Chronic PainNCT07090018
Empowered Relief: A One-Time Session to Help Postpartum Women Manage Ongoing Pain After Cesarean Delivery
A study testing Empowered Relief in people with Chronic Pain and Cesarean Section Complications, run by Stanford University at 1 site in United States.
Trial summary
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Chronic Pain, Cesarean Section Complications
- What is being tested?
- Empowered Relief
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Sep 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females 18 years of age or older
- Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
- has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum
- English fluency
- Ability to adhere to and complete study protocols
- Access to smart device for zoom / video meetings
Who cannot join
- <18yrs
- Chronic pain prior to pregnancy
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery.
- Conditions
- Chronic Pain, Cesarean Section Complications
- Being tested
- Empowered Relief
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowered ReliefBehavioural
Also called 1-Session Pain Relief Skills Intervention
The participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use.
| Study group | Role | What they receive |
|---|---|---|
| 1-Session pain relief skills session (Empowered Relief) | Experimental | Participants will attend an Empowered Relief session at the beginning of the study period.
Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use.
Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider Receives: Behavioral: Empowered Relief |
| Control arm: Postpartum Standard of Care | No intervention | Participants will follow their current standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants registering for Empowered Relief session
Measured: Baseline (up to 1 week)
Percentage of participants attending Empowered Relief session
Measured: Treatment (up to 2 weeks)
Participant Satisfaction Scale Score
Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).
Measured: 1 - 2 weeks Post treatment
Participant Treatment Skills Use Scale Score
Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
Measured: 4 - 6 weeks Post Treatment
Secondary outcomes (7)
Change from baseline in PROMIS Pain Interference 8a scale score
Participants complete Patient Reported Outcomes Measurement Outcomes System (PROMIS) Pain Interference 8a questionnaire, an 8-item scale assessing pain interference with life enjoyment, concentration, and daily activities over the past 7 days.
(Score range 8 - 40, higher scores represent a greater degree of pain interference).
Measured: Baseline, Week 6
Change from baseline in PROMIS Pain Intensity 3a scale score
Participants complete PROMIS Pain Intensity 3a questionnaire, a 3-item scale assessing average pain intensity for the past 7 days.
(Score range 3 - 15, higher score represents a greater degree of pain intensity)
Measured: Baseline, Week 6
Change from baseline in Pain Catastrophizing Scale Score
Participants complete Pain Catastrophizing questionnaire, a 13-item scale assessing an individual's pain experience
(Score range 0 - 52, higher score represents a greater degree of pain catastrophizing)
Measured: Baseline, Week 6
Change from baseline in PEG scale score (composite)
Participants complete thrice weekly Pain, Enjoyment, General Activity Scale (PEG) questionnaire, a 3-item scale assessing pain interference and intensity via SMS.
(Score range 0 - 30, higher score represents a greater degree of pain intensity/interference)
Measured: From enrollment to the end of study completion at 6 weeks
Change from baseline in PEG scale score (pain interference)
Participants complete thrice weekly PEG questionnaire, to assess pain interference via SMS.
(Score range 0 - 20, higher score represents a greater degree of interference)
Measured: From enrollment to the end of study completion at 6 weeks
Change from baseline in PEG scale score (pain intensity)
Participants complete thrice weekly PEG questionnaire to assess pain intensity, via SMS.
(Score range 0 - 10, higher score represents a greater degree of pain intensity)
Measured: From enrollment to the end of study completion at 6 weeks
Response rate to individual items of the PEG scale score via SMS
Participant percentage responding to items of the thrice weekly PEG questionnaire, a 3-item scale assessing pain interference and intensity via SMS.
(Score range 0 - 3; higher scores indicate higher response rate)
Measured: From enrollment to the end of study completion at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start25 Sep 2025
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Why it stopped: unable to enroll participants with current study design
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Pervez Sultan, Stanford University
- Investigators
- Pervez Sultan, MBChB, FRCA, MD(Res), Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090018
- Sponsor's protocol ID
- 80475
- Other IDs
- 1R90HD118650
- Status last verified
- Sep 2026
- First submitted
- 22 Jul 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Publications
Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24.
