Reducing Chronic Pain Following Cesarean Delivery
A Pilot Feasibility Study of an Intervention to Reduce Chronic Pain Following Cesarean Delivery
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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
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California
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Palo Alto, California, Forente stater, 94304
- Rekruttering
- Stanford Medicine Children's Health - Specialty Services, Welch Road
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Hovedetterforsker:
- Pervez Sultan, MD
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Ta kontakt med:
- Pervez Sultan, MD
- Telefonnummer: (669) 800 9929
- E-post: psultan@stanford.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Complete informed consent.
- Age 18 years or above.
- Postpartum woman who delivered by cesarean within the Stanford Healthcare system.
- Viable birth (singleton or multiple gestation).
- 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).
- All neonatal complications are eligible (e.g., NICU admission, extended hospital stay)
- Attend the 6-week postpartum clinic visit.
- Any pain intensity (numeric rating scale [NRS] >0/10) and/or pain interference (PROMIS pain interference 8a score >8) at 6 weeks postpartum.
- English fluency, with ability to read and write.
- Ability to adhere to and complete study procedures.
- Access to a smart device if attending ER session via Zoom.
Exclusion Criteria:
- Age under 18 years.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
- Chronic pain prior to pregnancy.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Empowered Relief
Participants will receive a single 120-minute Empowered Relief session in addition to standard postpartum care. The session includes pain education and cognitive-behavioral pain management skills, including relaxation, deep breathing, reframing, and development of a personalized plan. Participants will also receive access to a smartphone relaxation resource (Calm Tool app, or a relaxation audio file if the app cannot be downloaded). |
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). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of enrolled patients that complete the Empowered Relief session
Tidsramme: Within 2 weeks of enrollment
|
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session. |
Within 2 weeks of enrollment
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
Tidsramme: During screening, at approximately 6 weeks postpartum
|
The proportion of screened patients that meet the study eligibility criteria. |
During screening, at approximately 6 weeks postpartum
|
|
Proportion of eligible patients that consent to study from those approached
Tidsramme: During screening and enrollment, at approximately 6 weeks postpartum
|
The proportion of eligible patients who provide informed consent and enroll in the study. |
During screening and enrollment, at approximately 6 weeks postpartum
|
|
Proportion of recruited patients who register for the Empowered Relief session
Tidsramme: Within 1 week of enrollment
|
The proportion of recruited patients who register for the Empowered Relief session. |
Within 1 week of enrollment
|
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Proportion of recruited patients who attend the Empowered Relief session
Tidsramme: Within 2 weeks of baseline
|
The proportion of recruited patients who attend an Empowered Relief session. |
Within 2 weeks of baseline
|
|
Treatment Appraisal score
Tidsramme: 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 |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
|
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Qualitative feedback regarding the Empowered Relief intervention
Tidsramme: 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. |
Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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Participant Treatment Skills Use Scale score
Tidsramme: 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. |
Weekly from completion of the Empowered Relief session through 12 weeks postpartum
|
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Adherence to Study Procedures: completion rate of scheduled surveys
Tidsramme: 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. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
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Adherence to study procedures: completion rate of scheduled PEG assessments
Tidsramme: 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. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
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Adherence to study procedures: proportion of participants retained through end-of-study follow-up
Tidsramme: 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. |
From baseline at approximately 6 weeks postpartum through end-of-study at approximately 12 weeks postpartum
|
Samarbeidspartnere og etterforskere
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
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