Status:
COMPLETED
Self-Hypnotic Relaxation Therapy During Invasive Procedures
Lead Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Uterine Neoplasms
Leiomyoma
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effectiveness of self-hypnotic relaxation on mental and physical distress during and after tumor treatment procedures.
Detailed Description
Pain relievers and sedatives may have limited effectiveness and serious side effects when given to alleviate distress during minimally invasive surgical procedures. Unabated distress may interfere wit...
Eligibility Criteria
Inclusion
- Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors
- Able to hear and understand English
Exclusion
- Impaired mental function
- Psychosis
- Severe chronic obstructive pulmonary disease
- Intolerance of midazolam or fentanyl
- Weigh less than 121 lbs
- Pregnancy
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT00087841
Start Date
April 1 2002
End Date
November 1 2006
Last Update
January 17 2008
Active Locations (1)
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1
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215