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Self-Hypnotic Relaxation Therapy During Invasive Procedures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00087841
First Posted: July 16, 2004
Last Update Posted: January 17, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)
  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 Intervention Phase
Uterine Neoplasms Leiomyoma Behavioral: Self-hypnotic relaxation Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Midcareer Development of Nonpharmacologic Analgesia

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

Estimated Enrollment: 390
Study Start Date: April 2002
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087841


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Elvira Lang, MD Beth Israel Deaconess Medical Center
  More Information

ClinicalTrials.gov Identifier: NCT00087841     History of Changes
Other Study ID Numbers: K24AT001074-01 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2004
First Posted: July 16, 2004
Last Update Posted: January 17, 2008
Last Verified: January 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Hypnosis
Analgesia
Embolization, Therapeutic
Chemoembolization, Therapeutic

Additional relevant MeSH terms:
Leiomyoma
Uterine Neoplasms
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs