An interventional study of Box breathing in Open-Heart Surgery, sponsored by Mersin University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Mersin University · Not applicable, Interventional, and Supportive care
This randomized controlled trial aims to evaluate the effects of box breathing performed before chest tube removal on pain, anxiety, dyspnea, and hemodynamic parameters in patients undergoing open-heart surgery. A total of 86 patients will be randomly assigned in a 1:1 ratio to either the box breathing group or the control group. Participants in the intervention group will perform the 4-4-4-4 box breathing technique for approximately five minutes before chest tube removal in addition to routine care, while participants in the control group will receive routine care only. Pain, anxiety, dyspnea, and hemodynamic parameters will be assessed before and at specified time points after chest tube removal.
Chest tube removal is a routine procedure following open-heart surgery; however, it may cause pain, anxiety, dyspnea, and changes in hemodynamic parameters. Nonpharmacological interventions that are simple, safe, and easy to apply may contribute to symptom management during this procedure.
This prospective, two-arm, parallel-group randomized controlled trial will evaluate the effects of box breathing performed before chest tube removal in patients undergoing open-heart surgery. A total of 86 eligible patients will be randomly assigned in a 1:1 ratio to the intervention group (n=43) or control group (n=43) using block randomization.
Participants assigned to the intervention group will receive routine care and perform the box breathing technique approximately five minutes before chest tube removal. The technique consists of four phases of equal duration: inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding after exhalation for 4 seconds. Participants will perform 15 consecutive cycles for approximately five minutes under the verbal guidance of the researcher. The exercise will be completed immediately before chest tube removal. Participants in the control group will receive routine clinical care without an additional nonpharmacological intervention.
Pain intensity will be assessed using the Visual Analog Scale (VAS), anxiety using the Visual Analog Scale for Anxiety (VAS-A), and dyspnea using the Visual Analog Scale for Dyspnea (VAS-D). Hemodynamic parameters will include systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation (SpO2).
Assessments will be performed at five time points: before the box breathing intervention (T0), immediately after chest tube removal (T1), and at 5 minutes (T2), 15 minutes (T3), and 30 minutes (T4) after chest tube removal. Both groups will continue to receive routine medical treatment and nursing care throughout the study.
The primary outcome is pain intensity associated with chest tube removal. Secondary outcomes are anxiety, dyspnea, systolic blood pressure, diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's planned enrollment of 86 is above the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Mersin University is the lead sponsor of 178 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this group will perform the box breathing technique in addition to routine care. Approximately five minutes before chest tube removal, participants will perform 15 cycles of the 4-4-4-4 box breathing technique, consisting of inhaling for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding after exhalation for 4 seconds.
Behavioral: Box breathing
Participants in this group will receive routine medical treatment and nursing care without any additional nonpharmacological intervention related to chest tube removal.
Participants will perform the 4-4-4-4 box breathing technique approximately five minutes before chest tube removal. The technique consists of inhaling through the nose for 4 seconds, holding the breath for 4 seconds, exhaling for 4 seconds, and holding after exhalation for 4 seconds. Participants will perform 15 consecutive cycles for approximately five minutes under the verbal guidance of the researcher. The intervention will be completed immediately before chest tube removal. Routine medical treatment and nursing care will continue throughout the intervention.
Pain Intensity
Pain intensity will be assessed using a 10-cm Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain). Higher scores indicate greater pain intensity.
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Anxiety Level
Anxiety will be assessed using the 10-cm Visual Analog Scale for Anxiety (VAS-A), ranging from 0 (no anxiety) to 10 (highest possible anxiety). Higher scores indicate greater anxiety.
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Dyspnea Level
Dyspnea will be assessed using the 10-cm Visual Analog Scale for Dyspnea (VAS-D), ranging from 0 (no dyspnea) to 10 (worst imaginable dyspnea). Higher scores indicate greater dyspnea.
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Systolic Blood Pressure
Systolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Diastolic Blood Pressure
Diastolic blood pressure will be measured using a bedside patient monitor and recorded in millimeters of mercury (mmHg).
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Heart Rate
Heart rate will be measured using a bedside patient monitor and recorded as beats per minute (beats/min).
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Respiratory Rate
Respiratory rate will be assessed by the researcher by observing and counting chest movements for one minute and will be recorded as breaths per minute.
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Peripheral Oxygen Saturation (SpO2)
Peripheral oxygen saturation (SpO2) will be measured using a bedside patient monitor and recorded as a percentage (%).
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Plan to share: No — Individual participant data (IPD) will not be shared due to participant confidentiality and data protection considerations. Aggregate study findings will be reported in scientific publications.
Started Oct 2026 (actual). Primary completion is estimated for Oct 2027, 12 months after the start.
Of 3,731 non-industry interventional studies with no phase under Pain, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 23. This study's planned 12 months is above that.
Counting every sponsor, half of 3,830 studies reached it within 10 months; a quarter within 4 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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