Cesarean Section Complications, Postpartum Care
Conditions
Brief summary
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.
Interventions
BEHAVIORALEmpowered Relief
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.
OTHEREducation
Educational content: Participants view videos online focusing on specific areas of postpartum recovery (Sleep, Mental Health, Physical Therapy, Obstetric care).
Sponsors
Stanford University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Females 18 years of age or older * Any woman scheduled for a cesarean delivery in the Stanford Healthcare system with a viable birth * English fluency * Ability to adhere to and complete study protocols * Access to smart device for zoom / video meetings
Exclusion criteria
* \<18yrs * chronic pain prior to pregnancy * Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants registering for Empowered Relief session | Baseline (up to 2 weeks) | — |
| Percentage of participants attending Empowered Relief session | Treatment (up to 2 weeks) | — |
| Empowered Relief: Participant Satisfaction Scale Score | 1 - 2 weeks Post treatment | Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment). |
| Empowered Relief: Participant Treatment Skills Use Scale Score | Week 3, Week 8, Week 14 | Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment). |
| Percentage of participants watching educational content | Treatment (up to 2 weeks), Week 3 | — |
| Educational content: Participant Satisfaction Scale Score | 1 - 2 weeks Post treatment, Week 3, Week 8, Week 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PROMIS Pain Interference 8a scale score | Baseline, Week 3, Week 8, Week 14 | 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). |
| Change from baseline in PROMIS Pain Intensity 3a scale score | Baseline, Week 3, Week 8, Week 14 | 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) |
| Change from baseline in Pain Catastrophizing Scale Score | Baseline, Week 3, Week 8, Week 14 | 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) |
| Change from baseline in Pain Interference Scale Score via SMS | Baseline through end of study (up to 14 weeks) | Participants complete twice weekly questionnaire to assess pain interference via SMS. (Score range 0 - 10, higher score represents a greater degree of interference) |
| Response rate to Pain Interference scale score via SMS | Baseline through end of study (up to 14 weeks) | This outcome determines the percentage of participants responding to the twice weekly pain interference scale score via SMS text. |
| Change from baseline in PROMIS Sleep Disturbance 8a scale score | Baseline, Week 3, Week 8, Week 14 | 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). |
| Change from baseline in STanford Obstetric Recovery checKlist (STORK) scale score | Baseline, Week 2, Week 3, Week 8, Week 14 | 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORPervez Sultan
Stanford University
Outcome results
None listed