Health TrialsbyHealthPanel

Reducing Chronic Pain Following Cesarean Delivery

ConditionsChronic PainCesarean Section ComplicationsPostpartum
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorStanford University

About this trial

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.

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.

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.

Trial design

Design model

Single group

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

30 Participants
are divided into 1 treatment group
Group A: Empowered ReliefExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of enrolled patients that complete the Empowered Relief session

The proportion of enrolled patients that complete the single 120-minute Empowered Relief session.

Time frame
Within 2 weeks of enrollment

Secondary outcomes

1

Proportion of screened patients who are eligible for the study

The proportion of screened patients that meet the study eligibility criteria.

Time frame
During screening, at approximately 6 weeks postpartum
2

Proportion of eligible patients that consent to study from those approached

The proportion of eligible patients who provide informed consent and enroll in the study.

Time frame
During screening and enrollment, at approximately 6 weeks postpartum
3

Proportion of recruited patients who register for the Empowered Relief session

The proportion of recruited patients who register for the Empowered Relief session.

Time frame
Within 1 week of enrollment
4

Proportion of recruited patients who attend the Empowered Relief session

The proportion of recruited patients who attend an Empowered Relief session.

Time frame
Within 2 weeks of baseline

Other outcomes

Sponsors and contacts

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

Stanford University

Lead sponsor

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

Collaborator

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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