Turkey, Mersin University Hospital
Yenişehir, Mersin, 33120, Turkey (Türkiye)
NCT Number: NCT07808658
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Yenişehir, Mersin, 33120, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 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
Exclusion criteria
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 Having four chest tubes (two mediastinal and two thoracic) Unwilling to participate in the study Having a diagnosed psychiatric disorder or mental health condition
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.
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.
Time frame: Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.
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 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 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 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 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 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) will be measured using a bedside patient monitor and recorded as a percentage (%).
Contact information is provided by the study sponsor or research team.
TUGBA ÇAM YANIK, PHD, RN
CONTACT
Tuğba ÇAM YANIK, PHD
CONTACT
Mersin University
Other
The Effect of Box Breathing Before Chest Tube Removal After Open-Heart Surgery on Pain, Anxiety, Dyspnea, and Hemodynamic Parameters: A Randomized Controlled Trial
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