Effects of Depression and Anxiety for Pelvic Organ Prolapse
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Purpose
The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.
- Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
- Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.
A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.
| Condition |
|---|
|
Pelvic Organ Prolapse |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Effects of Depression and Anxiety on Perioperative Outcomes Following Surgery for Pelvic Organ Prolapse |
- Perioperative complications [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Analgesic use [ Time Frame: 1 week ] [ Designated as safety issue: No ]
- Length of hospital stay [ Time Frame: 1 week ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 334 |
| Study Start Date: | September 2011 |
| Estimated Study Completion Date: | September 2015 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Abdominal
- Participants undergoing surgeries with an abdominal approach will be given a Morphine PCA at a dose of 2mg every 10 minutes with a 12mg/hour lockout. They will also be given IV Toradol at 30mg every 6 hours as needed for a maximum of four doses.
|
|
Vaginal
- Participants undergoing surgeries with a vaginal approach will be given hydrocodone/acetaminophen at a dose of 5/325 (1-2 tablets every four hours as needed), and provided with Ibuprofen 800mg every 8 hours as needed.
|
Detailed Description:
Objectives: The purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population.
Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).
Inclusion Criteria:
- Age at least 21
- Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center
Exclusion Criteria:
- Age < 21
- Inability to complete the written questionnaires
- Undergoing concurrent procedures for condition other than pelvic organ prolapse
Contacts and Locations| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center | |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: | Abbas Shobeiri, MD | University of Oklahoma |
More Information
No publications provided
| Responsible Party: | University of Oklahoma |
| ClinicalTrials.gov Identifier: | NCT01530191 History of Changes |
| Other Study ID Numbers: | shobeiridepression_10.18.11 |
| Study First Received: | January 19, 2012 |
| Last Updated: | February 6, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Oklahoma:
|
depression anxiety pelvic organ prolapse POP |
Additional relevant MeSH terms:
|
Anxiety Disorders Depression Depressive Disorder Prolapse Pelvic Organ Prolapse |
Mental Disorders Behavioral Symptoms Mood Disorders Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 19, 2013