Pain Reduction by Forced Coughing During Colposcopy Guided Cervical Biopsies: a Randomized Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Difference in pain between first and second biopsy
研究概览
简要总结
To investigate the effect of coughing as an intervention to reduce pain in colposcopy guided biopsy.
详细描述
Colposcopy is a frequently practiced examination and Colposcopy guided biopsy causes pain. A few trials Investigated whether medical interventions such as the application of lidocaine led to reduced pain perception with inconsistent results. Only one trial compared coughing versus no coughing at the moment of biopsy. Although the results of this study did not lead to a significant difference between the two study arms, coughing seems to positively affect pain perception.
Since the patients are, in the best case, their own controls when it comes to subjective parameters such as pain perception, we prefer a cross-over rather than a parallel group design.
Based on the descriptive variables for pain during biopsy with and without cough determined in the pilot study, a case estimate for a prospective randomized cross-over study will be carried out. Since two biopsies are usually taken from the cervix in daily practice, the now planned pilot study in a cross-over design envisages the following two study arms:
- Group I: Patients cough during the first biopsy, they do not cough during the second biopsy
- Group II: Patients cough during the second biopsy, they do not cough during the first biopsy
The primary Outcome measure is the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS).
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Completed 18 years of age
- •written informed consent
- •first colposcopy
- •Clinically indicated colposcopy in case of an abnormal PAP smear or screening result and/or clinical abnormalities on the cervix uteri
- •Necessity to take exactly two biopsies
排除标准
- •Performing only one biopsy or more than two biopsies
- •Performing an endocervical curettage (biopsy on the endocervix)
- •Vaginal bleeding at the time of examination
- •inadequate colposcopy
- •Cervix uteri cannot be fully visualized
- •Pregnancy
- •Patients with insufficient German language skills
- •known anxiety disorders or depressive disorders
- •Treatments already carried out on the cervix uteri
- •Patients with a chronic or acute illness that influences the perception of pain or lead to permanent pain due to the disease itself
- •psychosomatic illnesses
- •Chronic use of pain medications or psychotropic medications or other medications that may have an influence on the sensation of pain
结局指标
主要结局
Difference in pain between first and second biopsy
时间窗: Immediately after the examination
the difference in the patients' perception of pain during the first and second biopsy on the cervix (ectocervix), measured using an 11-part numerical analogue scale (11-item NAS). The numerical analogue scale consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' (score 0) and 'pain as bad as it could be' (score 10). Women will be asked to mark her pain level on the line between the two endpoints.
次要结局
- Pain perception when inserting the specula(Immediately after the insertion of the specula)
- Pain perception when using acetic acid(Immediately after the application of acetic acid)
- Pain perception at second biopsy(Immediately after the second biopsy was performed)
- Pain perception before examination(Immediately before the start of the examination)
- Pain perception just after examination(Immediately after the removal of the specula)
- Pain perception at first biopsy(Immediately after the first biopsy was performed)
研究者
Dr. med. Ziad Hilal
Principal Investigator
Zydolab - Institute of Cytology and Immune Cytochemistry