Clinical trial · Interventional
Hypnosedation in Relaxing Patients Undergoing Breast Cancer Surgery
Biobehavioral Effects of Hypnosis During Breast Cancer Surgery
NCT03012399CI-TRIAL-00104721active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 15, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260915-000001
Summary
Brief summary (as posted)
This clinical trial studies how well hypnosedation works in relaxing and reducing the need for general anesthesia in patients who are undergoing breast cancer surgery. Hypnosedation is a technique that places patients under conscious sedation where they remain awake and numbed during surgery and involves the use of words and images to help patients relax and to affect their thoughts about what is happening during surgery.
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anatomic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Anatomic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage 0 Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IA Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage IB Breast Cancer AJCC v8 | — | UNRESOLVED | — |
| Prognostic Stage I Breast Cancer AJCC v8 | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypnosedation | Behavioral | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Verbal Support | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (hypnosedation)
- description
- Patients undergo hypnosedation performed by a mind-body specialist before surgery begins and continuing until after surgery is complete.
- interventionNames
- Behavioral: Hypnosedation
- Other: Questionnaire Administration
- type
- ACTIVE_COMPARATOR
- label
- Group II (verbal support)
- description
- Patients speak to a mind-body specialist before surgery and prior to receiving general anesthesia.
- interventionNames
- Other: Questionnaire Administration
- Behavioral: Verbal Support
Primary outcomes (1)
- measure
- Hypnosedation (HS) feasibility
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female clinical stage 0/1 breast cancers patients scheduled to undergo a unilateral, segmental mastectomy +/- sentinel lymph node dissection * Able to read, speak, and write English or Spanish Exclusion Criteria: * A significant anxiety disorder * Significant pain during core biopsy as reported by the patient * Received neoadjuvant chemotherapy, any autoimmune or immunological disease or taking any immune suppression drugs * Plastic surgery involvement for oncoplastic reconstruction * If surgery is likely greater than 3 hours
References
Publications (0)
Data not yet available
No reference posted for this study.