Open-Heart SurgeryNCT07808658
Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery
A study testing Box breathing in people with Open-Heart Surgery, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open-Heart Surgery
- What is being tested?
- Box breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Oct 2026to 30 Oct 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
- Patients who have undergone open-heart surgery and have a chest tube
- Aged 18 years or older
- Willing to participate in the study and providing written informed consent
- Conscious, oriented, and cooperative
- Able to read and understand Turkish
- Clinically and hemodynamically stable
Show all 9Show fewer
- Having no more than three chest tubes (up to two mediastinal and one thoracic chest tube)
- No diagnosed psychiatric disorder
- Not receiving psychiatric medications and/or local neuromuscular blocking agents
Who cannot join
- Patients who have not undergone open-heart surgery
- Unconscious, disoriented, or uncooperative patients
- Unable to read and understand Turkish
- Intubated patients
- Receiving additional analgesic medication other than routine analgesia
- Receiving local anesthesia at the chest tube insertion site
Show all 9Show fewer
- Having four chest tubes (two mediastinal and two thoracic)
- Unwilling to participate in the study
- Having a diagnosed psychiatric disorder or mental health condition
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Turkey, Mersin University Hospital
Yenişehir, Mersin, 33120
Tuğba ÇAM YANIK, PhD, 05067703216, tugbacam@mersin.edu.tr
About this study
Official title: The Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery on Pain, Anxiety, Dyspnea, and Hemodynamic Parameters: A Randomized Controlled Trial
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.
Read the detailed description
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.
- Conditions
- Open-Heart Surgery
- Being tested
- Box breathing
- Keywords
- Box Breathing, Chest Tube Removal, Open-Heart Surgery, Pain, Anxiety, Dyspnea, Hemodynamic Parameters, Nonpharmacological Intervention
- Medical subject headings
- Pain, Anxiety Disorders, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Box breathingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Box Breathing Group | Experimental | 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. Receives: Behavioral: Box breathing |
| Control Group | No intervention | Participants in this group will receive routine medical treatment and nursing care without any additional nonpharmacological intervention related to chest tube removal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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 (%).
Measured: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after 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 posted9 Sep 2026
- Study start22 Oct 2026
- Primary completion22 Oct 2027 (estimated)
- Study completion30 Oct 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 Open-Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Mersin UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugba CAM YANIK, Mersin University
- Investigators
- Tuğba ÇAM YANIK, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808658
- Sponsor's protocol ID
- Mersin_Unıvers
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
McAllister MJ, Martaindale MH, Sutton N, Andersen JP. Box breathing and prolonged exhalation reduces markers of physiological stress reactivity in response to a virtual trier social stress test. Compr Psychoneuroendocrinol. 2026 Jun 25;27:100360. doi: 10.1016/j.cpnec.2026.100360. eCollection 2026 Aug.
PubMed 42388906Jarrah MI, Hweidi IM, Al-Dolat SA, Alhawatmeh HN, Al-Obeisat SM, Hweidi LI, Hweidi AI, Alkouri OA. The effect of slow deep breathing relaxation exercise on pain levels during and post chest tube removal after coronary artery bypass graft surgery. Int J Nurs Sci. 2022 Mar 15;9(2):155-161. doi: 10.1016/j.ijnss.2022.03.001. eCollection 2022 Apr.
PubMed 35509699
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery on Pain, Anxiety, Dyspnea, and Hemodynamic Parameters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07808658
- Acronym / sponsor ID
- Mersin_Unıvers
- Conditions
- Open-Heart Surgery
- Keywords
- Box Breathing, Chest Tube Removal, Open-Heart Surgery, Pain, Anxiety, Dyspnea, Hemodynamic Parameters, Nonpharmacological Intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 22 Oct 2026 (actual)
- Primary completion
- 22 Oct 2027 (estimated)
- Study completion
- 30 Oct 2027 (estimated)
- First posted
- 9 Sep 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Box Breathing Group | Experimental | Behavioral: Box breathingParticipants 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. |
| Control Group | No intervention | –Participants in this group will receive routine medical treatment and nursing care without any additional nonpharmacological intervention related to chest tube removal. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients who have undergone open-heart surgery and have a chest tube
- Aged 18 years or older
- Willing to participate in the study and providing written informed consent
- Conscious, oriented, and cooperative
- Able to read and understand Turkish
Key exclusion criteria (9 listed)
- Patients who have not undergone open-heart surgery
- Unconscious, disoriented, or uncooperative patients
- Unable to read and understand Turkish
- Intubated patients
- Receiving additional analgesic medication other than routine analgesia
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 |
|---|---|---|
| Box breathingParticipants 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. | Behavioural | Box Breathing Group |
Primary outcome
Pain Intensity
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
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.
7 secondary outcomes
Anxiety Level
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Dyspnea Level
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Systolic Blood Pressure
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Diastolic Blood Pressure
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Heart Rate
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Respiratory Rate
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
Peripheral Oxygen Saturation (SpO2)
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
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 4 Nov 2026.
- Background: PubMed 42388906McAllister MJ, Martaindale MH, Sutton N, Andersen JP. Box breathing and prolonged exhalation reduces markers of physiological stress reactivity in response to a virtual trier social stress test. Compr Psychoneuroendocrinol. 2026 Jun 25;27:100360. doi: 10.1016/j.cpnec.2026.100360. eCollection 2026 Aug.
- Background: PubMed 35509699Jarrah MI, Hweidi IM, Al-Dolat SA, Alhawatmeh HN, Al-Obeisat SM, Hweidi LI, Hweidi AI, Alkouri OA. The effect of slow deep breathing relaxation exercise on pain levels during and post chest tube removal after coronary artery bypass graft surgery. Int J Nurs Sci. 2022 Mar 15;9(2):155-161. doi: 10.1016/j.ijnss.2022.03.001. eCollection 2022 Apr.
- Individual participant dataSharing planned: 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.
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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.
Tuğba ÇAM YANIK principal investigator
Mersin University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Box breathing in people with Open-Heart Surgery, run by Mersin University at 1 site in Turkey (Türkiye).
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 9 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Tuğba ÇAM YANIK, PHD (05067703216, tugbacam@mersin.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.). 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 NCT07808658, 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 4 Nov 2026.