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Midcareer Development of Nonpharmacologic Analgesia


Phase 2
18 Years
90 Years
Not Enrolling
Both
Uterine Neoplasms, Leiomyoma

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Trial Information

Midcareer Development of Nonpharmacologic Analgesia


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Elvira Lang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Beth Israel Deaconess Medical Center

Authority:

United States: Federal Government

Study ID:

K24 AT001074-01

NCT ID:

NCT00087841

Start Date:

April 2002

Completion Date:

November 2006

Related Keywords:

  • Uterine Neoplasms
  • Leiomyoma
  • Hypnosis
  • Analgesia
  • Embolization, Therapeutic
  • Chemoembolization, Therapeutic
  • Neoplasms
  • Leiomyoma
  • Myofibroma
  • Uterine Neoplasms

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215