Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06416982
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-05-13
Brief Title:
Perineal Massage for Pessary Examinations
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Perineal Massage for Increased Comfort During Pessary Examinations a Cross-over Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-05
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:
Pessaries are effective non-surgical devices for reduction of prolapse However use of pessaries are limited in some women due to patient discomfort While lidocaine can be used to improve pessary checks its use may be limited due to supply chain shortages lack of insurance coverage and optimization of resource utilization More techniques to improve pessary examination comfort are needed Perineal massage prior to delivery and at the time of active labor has been noted to reduce perineal trauma and perineal discomfort theoretically by desensitizing the nerve endings in the skin broadening the vaginal opening and increasing elasticity of the perineal tissue Since most discomfort with pessary checks is during removal and insertion through the vaginal introitus perineal massage may be a beneficial technique that women could potentially learn to improve comfort with pessary checks
The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial
Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study The study will involve two clinical visits At the first visit the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule as well as internal massage with the thumb gliding from 4 to 8 oclock then tissue stretching technique with one intracavitary finger and other external finger at the 4 oclock and 8 oclock positions three times versus application of gel to the internal vagina and external vagina without massage Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols
Patients will rate self-reported pain before during pessary check and after the pessary check on a VAS scale and rate whether they would prefer to repeat this method at future visits via Likert scale Healthcare professionals will also rate perceived patient pain on VAS scale ease of pessary removal and note any perineal or introital laceration or abrasion that may occur during the pessary fitting
At the following visit patients will be assigned to the group to which they were not initially randomized Patients and healthcare professionals will again rate pain as described above Patients will also rank preference for perineal massage using PGI-I
The objective of this study is to examine the effectiveness of perineal massage prior to pessary check in improving comfort of pessary checks for patients using a cross-over randomized controlled trial
Patients who follow up for pessary checks with the division of Urogynecology at UNC will be approached about participating in this study The study will involve two clinical visits At the first visit the patient will be randomized to 2 minutes of perineal massage with water based gel of the external perineum and sides of the vaginal vestibule as well as internal massage with the thumb gliding from 4 to 8 oclock then tissue stretching technique with one intracavitary finger and other external finger at the 4 oclock and 8 oclock positions three times versus application of gel to the internal vagina and external vagina without massage Providers will be blinded to randomization and proceed with pessary check as per normal clinical protocols
Patients will rate self-reported pain before during pessary check and after the pessary check on a VAS scale and rate whether they would prefer to repeat this method at future visits via Likert scale Healthcare professionals will also rate perceived patient pain on VAS scale ease of pessary removal and note any perineal or introital laceration or abrasion that may occur during the pessary fitting
At the following visit patients will be assigned to the group to which they were not initially randomized Patients and healthcare professionals will again rate pain as described above Patients will also rank preference for perineal massage using PGI-I
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None