The Effect of Acupressure After Cesarean Section on Pain Intensity and First Mobilization Distance: A Double-Blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Pain evaluated using the visual analog scale
研究概览
简要总结
This randomized controlled trial evaluates the effect of acupressure application on cesareans' pain and the number of steps in the first mobilization. This study hypothesizes that acupressure reduces pain and improves number of steps.
详细描述
Methods: In the study, 64 cesareans will randomly assigned to acupressure and placebo acupressure groups. To the acupressure group (n = 32), an average of 15 minutes will be applied to the LI4 (liver), P6 (pericardium) and the Sanyinjia points on the splenic meridian (SP6) located on the inner side of the lower leg, four fingers above the ankle and behind the tibia. In the placebo acupressure group (n = 32), the points 1.5 cm away from the LI4, P6 and SP6 points (four points in total) will be applied for an average of 15 minutes. The primary outcome of the research is the effect of acupressure on the pain of cesareans. The secondary outcome of the study is to determine the effect of acupressure on the number of steps. The pain will be collected before and 1 minute, 2nd and 4th hour after acupressure and placebo acupressure administration. The number of steps will be collected 4th hour after acupressure and placebo acupressure administration.
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
- None
盲法说明
In the study, a researcher (T.Ç.Y.) will determine the acupressure and placebo points to be applied to women. However, the researcher (A.A.) 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. Thus, the research will be carried out as a double-blind randomized controlled trial. 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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Being conscious,
- •The mother tongue is Turkish,
- •To be oriented and cooperative,
- •be between 18-45 years old,
- •To voluntarily agree to participate in the study (signing the Informed Consent Form),
- •Repeated cesarean section,
- •Cesarean section under spinal anesthesia,
- •Not having a risky pregnancy (preeclampsia, gestational diabetes etc.),
- •No health problems of the fetus,
- •To have given birth by cesarean section between 37-40 weeks,
- •To be in the second hour of the postpartum period,
- •Not receiving post-op patient-controlled analgesia,
- •Not to have smoked or used alcohol during pregnancy,
- •No complications in the mother and/or newborn after cesarean section,
- •No sensitivity in the area where acupressure will be applied,
- •Absence of any systemic or psychiatric diagnosis,
- •Absence of active COVID-19 infection.
排除标准
- •Lack of consciousness,
- •The mother tongue is not Turkish,
- •Not oriented and cooperative,
- •Not to be between the ages of 18-45,
- •Refusal to voluntarily participate in the study (those who did not sign the Informed Consent Form),
- •Normal birth or cesarean delivery under general anesthesia,
- •Cesarean delivery due to the risk of deterioration of maternal or fetal health,
- •Not having had a risky pregnancy (preeclampsia, gestational diabetes, etc.),
- •Not giving birth outside 37-40 weeks and by cesarean section,
- •Not in the second hour of the postpartum period,
- •Receiving post-op patient-controlled analgesia,
- •To have used cigarettes and alcohol during pregnancy,
- •Sensitivity in the area where acupressure will be applied,
- •Presence of any systemic or psychiatric diagnosis,
- •Active COVID-19 infection.
结局指标
主要结局
Pain evaluated using the visual analog scale
时间窗: Change from before implementation and after 1 minute, 2nd and 4th hour after implementation
The total scale score is in the range of 0 cm (minimum) -10 cm (maximum). A score of 0 indicates no pain and a score of 10 indicates very severe pain.
次要结局
- The number of steps using step counter (TNV 3D Pedometer (Model: PM2000, Made in China)(Change 4th hour after acupressure)
研究者
Tugba CAM YANIK
Research Assistant
Mersin University