Trial Information

Self Hypnotic Relaxation As An Adjunct To Local Anesthesia During Large Core Breast Biopsy

Large core image-guided breast biopsy is a well established tool for diagnosing breast
cancer. Using ultrasound or X-ray guidance, a large hollow needle is inserted through the
skin into the breast and abnormal tissue is removed for diagnosis. Although this procedure
is much less invasive than open surgery, it can induce pain and anxiety that can tax the
coping mechanism of even the highest functioning individuals. Unrelieved stress during a
medical procedure not only interferes with smooth progression of the ongoing procedure, but
can also have deleterious effects when patients need additional procedures and feel dread
in anticipation. The long-term objective of this research is to provide patients with a
simple coping strategy at the time of large core biopsy, when they need it most. The hope is
that this newly learned ability to handle distress will carry over to recovery and to
future medical procedures. In a prior clinical trial (Lancet 2000:335:1486-1489), the
largest prospective randomized study of its kind, the researchers showed that a
self-hypnotic intervention during image-guided interventions of the blood vessels and the
kidneys resulted in less pain and anxiety, fewer worrisome increases and decreases of blood
pressure and heart rate, and fewer procedure interruptions. The positive effects of the
short initial hypnotic intervention, which was structured in the procedure room, became more
pronounced the longer the procedure lasted and carried over into the immediate
post-procedure recovery. Based on these past findings, the researchers therefore predict to
show evidence contrary to the current thinking that long-lasting effects require intensive
presurgical preparation.

The researchers propose to pursue three interrelated specific aims:

- (Aim 1): Determine the acute effects of self-hypnotic relaxation on pain and anxiety.
Strictly defined methods of self-hypnotic relaxation (Group I), will be tested against
empathic attention (Group II) and the routine standard of care (Group III) in a
prospective randomized study with 240 patients undergoing large core breast biopsy. The
impact of the treatment will be validated by comparing during the procedure among
groups subjective measures of pain and anxiety as well as objective physiologic
indicators of pain and anxiety (frequency of significant increases in heart rate and
blood pressure).

- (Aim 2): Determine the delayed effects of self-hypnotic relaxation. Patients' levels
of pain, anxiety, and stress will be recorded through days 1-5 after the biopsy and
compared among groups. Stress levels measurements will be based on an objective test
(the amount of the stress hormone cortisol in the patient's saliva).

- (Aim 3): Determine the effect of the initial self-hypnotic relaxation on distress with
upcoming subsequent surgery in women with proven breast cancer. When patients have to
return for surgery because their biopsy revealed malignant cells, they will be given
questionnaires assessing their degree of perceived stress , anxiety, and preoccupation
with their upcoming surgery. Comparison among groups will show the durability of the
initial hypnotic intervention.

The researchers hypothesize that:

- Self-hypnotic relaxation reduces pain and anxiety during large core breast biopsy

- Self-hypnotic relaxation at the time of biopsy reduces post-biopsy stress

- Teaching patients coping skills at the critical time of the breast biopsy reduces the
patients' distress with upcoming breast surgery.

Upon completion, a short periprocedural self-hypnotic intervention will be validated by
rigorous and practical assessment in 240 patients. The relative performance of
self-hypnotic relaxation will be known compared to standard care and empathic controls in a
well-characterized population of patients with a standardized biopsy wound. The durability
of an intervention given at the earliest possible moment of breast cancer diagnosis will be
established. This opens the way to future study designs addressing long-term effects on
health behavior and psycho-physiologic phenomena.