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.
Przegląd badań
Status
Interwencja / Leczenie
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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California
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Palo Alto, California, Stany Zjednoczone, 94304
- Rekrutacyjny
- Stanford Medicine Children's Health - Specialty Services, Welch Road
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Główny śledczy:
- Pervez Sultan, MD
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Kontakt:
- Pervez Sultan, MD
- Numer telefonu: (669) 800 9929
- E-mail: psultan@stanford.edu
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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). |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of enrolled patients that complete the Empowered Relief session
Ramy czasowe: Within 2 weeks of enrollment
|
The proportion of enrolled patients that complete the single 120-minute Empowered Relief session. |
Within 2 weeks of enrollment
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
Ramy czasowe: 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
Ramy czasowe: 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
|
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Proportion of recruited patients who register for the Empowered Relief session
Ramy czasowe: Within 1 week of enrollment
|
The proportion of recruited patients who register for the Empowered Relief session. |
Within 1 week of enrollment
|
|
Proportion of recruited patients who attend the Empowered Relief session
Ramy czasowe: Within 2 weeks of baseline
|
The proportion of recruited patients who attend an Empowered Relief session. |
Within 2 weeks of baseline
|
|
Treatment Appraisal score
Ramy czasowe: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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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
Ramy czasowe: Immediately after the Empowered Relief session, up to 2 weeks post-treatment
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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
|
|
Participant Treatment Skills Use Scale score
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 84718
- K24DA053564 (Grant/umowa NIH USA)
- R90HD118650 (Grant/umowa NIH USA)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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