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NCT Number: NCT07832240

Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94304, United States

Location contact

Guillermina Ferrea, MD, MSc

CONTACT

[email protected]

(650) 457-7704

About this study

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 more than 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 more than 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.

Treatment and study plan

Empowered Relief

Behavioral

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).

Primary outcomes

  1. Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session during the inpatient postpartum period

    Time frame: 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.

Secondary outcomes

  1. Proportion of screened patients who are eligible for the study

    Time frame: 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.

  2. Proportion of eligible patients that consent to study from those approached

    Time frame: 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.

  3. Proportion of recruited patients randomized to the ER intervention arm who register for the ER session

    Time frame: 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.

  4. Proportion of recruited patients randomized to the ER intervention arm who attend the ER session

    Time frame: 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.

  5. Treatment Appraisal score (intervention arm)

    Time frame: 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.

  6. Qualitative feedback regarding the ER intervention (intervention arm)

    Time frame: 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 included in the Treatment Appraisal Questionnaire.

  7. Participant Treatment Skills Use Scale score (intervention arm)

    Time frame: 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.

  8. Adherence to study procedures: Completion rate of scheduled surveys

    Time frame: From enrollment through end-of-study (12-week follow-up)

    The percentage of scheduled study surveys completed by enrolled participants.

  9. Adherence to study procedures: Completion rate of scheduled repeated Pain, Enjoyment, General Activity (PEG) assessments

    Time frame: 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.

  10. Adherence to study procedures: Participant retention through end-of-study follow-up

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillermina Ferrea, MD, MSc

CONTACT

[email protected]

(650) 457-7704

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

A Single-Session Pain Management Intervention for Severe Pain After Cesarean Delivery: A Pilot Feasibility Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 21, 2026
Registry last updated
Sep 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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