Pelvic Pain Clinical Trial
Official title:
Pilot Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With Interstitial Cystitis
Interstitial cystitis (IC) affects more than one million women in the United States. It has
been thought that IC patients who have been unable to obtain adequate relief from medical
remedies would value a psychotherapeutic intervention that could diminish some of their
pain.
There are currently no studies using biomarkers with the use of a relaxation technique
called guided imagery in IC patients. Many guided imagery intervention studies in areas such
as cancer, post-operative pain, and arthritis reported that guided imagery resulted in
improvements in the psychological or physiological outcomes examined. If this is also true
in IC patients, this intervention may prevent the use of unnecessary medications and
procedures that are currently being used.
This is a randomized pilot study. Women who are referred to the Nurse Practitioner for
treatment will be invited to enroll. If the patient meets the study criteria, the study will
be explained. If the patient agrees to participate in this study, informed consent will be
obtained. The patient will be randomized (similar to flipping a coin) into either the
Treatment group or Control group. Both groups will be maintained with their IC regimens as
prescribed by their own health care providers. The following actions and treatment will
done:
There will be 2 visits for all subjects. All subjects will complete a pain diary and
medication log during the study. Salivary samples will be obtained at baseline, during the
first week of the study, after the 2nd week of the study, the midpoint of the intervention
(week 3) and at the end of the study. The Treatment group will listen to a guided imagery CD
twice a day, and the Control group will sit or lay down, doing whatever they choose, for the
same length of time twice a day. All subjects will complete questionnaires upon enrollment
and at week 6.The "Treatment" subjects will receive the guided imagery CD specific for
pelvic pain and interstitial cystitis. After the baseline data is completed, they will
listen to track 2 of the CD (25 min. in length) twice a day ("Relaxation Exercise A"). The
first week they listen to the CD, for 3 days they will obtain salivary tests upon waking
then ½ hour later. Then they will listen to the CD, and obtain another salivary sample in
addition to recording their pulse and respirations immediately after listening to the CD.
The bedtime salivary test, pulse and respirations will be done immediately after listening
to the CD. Salivary testing, pulse and respirations will also be done before this evening CD
session. The salivary testing will be repeated in the same fashion during the 3rd week of
intervention.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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