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

NCT07585240 | Not Yet Recruiting

• 1 other identifier: E-37077861-900-197647
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chest Tube Removal

Keywords

chest tube removal; warm foot bath; anxiety; pain

Outcome Measures

Primary Outcomes (3)

• Pain Intensity Assessed by Visual Analog Scale (VAS)

  Pain intensity will be evaluated using a 10-cm Visual Analog Scale (VAS). The scale consists of a 10-cm line ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "unbearable pain". Participants mark their pain level on the line, and higher scores represent a greater intensity of pain.

  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)

  Anxiety will be measured using the 20-item State Anxiety Inventory (STAI-S). The STAI-S is scored on a 4-point Likert scale (1=not at all, 4=very much so), with total scores ranging from 20 to 80. Higher scores indicate greater anxiety levels.

  Assessed at two time points: pre-intervention and 15 minutes post-chest tube removal.

• Anxiety Level Assessed by Visual Analog Scale (VAS)

  Anxiety will be evaluated using a 10-cm Visual Analog Scale (VAS) for anxiety. The scale ranges from 0, indicating "no anxiety," to 10, indicating "highest anxiety". Participants mark their anxiety level on the line, and higher scores represent a greater level of anxiety.

  Assessed at two time points: immediately post-intervention (pre-chest tube removal) and immediately post-chest tube removal.

Study Arms (2)

Warm Water Foot Bath and Relaxation (WFB+R) Group

EXPERIMENTAL

Patients assigned to this arm will immerse their feet in a basin filled with 40°C warm water while simultaneously performing relaxation exercises. The relaxation exercises consist of 5 minutes of guided breathing and 10 minutes of progressive muscle relaxation. This combined intervention begins exactly 15 minutes prior to the chest tube removal procedure.

Behavioral: Relaxation Exercises; Other: Warm Water Foot Bath

Relaxation (R) Group)

ACTIVE COMPARATOR

Patients assigned to this arm will perform only the relaxation exercises, which consist of 5 minutes of guided breathing and 10 minutes of progressive muscle relaxation. This intervention begins exactly 15 minutes prior to the chest tube removal procedure.

Behavioral: Relaxation Exercises

Interventions

Relaxation Exercises BEHAVIORAL

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.

Relaxation (R) Group); Warm Water Foot Bath and Relaxation (WFB+R) Group

Warm Water Foot Bath OTHER

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.

Warm Water Foot Bath and Relaxation (WFB+R) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Igdir University: lead
• Koç University: collaborator

Related Publications (2)

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Mental Disorders; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Özlem abı, Nurse

CONTACT

+905538840573; ozlemabi89@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: This study is a randomized, controlled, parallel-group trial designed to evaluate the effects of relaxation exercises (R) versus a combination of relaxation exercises and warm water foot bath (R+WFB) on pain and anxiety levels in adult patients undergoing chest tube removal after cardiac surgery.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 13, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: May 13, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available beginning 6 months and ending 36 months following article publication.
• Access Criteria: Data will be shared with researchers who provide a methodologically sound proposal for secondary analyses or meta-analyses. Proposals should be directed to the corresponding author. To gain access, data requestors will need to sign a data access agreement