Self-Hypnotic Relaxation Therapy During Invasive Procedures - Full Text View

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 II

MedlinePlus related topics:

Cancer Uterine Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Official Title:	Midcareer Development of Nonpharmacologic Analgesia

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

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

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087841

Locations


United States, Massachusetts
	Beth Israel Deaconess Medical Center
	Boston, Massachusetts, United States, 02215

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

Investigators


Principal Investigator:	Elvira Lang, MD	Beth Israel Deaconess Medical Center

More Information

Study ID Numbers:	K24 AT001074-01
First Received:	July 14, 2004
Last Updated:	January 15, 2008
ClinicalTrials.gov Identifier:	NCT00087841
Health Authority:	United States: Federal Government

Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):

Hypnosis

Analgesia

Embolization, Therapeutic

Chemoembolization, Therapeutic

Study placed in the following topic categories:

Genital Diseases, Female

Neoplasms, Connective and Soft Tissue

Myofibroma

Genital Neoplasms, Female

Uterine Diseases

Uterine Neoplasms

Urogenital Neoplasms

Leiomyoma

Additional relevant MeSH terms:

Neoplasms, Muscle Tissue

Neoplasms

Neoplasms by Site

Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on August 28, 2008

Sponsored by:	National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by:	National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:	NCT00087841