Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00420550
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2007-01-09
Brief Title:
Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With IC
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Pilot Study of Biomarkers and the Relaxation Response Using Guided Imagery in Women With Interstitial Cystitis
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
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 6The 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
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 6The 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None