Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
A Single-Session Pain Management Intervention for Severe Pain After Cesarean Delivery: A Pilot Feasibility Study
This pilot feasibility study will evaluate the feasibility and acceptability of delivering Empowered Relief (ER), a single-session pain management intervention, to postpartum patients experiencing severe pain following cesarean delivery during the inpatient period. Participants will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to receive either ER in addition to standard postpartum care or standard postpartum care alone. Participants will be followed for 12 weeks postpartum.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Severe acute pain following cesarean delivery may interfere with postpartum recovery and functioning. This pilot feasibility study will evaluate the feasibility of delivering Empowered Relief (ER) during the inpatient postpartum period to patients experiencing severe pain following cesarean delivery.
Eligible participants experiencing severe pain, defined as at least 2 numeric rating scale (NRS) pain scores >6/10 during the inpatient postpartum period, will be enrolled during their inpatient postpartum hospitalization and randomized 1:1 to an intervention or control group. Participants assigned to the intervention group will receive ER in addition to standard postpartum care. ER is a single 120-minute pain relief skills class that includes pain education, cognitive behavioral skills such as relaxation, deep breathing, and cognitive reframing, and development of a personalized plan. Participants will also receive access to a relaxation resource and weekly supportive text messages. Participants assigned to the control group will receive standard postpartum care alone.
The primary objective is to assess the feasibility of delivering the ER intervention during the inpatient postpartum period. Additional feasibility and acceptability outcomes include recruitment, registration and attendance at the ER session, treatment satisfaction, treatment skills use, adherence to study procedures, and participant retention. Pain-related patient-reported outcomes will also be explored over the 12-week follow-up period. Participants will complete follow-up assessments at 3, 6, and 12 weeks postpartum, with brief PEG pain assessments collected weekly through week 12.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Guillermina Ferrea, MD, MSc
- Telefonnummer: (650) 457-7704
- E-post: gferrea@stanford.edu
Studiesteder
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California
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Palo Alto, California, Forente stater, 94304
- Lucile Packard Children's Hospital Stanford
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Ta kontakt med:
- Guillermina Ferrea, MD, MSc
- Telefonnummer: (650) 457-7704
- E-post: gferrea@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), provided the participant is clinically able to complete the study intervention and procedures.
- Currently hospitalized during the postpartum period following cesarean delivery.
- Severe pain, defined as at least 2 pain scores >6/10 on the numeric rating scale (NRS), following cesarean delivery.
- 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.
- Medical or clinical instability that, in the judgment of the treating or research team, would preclude safe participation in the study procedures and/or intervention.
- Chronic pain prior to pregnancy.
- Cognitive impairment or psychological factors that would preclude comprehension of study material or full participation.
- Unable or unwilling to provide informed consent.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- 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). |
|
Ingen inngripen: Standard Postpartum Care
Participants randomized to the control group will receive standard postpartum care alone. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
Tidsramme: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who complete the 120-minute Empowered Relief (ER) session during the inpatient postpartum period. The proportion will be calculated as the number of participants who complete the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
Tidsramme: At screening
|
The proportion of screened patients who meet all study eligibility criteria. The proportion will be calculated as the number of screened patients who are eligible for the study divided by the total number of patients screened. |
At screening
|
|
Proportion of eligible patients that consent to study from those approached
Tidsramme: Baseline (Day 1)
|
The proportion of eligible patients approached for study participation who provide informed consent. The proportion will be calculated as the number of eligible patients who provide informed consent divided by the total number of eligible patients approached for participation. |
Baseline (Day 1)
|
|
Proportion of recruited patients randomized to the ER intervention arm who register for the ER session
Tidsramme: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who register for the Empowered Relief (ER) session. The proportion will be calculated as the number of participants who register for the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
|
|
Proportion of recruited patients randomized to the ER intervention arm who attend the ER session
Tidsramme: Day 1 ± 5 days, during the inpatient postpartum period
|
The proportion of participants randomized to the ER intervention arm who attend the Empowered Relief (ER) session during the inpatient period. The proportion will be calculated as the number of participants who attend the ER session divided by the total number of participants randomized to the ER intervention arm. |
Day 1 ± 5 days, during the inpatient postpartum period
|
|
Treatment Appraisal score (intervention arm)
Tidsramme: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
|
Treatment satisfaction among participants in the ER intervention arm will be assessed using the 7-item Treatment Appraisal scale. Total scores range from 0 to 42, with higher scores indicating greater satisfaction with the intervention. Additional quantitative and categorical items included in the questionnaire are not included in the total score and will be summarized separately. |
Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
|
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Qualitative feedback regarding the ER intervention (intervention arm)
Tidsramme: Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
|
Qualitative feedback regarding the Empowered Relief (ER) intervention will be collected from participants in the ER intervention arm through optional free-text responses. This outcome does not generate a numerical score or scale value. |
Immediately post-intervention or within a defined short window after ER (Day 1 ± 7)
|
|
Participant Treatment Skills Use Scale score (intervention arm)
Tidsramme: Week 3; week 6; week 12
|
Use of skills taught during the Empowered Relief (ER) intervention will be assessed among participants in the ER intervention arm using the 5-item Participant Treatment Skills Use Scale. Total scores range from 5 to 25, with higher scores indicating greater use of the skills. |
Week 3; week 6; week 12
|
|
Adherence to study procedures: Completion rate of scheduled surveys
Tidsramme: From enrollment through end-of-study (12-week follow-up)
|
The percentage of scheduled study surveys completed by enrolled participants. |
From enrollment through end-of-study (12-week follow-up)
|
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Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments
Tidsramme: Weekly from enrollment through end-of-study (12-week follow-up)
|
The percentage of scheduled Pain, Enjoyment, General Activity (PEG) assessments completed by enrolled participants. |
Weekly from enrollment through end-of-study (12-week follow-up)
|
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Adherence to study procedures: Participant retention through end-of-study follow-up
Tidsramme: From enrollment through end-of-study (12-week follow-up)
|
The proportion of enrolled participants who remain in the study through the end-of-study follow-up assessment. |
From enrollment through end-of-study (12-week follow-up)
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
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
Andre studie-ID-numre
- 88454
- K24DA053564 (U.S. NIH-stipend/kontrakt)
- R90HD118650 (U.S. NIH-stipend/kontrakt)
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