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

ConditionsSevere PainCesarean Section ComplicationsPostpartumChronic PainAcute Postoperative Pain
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Empowered ReliefExperimental treatment 1 intervention
Group B: Standard Postpartum CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Proportion of enrolled participants randomized to the ER intervention who complete the 120-minute ER session 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.

Time frame
Day 1 ± 5 days, during the inpatient postpartum period

Secondary outcomes

1

Proportion of screened patients who are eligible for the study

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.

Time frame
At screening
2

Proportion of eligible patients that consent to study from those approached

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.

Time frame
Baseline (Day 1)
3

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

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.

Time frame
Day 1 ± 5 days, during the inpatient postpartum period
4

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

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.

Time frame
Day 1 ± 5 days, during the inpatient postpartum period

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Stanford University

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: