Ameliorating the Obstacle of Pap Smear: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Recalled pain just after the Pap smear test using a 1-5 numeric scale
研究概览
简要总结
To reduce the procedural pain of Pap smear, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. This study aims to conduct a randomized controlled study at a tertiary center, National Taiwan University Hospital (NTUH). The investigators expect to compare the recalled pain intensity of the intervention and control groups.
详细描述
Purpose: In order to reduce the procedural pain, this study expects to apply the peak-end rule to Pap smear by prolonging the insertion of speculum after samples are obtained from the cervix. Methods: This study aims to conduct a randomized controlled study at NTUH. Approximately 200 subjects are expected to be recruited. The investigators will utilize the peak-end rule by adding a non-painful step right after the most uncomfortable phase in the intervention group. All study subjects are requested to score on a numeric pain scale during the Pap test. All operators experienced in techniques for performing a Pap test should attend workshops for a standard operating procedure. A well-trained research assistant is also responsible for ensuring standardization of procedures to eliminate interoperator variability. The primary outcome was the recalled pain intensity at five minutes after the Pap smear test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
During the Pap test, there is a privacy curtain separating participants from the operators. Participants receiving the modified Pap test do not realize what is going on during the 15-second step because they are behind the privacy curtain. The operators performing the procedure are not informed whether to intervene or not by the assistants until a specimen is prepared for cervical cytology. The delayed disclosure of the group allocation until this step ensures the operators standardizing the insertion and opening phases of the Pap test.
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Biological female
- •Aged 30-70
- •Provision of written informed consent
排除标准
- •Pregnancy
- •Active vaginal or uterus infection
- •Incapable of understanding the numeric pain scales
- •Prior cervical cancer diagnosis
- •Prior hysterectomy, pelvic or vaginal surgery
- •Ongoing menstruation
- •Use of painkillers within 24 hours
结局指标
主要结局
Recalled pain just after the Pap smear test using a 1-5 numeric scale
时间窗: Five minutes after the Pap test
This recalled pain intensity is evaluated with a 1-5 numeric scale (1:no pain; 5: maximal pain).
Recalled pain just after the Pap smear test using a a 0-10 visual analog scale
时间窗: Five minutes after the Pap test
This recalled pain intensity is evaluated with a 0-10 visual analog scale (0: no pain; 10: maximal pain), where pain was categorized as mild, moderate, and severe.
次要结局
- Long-term recalled pain after the Pap test using a 0-10 visual analog scale(One year after the Pap test)
- Long-term recalled pain after the Pap test using a 1-5 numeric scale(One year after the Pap test)
- Real-time pain during the Pap test using a 1-5 numeric scale(Every five seconds throughout the Pap test)
- Willingness to receive further Pap tests(One year after the Pap test)