Cesarean Section Complications, Chronic Pain
Conditions
Brief summary
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence 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.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Stanford University
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 postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth * has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum * 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 1 week) | — |
| Percentage of participants attending Empowered Relief session | Treatment (up to 2 weeks) | — |
| 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). |
| Participant Treatment Skills Use Scale Score | 4 - 6 weeks Post Treatment | Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in PEG scale score (pain interference) | From enrollment to the end of study completion at 6 weeks | Participants complete thrice weekly PEG questionnaire, to assess pain interference via SMS. (Score range 0 - 20, higher score represents a greater degree of interference) |
| Change from baseline in PROMIS Pain Interference 8a scale score | Baseline, Week 6 | 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). |
| Response rate to individual items of the PEG scale score via SMS | From enrollment to the end of study completion at 6 weeks | Participant percentage responding to items of the thrice weekly PEG questionnaire, a 3-item scale assessing pain interference and intensity via SMS. (Score range 0 - 3; higher scores indicate higher response rate) |
| Change from baseline in PEG scale score (pain intensity) | From enrollment to the end of study completion at 6 weeks | Participants complete thrice weekly PEG questionnaire to assess pain intensity, via SMS. (Score range 0 - 10, higher score represents a greater degree of pain intensity) |
| Change from baseline in PROMIS Pain Intensity 3a scale score | Baseline, Week 6 | 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 6 | 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 PEG scale score (composite) | From enrollment to the end of study completion at 6 weeks | Participants complete thrice weekly Pain, Enjoyment, General Activity Scale (PEG) questionnaire, a 3-item scale assessing pain interference and intensity via SMS. (Score range 0 - 30, higher score represents a greater degree of pain intensity/interference) |
Countries
United States
Outcome results
None listed