Expired Study
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Boston, Massachusetts 02215


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.


Study summary:

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.


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


Study is Available At:


Original ID:

K24 AT001074-01


NCT ID:

NCT00087841


Secondary ID:


Study Acronym:


Brief Title:

Self-Hypnotic Relaxation Therapy During Invasive Procedures


Official Title:

Midcareer Development of Nonpharmacologic Analgesia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

90 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Center for Complementary and Alternative Medicine (NCCAM)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

390


Enrollment Type:


Overall Contact Information

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

Study Dates

Start Date:April 2002
Completion Date:November 2006
Completion Type:Actual
Primary Completion Date:November 2006
Primary Completion Type:Actual
Verification Date:January 2008
Last Changed Date:January 15, 2008
First Received Date:July 14, 2004

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Behavioral
Name:Self-hypnotic relaxation

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Complementary and Alternative Medicine (NCCAM)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

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