Self-Hypnotic Relaxation Therapy During Invasive Procedures
|ClinicalTrials.gov Identifier: NCT00087841|
Recruitment Status : Completed
First Posted : July 16, 2004
Last Update Posted : January 17, 2008
|Condition or disease||Intervention/treatment||Phase|
|Uterine Neoplasms Leiomyoma||Behavioral: Self-hypnotic relaxation||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||390 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Midcareer Development of Nonpharmacologic Analgesia|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||November 2006|
|Actual Study Completion Date :||November 2006|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087841
|United States, Massachusetts|
|Beth Israel Deaconess Medical Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Elvira Lang, MD||Beth Israel Deaconess Medical Center|