Perineal Massage for Increased Comfort During Pessary Examinations: a Cross-over Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Patient-perceived pain
研究概览
简要总结
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 o'clock, then tissue stretching technique with one intracavitary finger and other external finger at the 4 o'clock and 8 o'clock 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Investigator)
盲法说明
Participants will be randomized to intervention vs no intervention at the first visit without stratification, then will undergo the opposite intervention at the second visit. While participants cannot be blinded to the intervention, providers performing the pessary checks and providing provider-perceived pain scores will be blinded to the intervention as someone on the research team other than the provider will perform the intervention prior to the pessary check. If there is unexpected breaking of the blind (e.g. participant tells provider which intervention was performed), the provider will report this to the research team and this will be noted in the study results.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Undergoing routine pessary management by office providers
- •Able to provide informed consent (as reported by patient or family member)
- •Able to follow up with the UNC Urogynecology office for two consecutive pessary examination
排除标准
- •Non-English speaking
- •Found to have a condition such as significant vaginal erosion that precludes replacement of pessary after exam
- •Unable to undergo massage due to functional or cognitive impediments or significant discomfort during massage
- •Regular usage of pain medications for prior pessary checks such as lidocaine, and unwilling to forgo lidocaine for two study visits
- •Pessary visit for pain, pessary expulsion, or significant bleeding, as per provider's judgement
结局指标
主要结局
Patient-perceived pain
时间窗: 3 months
Change in pain scores during pessary check (removal and replacement) compared to baseline pain score prior to pessary check using a visual analog scale (VAS) pain scale, as reported by the participant. The VAS pain scale is a validated scale that is performed by having the participant place a mark on a 10 cm line from 0 to 10 to indicate severity of pain. 0 indicates no pain, 10 indicates the most severe pain. Distance from 0 to the mark is measured and recorded in millimeters.
次要结局
- Perineal and vaginal abrasion(3 months)
- Provider-perceived patient discomfort(3 months)
- Provider-perceived ease of pessary removal(3 months)
- Patient preference for future perineal massage(3 months)
- Patient satisfaction with perineal massage(3 months)