Effect of Acupressure Applied Before Cystectomy on Preoperative Anxiety Level: Three Blind Randomized Controlled Studies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Anxiety evaluated using the State Anxiety Scale
研究概览
简要总结
This randomized controlled study evaluates the effect of acupressure application on the anxiety level patients undergoing cystectomy surgery. The hypothesis of this study is that acupressure reduces anxiety levels and stabilizes hemodynamic parameters.
详细描述
In the study, 60 patients will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 30), an average of 15 minutes will be applied to the HT7 (heart), LI4 (liver) and EX-NH3 (the point between the two eyes). In the placebo acupressure group (n = 30), the points 1.5 cm away from the HT7, LI4, and EX-NH3 points will be applied for an average of 15 minutes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to patients. However, the researcher (Z.Y.) who will apply acupressure and placebo acupressure be blinded without knowing whether these points are acupressure or placebo points. Participants will not know that they are in the acupressure or placebo group. When the research is completed, the data of the control and study groups (A or B) will be transferred to the computer environment by a researcher independent of the research, and the data will be analyzed by a statistician and the findings will be reported.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Agreeing to participate in the research (signing the Informed Consent Form),
- •Conscious and cooperative
- •Speaks and understands Turkish,
- •18-65 years old,
- •Before surgery,
- •Stable general condition,
- •No sensitivity in the area where acupressure/placebo acupressure will be applied,
- •15 July 2022 - 15 July 2023 hospitalized in the urology clinic,
- •No active COVID-19 infection,
- •Patients without any psychiatric diagnosis will be included.
排除标准
- •Those who do not agree to participate in the research (who do not sign the Informed Consent Form)
- •Conscious and uncooperative,
- •Not speaking or understanding Turkish,
- •Not between the ages of 18-65,
- •No surgical intervention planned,
- •The planned emergency surgical intervention,
- •Unstable general condition,
- •Sensitivity in the area where acupressure/placebo acupressure will be applied,
- •Active COVID-19 infection,
- •15 July 2022 - 15 July 2023 who did not stay in the urology clinic,
- •Patients with current psychiatric diagnosis will not be included in the study.
结局指标
主要结局
Anxiety evaluated using the State Anxiety Scale
时间窗: Change from before implementation and immediately after, 20th minute after acupressure
Scores ranging from 20 to 80 points are obtained in the scale. In the total score obtained from the scale in scoring the scale, 0-19 points indicate the absence of anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety level. Higher state anxiety scores indicate that anxiety level is also high
次要结局
- Respiratory rate(Change from before implementation and immediately after, 20th minute after acupressure)
- Systolic blood pressure(Change from before implementation and immediately after, 20th minute after acupressure)
- Diastolic blood pressure(Change from before implementation and immediately after, 20th minute after acupressure)
- Heart rate(Change from before implementation and immediately after, 20th minute after acupressure)
- Peripheral oxygen saturation(Change from before implementation and immediately after, 20th minute after acupressure)
研究者
Tugba CAM YANIK
PhD Research Assistant
Mersin University