Self-Hypnotic Relaxation Therapy During Invasive Procedures - Tabular View

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Self-Hypnotic Relaxation Therapy During Invasive Procedures

This study has been completed.
Information provided by National Center for Complementary and Alternative Medicine (NCCAM)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Self-Hypnotic Relaxation Therapy During Invasive Procedures

Official Title ^†

Midcareer Development of Nonpharmacologic Analgesia

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Uterine Neoplasms
Leiomyoma

Intervention ^†

Behavioral: Self-hypnotic relaxation

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

390

Start Date ^†

April 2002

Completion Date

November 2006

Eligibility 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

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00087841

Organization ID

K24 AT001074-01

Secondary IDs ^††

Study Sponsor ^†

National Center for Complementary and Alternative Medicine (NCCAM)

Collaborators ^††

Investigators ^†

Principal Investigator:

Elvira Lang, MD

Beth Israel Deaconess Medical Center

Information Provided By

National Center for Complementary and Alternative Medicine (NCCAM)

Verification Date

January 2008

First Received Date ^†

July 14, 2004

Last Updated Date

January 15, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.