollment, at approximately 6 weeks postpartum | The proportion of eligible patients who provide informed consent and enroll in the study. |
| Proportion of recruited patients who register for the Empowered Relief session | Within 1 week of enrollment | The proportion of recruited patients who register for the Empowered Relief session. |
| Proportion of recruited patients who attend the Empowered Relief session | Within 2 weeks of baseline | The proportion of recruited patients who attend an Empowered Relief session. |
| Treatment Appraisal score | Immediately after the Empowered Relief session, up to 2 weeks post-treatment | Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention |
| Qualitative feedback regarding the Empowered Relief intervention | Immediately after the Empowered Relief session, up to 2 weeks post-treatment | Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire. |
| Participant Treatment Skills Use Scale score | Weekly from completion of the Empowered Relief session through 12 weeks postpartum | Use of skills learned during the Empowered Relief intervention assessed using the 5-item Participant Treatment Skills Use Scale. Total scores range from 0 to 25, with higher scores indicating greater use of treatment skills. |
| Adherence to Study Procedures: completion rate of scheduled surveys | From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum | The percentage of scheduled study surveys completed by enrolled participants. |
| Adherence to study procedures: completion rate of scheduled PEG assessments | From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum | The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants. |
| Adherence to study procedures: proportion of participants retained through end-of-study follow-up | From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum | The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment. |
Countries
United States
Outcome results
None listed