Obstetrical Procedures Statistics |
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Clinical Trial: Self-hypnotic Relaxation Therapy During Invasive Procedures
This study is currently recruiting patients.
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Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Uterine Neoplasms Leiomyoma | Behavior: Self-hypnotic relaxation | Phase II |
MedlinePlus related topics: Uterine Cancer; Uterine Fibroids
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: Midcareer Development of Nonpharmacologic Analgesia
Expected Total Enrollment: 390
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.
Eligibility
Ages Eligible for Study: 18 Years - 90 Years, Genders Eligible for Study: Both
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
Location and Contact Information
Massachusetts
Beth Israel Deaconess Medical Center, Boston, Massachusetts, 02215, United States; Recruiting
Elvira V. Lang, MD 617-754-2847 elang@bidmc.harvard.edu
Elvira V. Lang, MD, Principal Investigator
Rhode Island
Rhode Island Hospital, Providence, Rhode Island, 02903, United States; Recruiting
More Information
Record last reviewed: February 2005
Last Updated: February 10, 2005
Record first received: July 14, 2004
ClinicalTrials.gov Identifier: NCT00087841
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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