Pelvic Pain Clinical Trial
Official title:
Restoring Emotional, Sexual, and Physical Empowerment Through CBT & Trauma-sensitive Care: A Chronic Pelvic Pain Intervention
This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Patients will be recruited after being referred to pelvic floor physical therapy for treatment of chronic pelvic pain. Participants will complete seven sessions of individual cognitive behavioral psychotherapy. Physical therapy will be provided by clinicians who have been trained in trauma-sensitive treatment techniques. Treatment acceptability and outcomes will be assessed at baseline, mid intervention, post-intervention and follow-up via self-report measures. The RESPECT protocol is expected to be feasible to implement among sexual abuse survivors and to be well liked by patients. RESPECT is expected to reduce chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance.
This project will develop and preliminarily examine RESPECT, a trauma-sensitive psychological and physical therapy intervention to treat chronic pelvic pain, posttraumatic stress symptoms (PTS), and dysfunctional sexual behavior among women with sexual abuse histories. Chronic pelvic pain disorders are highly prevalent in the U.S., affecting between 10-21% of premenopausal women at some time in their lives. Chronic pelvic pain is associated with dyspareunia, depression, anxiety, relationship distress, functional impairment and poor quality of life. History of sexual abuse is associated with development of chronic pelvic pain and with the severity of psychological distress and functional impairment among chronic pain patients. Unfortunately, frontline chronic pelvic pain treatments such as physical therapy and pain-specific psychological interventions fail to address sexual trauma. Standard physical therapy may actually trigger trauma related symptoms because it involves invasive techniques including internal digital palpation of pelvic floor muscles and the use of vaginal dilators. Neglecting trauma in chronic pelvic pain treatment could contribute to poor treatment outcomes, low adherence, and drop out. RESPECT's trauma-sensitive psychological intervention will teach women skills to cope with PTS, pain, sexual dysfunction, and discomfort during physical therapy. RESPECT's trauma-sensitive physical therapy intervention will more sensitively apply the invasive aspects of treatment and reinforce women's use of trauma-related coping skills learned in the psychological intervention. RESPECT is predicted to decrease chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance. Study Aims 1. Develop a multi-level trauma-sensitive (psychological and physical therapy) chronic pelvic pain intervention for inner-city women with histories of sexual abuse and PTS symptoms. 2. Examine the feasibility of RESPECT in treating this population. 3. Use a pilot open trial to examine the impact of RESPECT chronic pelvic pain, PTS, dysfunctional sexual behavior, treatment avoidance. RESPECT's trauma-sensitive psychological intervention will 1) educate the patient about the relations between sexual abuse, PTS, and chronic pelvic pain 2) empower her by explaining that sexual abuse, chronic pelvic pain, and PTS are not her fault but she has the power to combat them 3) desensitize her to anxiety provoking components of the physical therapy intervention, and 4) teach her relaxation tools that she can use during physical therapy sessions, while practicing at-home physical therapy exercises, and to cope with pain more generally. RESPECT's trauma-sensitive physical therapy intervention will 1) teach the patient techniques to address muscular tension that contributes to chronic pelvic pain 2) empower her by increasing her control over each phase of treatment (e.g., starting, stopping, expressing feelings and preferences) 3) comfort her by explaining that it is normal to experience discomfort during physical therapy treatment and 4) encourage her to use the trauma-related coping skills she learned in the psychotherapy component. This initial project is intended to lead to a larger open trial that will examine not only treatment outcomes, but also the mechanisms of change (e.g., women's feeling of empowerment, decrease in PTS symptoms). ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04077801 -
Effect Of Chronic Pelvic Pain on Lumbopelvic Alignment And TemproMandibular Joint Kinematics in Women
|
||
Completed |
NCT03740932 -
Effect of Biomechanical Alignment and Jaw on Women With Pelvic Pain
|
||
Completed |
NCT04081532 -
The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain
|
N/A | |
Recruiting |
NCT06101303 -
Endometriosis Pain
|
||
Recruiting |
NCT03868137 -
Multi-dose Ibuprofen Prophylaxis for IUD-insertion
|
N/A | |
Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
Completed |
NCT02547857 -
Transvaginal Pelvic Ultrasound in the ED
|
N/A | |
Completed |
NCT02923245 -
POCUS Assessment of Bladder Fullness for Girls Awaiting Radiology-Performed Transabdominal Pelvic Ultrasound
|
N/A | |
Completed |
NCT01938092 -
Vaginal Diazepam for the Treatment of Female Pelvic Pain
|
Phase 2 | |
Active, not recruiting |
NCT01731470 -
Intravesical Liposomes for Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS)
|
N/A | |
Completed |
NCT01421641 -
Tenaculum Pain Control Study
|
Phase 4 | |
Completed |
NCT00034047 -
Endometriosis : Traditional Medicine vs Hormone Therapy
|
Phase 1/Phase 2 | |
Completed |
NCT05368155 -
Chronic Pelvic Pain and Education Skills Training for Women Veterans
|
N/A | |
Completed |
NCT04179149 -
Enriched Environments in Endometriosis
|
N/A | |
Not yet recruiting |
NCT05530681 -
Correlation Pelvic Floor Function and Ultrasound Findings One Year After Childbirth
|
N/A | |
Completed |
NCT04077775 -
Temporomandibular Joint Kinematics Changes in Pregnant Women: A Case-control Study
|
||
Completed |
NCT03715777 -
Electromyographic Study for the Help and Guidance of BoNTA Administration in the Treatment of Chronic Pelvic Floor Pain
|
Phase 3 | |
Recruiting |
NCT05926752 -
Photobiomodulation for Myofascial Pelvic Pain
|
N/A | |
Completed |
NCT02261740 -
Program to Overcome Pelvic Pain With Yoga
|
N/A | |
Completed |
NCT02259712 -
Effectiveness of Hypopressive Exercises Versus Pelvic-perineal Physiotherapy
|
N/A |