Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery

Official title

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

Overview

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.

Interventions

• Behavioral Relaxation Exercises
  Administered exactly 15 minutes prior to chest tube removal. The structured session lasts a total of 15 minutes and consists of two sequential components: 5 minutes of guided breathing (inhaling for 4 seconds, holding for 4 seconds, and exhaling for 6 seconds), immediately followed by 10 minutes of progressive muscle relaxation. The muscle relaxation involves systematically tensing muscle groups for 5 seconds and relaxing them for 10 seconds, progressing from the toes up to the head.
• Other Warm Water Foot Bath
  Administered exactly 15 minutes prior to chest tube removal. The patient sits on the edge of the bed and immerses their feet up to the ankles in a basin containing 10-15 liters of water heated to exactly 40°C. This physical intervention is conducted concurrently with guided relaxation exercises to combine peripheral physical relaxation with central psychological relaxation.

Primary outcome measures

• Pain Intensity Assessed by Visual Analog Scale (VAS) [Time frame: Assessed at four time points: pre-intervention, immediately post-intervention (pre-removal), immediately post-chest tube removal, and 15 minutes post-removal.]
• Anxiety Level Assessed by State Anxiety Inventory (STAI-S) [Time frame: Assessed at two time points: pre-intervention and 15 minutes post-chest tube removal.]
• Anxiety Level Assessed by Visual Analog Scale (VAS) [Time frame: Assessed at two time points: immediately post-intervention (pre-chest tube removal) and immediately post-chest tube removal.]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Uslu Y, Akbayrak H, Kuytak Ortahisar B, Barak TH. The effect of lavender foot baths on postoperative pain and sleep quality in comparison with foot baths with warm water only-A prospective randomized controlled study. Explore (NY). 2024 May-Jun;20(3):385-391. doi: 10.1016/j.explore.2023.10.003. Epub 2023 Oct 5. PMID 37863680
• Tsai CS, Tung HH, Fang CJ, Chen CT. Effectiveness of non-pharmacological interventions for pain reduction following chest tube removal: A systematic review and network meta-analysis. Intensive Crit Care Nurs. 2025 Apr;87:103909. doi: 10.1016/j.iccn.2024.103909. Epub 2024 Nov 29. PMID 39615184

Identifiers

NCT: NCT07585240 · E-37077861-900-197647

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