Self-Hypnotic Relaxation Therapy During Invasive Procedures
Primary Purpose
Uterine Neoplasms, Leiomyoma
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Self-hypnotic relaxation
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Neoplasms focused on measuring Hypnosis, Analgesia, Embolization, Therapeutic, Chemoembolization, Therapeutic
Eligibility Criteria
Inclusion Criteria: Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors Able to hear and understand English Exclusion Criteria: Impaired mental function Psychosis Severe chronic obstructive pulmonary disease Intolerance of midazolam or fentanyl Weigh less than 121 lbs Pregnancy
Sites / Locations
- Beth Israel Deaconess Medical Center
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00087841
First Posted
July 14, 2004
Last Updated
January 15, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
1. Study Identification
Unique Protocol Identification Number
NCT00087841
Brief Title
Self-Hypnotic Relaxation Therapy During Invasive Procedures
Official Title
Midcareer Development of Nonpharmacologic Analgesia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2008
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)
4. Oversight
5. Study Description
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 with the ongoing procedure and may negatively impact future interventions.
Studies have shown that nonpharmacologic analgesia in the form of self-hypnotic relaxation during invasive medical procedures significantly reduces patients' pain, anxiety, drug use, and number of complications. The long-term goal of this study is to determine whether self-hypnotic relaxation therapy can be a safe and practical method for reducing cognitive and physiologic distress associated with invasive procedures.
Participants in this study will be randomly assigned to one of three groups: a standard care group, an empathic control group, and a self-hypnotic relaxation group. The emphatic control group will meet with a clinician who will offer encouragement and support. The group assigned to self-hypnotic relaxation will read a standardized script prior to procedure. Self-report questionnaires will be used to assess pain and anxiety.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Neoplasms, Leiomyoma
Keywords
Hypnosis, Analgesia, Embolization, Therapeutic, Chemoembolization, Therapeutic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
390 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Self-hypnotic relaxation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Referred for transcatheter embolization for benign uterine fibroid tumor or radiofrequency ablation or chemoembolization for malignant tumors
Able to hear and understand English
Exclusion Criteria:
Impaired mental function
Psychosis
Severe chronic obstructive pulmonary disease
Intolerance of midazolam or fentanyl
Weigh less than 121 lbs
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elvira Lang, MD
Organizational Affiliation
Beth Israel Deaconess Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Self-Hypnotic Relaxation Therapy During Invasive Procedures
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