Chest Tube RemovalNCT07585240
Effect of Warm Footbath Combined With Relaxation Exercise on Pain and Anxiety During Chest Tube Removal After Cardiac Surgery
A study testing Relaxation Exercises and Warm Water Foot Bath in people with Chest Tube Removal, run by Igdir University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chest Tube Removal
- What is being tested?
- Relaxation Exercises and Warm Water Foot Bath
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2027to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Relaxation Exercises, Warm Water Foot Bath
- Keywords
- chest tube removal, warm foot bath, anxiety, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation ExercisesBehavioural
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.
Warm Water Foot BathOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Relaxation Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Assessed at two time points: immediately post-intervention (pre-chest tube removal) and immediately post-chest tube removal.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2026
- Study start1 Jan 2027 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chest Tube RemovalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Igdir University
- Sponsor type
- University, hospital or other
- Collaborators
- Koç University
- Responsible party
- Principal investigator, özlem ABI, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07585240
- Sponsor's protocol ID
- E-37077861-900-197647
- Status last verified
- Aug 2026
- First submitted
- 5 May 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in the publication will be available for sharing.
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.
PubMed 37863680Tsai 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.
PubMed 39615184
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07585240
- Acronym / sponsor ID
- E-37077861-900-197647
- Conditions
- Chest Tube Removal
- Keywords
- chest tube removal, warm foot bath, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Igdir UniversityUniversity, hospital or other
- Collaborators
- Koç University
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 13 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Warm Water Foot Bath and Relaxation (WFB+R) Group | Experimental | Behavioral: Relaxation Exercises, Other: Warm Water Foot BathPatients 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. |
| Relaxation (R) Group) | Active comparator | Behavioral: Relaxation ExercisesPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Relaxation ExercisesAdministered 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. | Behavioural | Relaxation (R) Group), Warm Water Foot Bath and Relaxation (WFB+R) Group |
| Warm Water Foot BathAdministered 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. | Other | Warm Water Foot Bath and Relaxation (WFB+R) Group |
Primary outcome
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.
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.
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 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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 37863680Uslu 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.
- Background: PubMed 39615184Tsai 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.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in the publication will be available for sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Relaxation Exercises and Warm Water Foot Bath in people with Chest Tube Removal, run by Igdir University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Özlem abı, Nurse (+905538840573, ozlemabi89@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07585240, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.