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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Guillermina Ferrea, MD, MSc
- Numero di telefono: (650) 457-7704
- Email: gferrea@stanford.edu
Luoghi di studio
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California
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Palo Alto, California, Stati Uniti, 94304
- Lucile Packard Children's Hospital Stanford
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Contatto:
- Guillermina Ferrea, MD, MSc
- Numero di telefono: (650) 457-7704
- Email: gferrea@stanford.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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). |
|
Nessun intervento: Standard Postpartum Care
Participants randomized to the control group will receive standard postpartum care alone. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Proportion of screened patients who are eligible for the study
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
|
|
Qualitative feedback regarding the ER intervention (intervention arm)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
|
|
Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments
Lasso di tempo: 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)
|
|
Adherence to study procedures: Participant retention through end-of-study follow-up
Lasso di tempo: 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)
|
Collaboratori e investigatori
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Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 88454
- K24DA053564 (Sovvenzione/contratto NIH degli Stati Uniti)
- R90HD118650 (Sovvenzione/contratto NIH degli Stati Uniti)
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