Using hypnosis to reduce opioid use during breast cancer surgery
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
This study is testing whether using hypnosis during breast cancer surgery can help reduce the need for opioids compared to standard anesthesia.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 225 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT05766891 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of nurse-delivered hypnosis (HS) in reducing opioid consumption during and after breast cancer surgery compared to standard general anesthesia (GA). Participants will be randomized into three groups: one receiving HS with local anesthesia, another receiving HS with GA, and a control group receiving only GA. The study will assess pain levels, psychological stress, recovery times, and overall costs associated with each approach. The goal is to determine if HS can provide a safer, more effective alternative to traditional opioid use in surgical settings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older diagnosed with stage 0/I breast cancer scheduled for specific surgical procedures.
Not a fit: Patients with chronic opioid use, severe mobility issues, or certain psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce opioid use and improve recovery outcomes for patients undergoing breast cancer surgery.
How similar studies have performed: Previous studies have shown promising results with hypnosis in surgical settings, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Men and Women; 2. Age 18 or older; 3. Scheduled for a unilateral, breast surgical procedure, ± SLND 4. Able to read, write and speak English or Spanish 5. Able to sign a written informed consent and be willing to follow protocol requirements Exclusion Criteria: 1. Extreme mobility issues that preclude participating in the study 2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD 3. History of chronic opioid use 4. Current pain 2 or above on 0-10 scale 5. Co-mobilities such as uncontrollable diabetes or hypertension 6. Plastic surgery involvement for oncoplastic reconstruction 7. Have undergone chemotherapy for current breast cancer diagnosis 8. Surgery is likely greater than 3 hours 9. Patients with hearing loss that could preclude HS facilitation 10. Known allergy to propofol or other medications used during surgery
Where this trial is running
Houston, Texas
- M D Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Lorenzo Cohen, MD — M.D. Anderson Cancer Center
- Study coordinator: Lorenzo Cohen, MD
- Email: lcohen@mdanderson.org
- Phone: (713) 745-4260
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.