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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
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).
Stanford Medicine Children's Health - Specialty Services, Welch Road
Palo Alto, California, United States
Proportion of enrolled patients that complete the Empowered Relief session
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.
Time frame: Within 2 weeks of enrollment
Proportion of screened patients who are eligible for the study
The proportion of screened patients that meet the study eligibility criteria.
Time frame: During screening, at approximately 6 weeks postpartum
Proportion of eligible patients that consent to study from those approached
The proportion of eligible patients who provide informed consent and enroll in the study.
Time frame: During screening and enrollment, at approximately 6 weeks postpartum
Proportion of recruited patients who register for the Empowered Relief session
The proportion of recruited patients who register for the Empowered Relief session.
Time frame: Within 1 week of enrollment
Proportion of recruited patients who attend the Empowered Relief session
The proportion of recruited patients who attend an Empowered Relief session.
Time frame: Within 2 weeks of baseline
Treatment Appraisal score
Treatment satisfaction assessed using the 7-item treatment appraisal questionnaire. Range 0-42, higher = greater satisfaction with the intervention
Time frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
Qualitative feedback regarding the Empowered Relief intervention
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Participant feedback regarding the Empowered Relief intervention, provided through optional free-text responses included in the Treatment Appraisal Questionnaire.
Time frame: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
Participant Treatment Skills Use Scale score
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.
Time frame: Weekly from completion of the Empowered Relief session through 12 weeks postpartum
Adherence to Study Procedures: completion rate of scheduled surveys
The percentage of scheduled study surveys completed by enrolled participants.
Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Adherence to study procedures: completion rate of scheduled PEG assessments
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants.
Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
Adherence to study procedures: proportion of participants retained through end-of-study follow-up
The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment.
Time frame: From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum