Self-Hypnotic Relaxation Therapy During Invasive Procedures

Phase 2

Completed

• Conditions: Uterine Neoplasms; Leiomyoma

• Registration Number: NCT00087841
• Lead Sponsor: National Center for Complementary and Integrative Health (NCCIH)

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.

Study Timeline

• Study Start: 2002-04
• Study First Submitted: 2004-07-14
• Study First Submitted QC: 2004-07-15
• Study First Posted: 2004-07-16
• Primary Completion: 2006-11
• Study Completion: 2006-11
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-15
• Last Update Posted: 2008-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Boston, Massachusetts, United States