Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With IC

March 19, 2012 updated by: William Beaumont Hospitals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Established diagnosed IC patient
  • Women at least 18 years of age
  • Self reported pelvic pain
  • Capable of giving informed consent
  • Capable and willing to follow all study related procedures (e.g. keep voiding diary, pain diary, complete questionnaires, listening to CD, obtaining salivary samples).
  • Participants must have a stable medication regimen.
  • Neuromodulation (if present) must stay stable throughout the study.

Exclusion Criteria:

  • Currently participating or have participated within the past 30 days in any clinical investigation involving or impacting urinary or renal function. Patients with neuromodulation devices are excluded for the first 3 months after insertion of the device.
  • Use of this guided imagery CD within the past 30 days.
  • Diagnosed depression
  • Pregnancy or intending to become pregnant during the study
  • Cannot independently comprehend and complete the questionnaires.
  • The subject is deemed unsuitable for enrollment in this study by the investigators based on their history.
  • Men are excluded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of IC symptoms. Overall improvement will be quantified by a Global Response Assessment.

Secondary Outcome Measures

Outcome Measure
Bladder symptoms will be assessed by completion of a voiding diary and the Interstitial Cystitis Symptom Index and Problem Index (IC-SIPI) (36) pre- and post- study intervention.
Pain will be measured by a Visual Analog Scale (VAS)
The Relaxation Response will be evaluated by salivary cortisol, alpha amylase and IL-6 levels (all biomarkers), pulse, and respiratory rate.d.) Overall health and well-being will be assessed by the SF-12 (37).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

William Beaumont Hospitals

Investigators

  • Principal Investigator: Kenneth Peters, M.D., William Beaumont Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

January 9, 2007

First Submitted That Met QC Criteria

January 9, 2007

First Posted (Estimate)

January 11, 2007

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006-188

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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