PubMed 40279839
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Feasibility Trial for an Intervention to Reduce Chronic Pain Following Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07090018
- Acronym / sponsor ID
- 80475
- Conditions
- Chronic Pain, Cesarean Section Complications
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: unable to enroll participants with current study design
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 25 Sep 2025 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to study the effect of a pain relief skills session (Empowered Relief) on chronic pain incidence at 12 weeks post cesarean delivery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1-Session pain relief skills session (Empowered Relief) | Experimental | Behavioral: Empowered ReliefParticipants will attend an Empowered Relief session at the beginning of the study period. Empowered Relief is a 2-hour one session pain relief skills intervention that is delivered to patients by a certified instructor using a standardized treatment manual and slide deck. Content includes completion of a pain survey, pain neuroscience education, information on pain and stress responses, experiential exercises, information on three core pain management skills, completion of a personalized plan for empowered relief, and receipt of a binaural app for daily use. Standard of care will be maintained for all participants, and supplemented with Empowered Relief. Pain management is not a factor for inclusion/exclusion criteria and patients will continue their pain management as prescribed and directed by their provider |
| Control arm: Postpartum Standard of Care | No intervention | –Participants will follow their current standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Females 18 years of age or older
- Any postpartum woman who has had a cesarean delivery in the Stanford Healthcare system with a viable birth
- has moderate/severe pain, scoring ≥ 4/10 on the numerical/visual analog scale that continues at 6 weeks postpartum
- English fluency
- Ability to adhere to and complete study protocols
Key exclusion criteria (3 listed)
- <18yrs
- Chronic pain prior to pregnancy
- Cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material and/or full participation in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowered ReliefAlso: 1-Session Pain Relief Skills InterventionThe participants will attend a pain relief skills intervention (Empowered Relief). The two-hour session is delivered by a certified instructor and includes pain neuroscience education, 3 core pain management skills, experiential exercises, completion of a personalized plan for empowered relief. Participants download a binaural relaxation audio file for daily use. | Behavioural | 1-Session pain relief skills session (Empowered Relief) |
Primary outcome
Percentage of participants registering for Empowered Relief session
Time frame: Baseline (up to 1 week)
Percentage of participants attending Empowered Relief session
Time frame: Treatment (up to 2 weeks)
Participant Satisfaction Scale Score
Time frame: 1 - 2 weeks Post treatment
Participant satisfaction will be measured using a 7 item questionnaire (scale ranges from 0 - 42, higher ratings represent greater satisfaction with the treatment).
Participant Treatment Skills Use Scale Score
Time frame: 4 - 6 weeks Post Treatment
Participant treatment skills use will be measured with a 5 items questionnaire (scale ranges from 0 - 25, higher ratings represent increased time using treatment).
7 secondary outcomes
Change from baseline in PROMIS Pain Interference 8a scale score
Time frame: Baseline, Week 6
Change from baseline in PROMIS Pain Intensity 3a scale score
Time frame: Baseline, Week 6
Change from baseline in Pain Catastrophizing Scale Score
Time frame: Baseline, Week 6
Change from baseline in PEG scale score (composite)
Time frame: From enrollment to the end of study completion at 6 weeks
Change from baseline in PEG scale score (pain interference)
Time frame: From enrollment to the end of study completion at 6 weeks
Change from baseline in PEG scale score (pain intensity)
Time frame: From enrollment to the end of study completion at 6 weeks
Response rate to individual items of the PEG scale score via SMS
Time frame: From enrollment to the end of study completion at 6 weeks
Results and safety
The study was stopped early (reason given: unable to enroll participants with current study design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 40279839Ciechanowicz S, Joy RR, Kasmirski J, Blake L, Carvalho B, Sultan P. Incidence, Severity, and Interference of Chronic Postsurgical Pain After Cesarean Delivery: A Systematic Review and Meta-analysis. J Clin Anesth. 2025 Jun;104:111832. doi: 10.1016/j.jclinane.2025.111832. Epub 2025 Apr 24.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pervez Sultan, MBChB, FRCA, MD(Res) principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowered Relief in people with Chronic Pain and Cesarean Section Complications, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: unable to enroll participants with current study design). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants registering for Empowered Relief session (time frame: Baseline (up to 1 week)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07090018, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.