The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) and educational content on global postpartum recovery at 12 weeks post cesarean delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.
Educational content: Participants view videos online focusing on specific areas of postpartum recovery (Sleep, Mental Health, Physical Therapy, Obstetric care).
Stanford University
Palo Alto, California, United States
Percentage of participants registering for Empowered Relief session
Time frame: Baseline (up to 2 weeks)
Percentage of participants attending Empowered Relief session
Time frame: Treatment (up to 2 weeks)
Empowered Relief: Participant Satisfaction Scale Score
Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).
Time frame: 1 - 2 weeks Post treatment
Empowered Relief: Participant Treatment Skills Use Scale Score
Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
Time frame: Week 3, Week 8, Week 14
Percentage of participants watching educational content
Time frame: Treatment (up to 2 weeks), Week 3
Educational content: Participant Satisfaction Scale Score
Participant satisfaction will be measured using a 7 item questionnaire with three scored items: overall usefulness (0-6), the usefulness rating of each module (0-6), and frequency of use (0-3). The composite score ranges from 0-15, with higher scores indicating greater satisfaction and use. Additional checklist and free-text items capture engagement but are not included in the score.
Time frame: 1 - 2 weeks Post treatment, Week 3, Week 8, Week 14
Change from baseline in PROMIS Pain Interference 8a scale score
Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of pain interference).
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Time frame: Baseline, Week 3, Week 8, Week 14
Change from baseline in PROMIS Pain Intensity 3a scale score
Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days. (Score range 3 - 15, higher score represents a greater degree of pain intensity)
Time frame: Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Catastrophizing Scale Score
Participants complete Pain Catastrophizing questionnaire, a 13-item scale assessing an individual's pain experience (Score range 0 - 52, higher score represents a greater degree of pain catastrophizing)
Time frame: Baseline, Week 3, Week 8, Week 14
Change from baseline in Pain Interference Scale Score via SMS
Participants complete twice weekly questionnaire to assess pain interference via SMS. (Score range 0 - 10, higher score represents a greater degree of interference)
Time frame: Baseline through end of study (up to 14 weeks)
Response rate to Pain Interference scale score via SMS
This outcome determines the percentage of participants responding to the twice weekly pain interference scale score via SMS text.
Time frame: Baseline through end of study (up to 14 weeks)
Change from baseline in PROMIS Sleep Disturbance 8a scale score
Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Sleep Disturbance 8a questionnaire, an 8-item scale assessing self-reported perceptions of sleep quality, sleep depth, restoration, perceived difficulties and concerns with getting to sleep/staying asleep, as well as perceptions of the adequacy and satisfaction with sleep over the past 7 days. (Score range 8 - 40, higher scores represent a greater degree of sleep disturbance).
Time frame: Baseline, Week 3, Week 8, Week 14
Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score
Participants complete the STORK questionnaire, a 47-item scale assessing postpartum recovery over the past 7 days. (Score range 0 - 188, higher score represents a greater degree of recovery)
Time frame: Baseline, Week 2, Week 3, Week 8, Week 14