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临床试验/NCT07585240
NCT07585240尚未招募不适用

Effect of Warm Foot Bath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery: A Randomized Controlled Trial

Igdir University0 个研究点目标入组 60 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
60

研究概览

简要总结

Chest tube removal is a widely used surgical procedure, particularly in the post-cardiac surgery period, to maintain cardiopulmonary stability, provide mediastinal drainage, and prevent potential complications. It provides one-way drainage of air and/or fluid accumulated in the pleural space through closed drainage systems. Chest tube removal is often described by patients as a painful and frightening experience. Without adequate pain control, chest tube removal can cause severe pain and anxiety in patients, limiting their physical activity and negatively impacting coughing and deep breathing. Consequently, this can lead to inadequate expansion of the thoracic cavity and predisposition to respiratory tract infections.

Pain management is considered a fundamental component of nursing care. Effective pain management relies on comprehensive assessment, application of appropriate pharmacological and non-pharmacological interventions, and monitoring of patient response. Pharmacological agents commonly used during chest tube removal include local anesthetics, opioid analgesics, and anti-inflammatory drugs. However, pharmacological methods can have side effects such as vomiting, nausea, respiratory distress, and hypotension, which can reduce patient comfort. Therefore, given the frequent use and potential side effects of pharmacological methods, there is an increasing need for non-pharmacological methods that are safe, easy to apply, and have no side effects in pain and anxiety management. The literature reports that non-pharmacological interventions are effective in reducing pain felt during chest tube removal. Studies in the literature show that relaxation exercises, a non-pharmacological method, are cost-effective, easy to apply, and effective in reducing pain and anxiety levels. These exercises have been shown to provide physiological relaxation by supporting muscle activation and are effective in pain management in patients after surgical procedures. Another non-pharmacological method used to reduce postoperative pain and anxiety is warm foot baths. Warm foot baths are reported to increase peripheral temperature, causing vasodilation, supporting autonomic balance, and providing physiological relaxation. While studies evaluating the effects of warm foot baths on pain and anxiety in various clinical situations exist in the literature, no study examining its effect during chest tube removal has been found. This indicates a significant knowledge gap in the literature regarding the potential effects of warm foot baths during chest tube removal. Accordingly, this research was planned to determine the effects of relaxation exercises applied before chest tube removal and warm foot baths applied simultaneously with relaxation exercises on pain and anxiety levels in patients undergoing cardiac surgery. The research will be conducted using a two-arm, parallel-group, randomized comparative experimental design. Considering the effect sizes reported in the literature for similar interventions and accounting for both literature-based and repeated-measures calculations, a median effect size was assumed. Accordingly, the study targeted a sample size of 30 patients per group (total n=60). The relaxation group (R) and the warm water footbath group (WWF+R) will be assigned using a block-randomized design. The R group will receive guided breathing and progressive muscle relaxation exercises. The WBB+R group will receive guided breathing and progressive muscle relaxation exercises, along with a warm-water foot bath. The interventions will begin with a pre-application to familiarize patients with the procedures. In the second phase, patients will perform the procedures 15 minutes before the scheduled chest tube removal time. Data will be collected at four time points using the Visual Analog Scale and the State Anxiety Scale. Appropriate statistical methods will be used for data analysis. This research has the potential to be the first randomized comparative study examining the simultaneous effects of a warm-water foot bath and relaxation exercises during chest tube removal after cardiac surgery. The findings are expected to contribute a new, low-cost, non-invasive, and evidence-based intervention to post-surgical nursing care protocols. The research outcomes are expected to improve patient comfort and the quality of clinical care.

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
Double (Participant, Outcomes Assessor)

盲法说明

Due to the nature of the interventions, participants and the researcher cannot be blinded; however, the data analyst will be blinded to the group assignments.

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

  • Aged 18 years and older
  • Followed up with at least one chest tube after elective cardiac surgery -Scheduled for chest tube removal
  • Conscious, with a Glasgow Coma Scale (GCS) score of 15
  • Hemodynamically stable (Mean Arterial Pressure [MAP] ≥ 65 mmHg, and Peripheral Oxygen Saturation [SpO₂] ≥ 92% on room air or with routine oxygen support)
  • No visual or auditory impairments
  • Able to speAk and understand Turkish
  • No clinically diagnosed neurological or psychiatric disease, and not using regular psychotropic medications

排除标准

  • Aged under 18 years
  • Presence of diabetic peripheral neuropathy, peripheral vascular disease, or conditions disrupting foot/skin integrity (conditions where a warm water foot bath is contraindicated)
  • Hemodynamically unstable (Mean Arterial Pressure [MAP] < 65 mmHg)
  • Presence of severe cognitive impairment, psychotic disorder, or hallucinations
  • Administered any analgesic medication outside the current analgesia protocol within the last 24 hours
  • Glasgow Coma Scale (GCS) score below 15
  • Inability to speak Turkish or presence of any condition preventing communication

研究者

发起方
Igdir University
申办方类型
Other
责任方
Principal Investigator
主要研究者

özlem ABI

Research Assistant

Igdir University

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