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临床试验/NCT06177873
NCT06177873已完成不适用

Effect of Foot Bath on Pain, Anxiety, Sleep and Comfort Level: Randomized Control

Dilek GÜRÇAYIR2 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2022年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
108
试验地点
2
主要终点
Visual Analog Comfort scale

研究概览

简要总结

This study was planned and will conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.

Research hypotheses H1: A hot foot bath reduces postoperative pain in patients undergoing laparoscopic cholecystectomy.

H2: A hot foot bath reduces postoperative anxiety in patients undergoing laparoscopic cholecystectomy.

H3: A hot foot bath improves postoperative sleep in patients undergoing laparoscopic cholecystectomy.

H4: A hot foot bath improves postoperative comfort in patients undergoing laparoscopic cholecystectomy.

详细描述

Nurses play an important role in patients; pain management during the peroperative period. In this process, non-steroidal anti-inflammatory drugs, opioids, patient-controlled analgesia and local anesthetics can be used pharmacologically in pain management. However, it has been reported in the literature that using pharmacological and non-pharmacological applications together in pain management has better positive effects on the patient. Hot application, cold application, transcutaneous electrical nerve stimulation, massage, reiki, music therapy, aromatherapy are some of the non-pharmacological applications used to relieve pain in the postoperative period.

Hot application is one of the effective, cheap and easy-to-use non-pharmacological methods in relieving pain. Hot applications can be made as dry hot, local wet and general wet applications. Foot bath with hot water is one of the non-pharmacological methods that nurses can apply to relieve post-operative patients; pain, reduce anxiety and stress levels, relax muscles and improve sleep quality. There are studies in the literature showing that heat application reduces pain levels and improves sleep quality in different patient groups. In the study of Aghamohammadi et al., it was found that a 20-minute hot foot bath applied to women in menopause improved sleep quality. In the study of Han et al., it was found that hot foot bath with aromatherapy applied to patients with edema in the lower extremities significantly reduced pain and edema. In the study of Soonyoung and Myoungjin, it was determined that hot water foot bath applied to patients who underwent hand replantation reduced the pain of the patients. In another study, hand and foot baths after cesarean section were effective in reducing the pain of patients. When the literature was examined, no study was found examining the effect of hot foot bath on anxiety, pain, sleep and comfort levels after laparoscopic cholecystectomy. In this context, this study was planned and conducted to determine the effect of hot foot bath on pain, anxiety, sleep and comfort levels in patients undergoing laparoscopic cholecystectomy.

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 (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 years of age or older
  • Patients did not have any psychological disorders, cancer, hypertension or heart disease and did not use any medication related to these diseases
  • Patients used the same type of analgesic for pain control in the postoperative period,
  • Patients had a VAS pain level of 4 or above, had no foot pain
  • Patients who did not have wounds, infections or infectious diseases
  • Patients who did not develop any complications before, during and after surgery were

排除标准

  • Patients who developed any complications before, during or after surgery
  • Patients who had drains were not included in the study.

结局指标

主要结局

Visual Analog Comfort scale

时间窗: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

Zero is equivalent to no comfort and 10 indicates the worst possible comfort.

Visual Analog Sleep Scale

时间窗: On the surgery morning, first day after surgery.

Zero is equivalent to the best sleep and 1000 indicates the worst possible sleep.

Visual Analog pain scale

时间窗: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

Zero is equivalent to no pain and 10 indicates the worst possible pain.

The State-Trait Anxiety Inventory Form (STAI)

时间窗: 4 hours after the surgery, after the application at the 5th, 30th, 60th and 120th minutes.

20 is equivalent to no anxiety and 80 indicates the worst possible anxiety.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Dilek GÜRÇAYIR

Assistant professor

Ataturk University

研究点 (2)

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