Improving Patient Experience in Gynecologic Examinations With a Stress Ball: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Pain intensity during Pap smear procedure
研究概览
简要总结
Women's anxiety about gynecological examinations causes them to skip examinations during this process. Research shows that women with high levels of anxiety are more likely to feel pain. Women who can manage their anxiety can increase their satisfaction by reducing pain levels during the examination . The stress ball has the potential to improve the patient experience by reducing these anxieties. This will positively affect women's willingness to participate in gynecological examinations and follow-up processes.
详细描述
Secondary outcomes (anxiety and patient satisfaction) were pre-specified in the ethics committee-approved study protocol and were collected as planned. These outcomes were inadvertently omitted from the initial trial registry entry and have now been added to accurately reflect the original protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being between the ages of 18-35,
- •Being literate, knowing and understanding Turkish,
- •Don't have a pap-smear test for the first time,
排除标准
- •Presence of chronic pain in the pelvic region,
- •Presence of a condition in the wrists that prevents squeezing the stress ball,
- •Congenital malformation of the cervix, .Having a known diagnosis of a serious psychiatric illness.
研究组 & 干预措施
Stress Ball
After the initial measurements of the participants assigned to the experimental group, the students involved in the project will accompany the patient and prepare the patient for the gynecological examination. To make the patient feel more comfortable during the gynecological examination, she will be given two stress balls. The patient will be asked to count each time she squeezes the stress ball during the examination. During the gynecological procedure, the participant will be administered the first EC-3. The stress ball intervention will help to reduce the participant's anxiety level and make the examination process more tolerable.
干预措施: Stress Ball (Behavioral)
Control
After the initial measurements of the participants assigned to the control group, the student involved in the project will prepare the patient for a gynecological examination. Patients in the control group will be provided with only a relaxing environment, without a stress ball during the examination.
结局指标
主要结局
Pain intensity during Pap smear procedure
时间窗: Immediately after the Pap smear procedure
Pain assessed using a Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).
次要结局
- Change in State Anxiety Level(Immediately after the Pap smear procedure)
- Patient Satisfaction with the Gynecological Examination(Immediately after the Pap smear procedure)
研究者
Betul Uncu
Principal Investigator
Istanbul University - Cerrahpasa