The Effect of Progressive Relaxation Exercises and Transcutaneous Electrical Nerve Stimulation Administered to Women Delivering Via Cesarean Section on Acute Pain, Breastfeeding Behaviors, and Comfort Levels: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Change in acute pain
研究概览
简要总结
This study aimed to determine the effect of progressive relaxation exercises and transcutaneous electrical nerve stimulation administered to women delivering via cesarean section on acute pain, breastfeeding behavior, and comfort levels. Single-Blind, Randomized Controlled Study. This study was carried out in the obstetrics and gynecology clinic of a university hospital affiliated with the Ministry of Health in Turkey between August 20, 2018 and April 15, 2019. A total of 120 participants were randomly assigned to one of four groups, which included a transcutaneous electrical neural stimulation (TENS) group, a progressive relaxation exercises (PRE) group, a combined intervention (TENS+PRE) group, and a control group. Data were collected with a data collection form, the visual analogue scale (VAS), the LATCH breastfeeding diagnostic tool (LATCH), and the postpartum comfort scale (PCS). In the analysis of the data, numbers, percentages, and chi-square tests were used. Also, median values, Wilcoxon Signed-rank test, and Kruskal-Wallis H test were employed for continuous variables.
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
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
- •women who were aged between 18 and 45,
- •who were in the postoperative 8th hour,
- •who had a transverse cesarean section,
- •who, as well as their babies, did not develop any complications during pregnancy, delivery, and the postpartum period.
排除标准
- •women who did not have an open wound on their body and/or allergic disease on their skin,
- •who had cardiac arrhythmia or a pacemaker,
- •who had a risk of epilepsy,
- •who had epilepsy, eclampsia, kidney or liver disease,
- •who had previously applied TENS and PRE methods,
- •who were morbidly obese (with a BMI value of over 40),
- •who used chronic opioids, antidepressants, and psychoactive drugs.
结局指标
主要结局
Change in acute pain
时间窗: VAS was applied in the first eighth hour during the postoperative 48 hours, before and after each application in the intervention groups, and in the control group at the times corresponding to the applications in the intervention groups.
The Visual Analog Scale (VAS) was used in the evaluation of acute pain.
次要结局
- Change in breastfeeding behavior(LATCH was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.)
- Change in comfort level(Postpartum Comfort Scale was applied in the first eighth hour (before the first application) during the postoperative 48 hours. It was applied again on the first and second days when all interventions were completed.)
研究者
Derya Öztürk Özen
Principal Investigator
Bozok University