NCT07808658

Brief 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. 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Oct 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Oct 2026Oct 2027

First Submitted

Initial submission to the registry

September 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 9, 2026

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2027

Last Updated

September 11, 2026

Status Verified

September 1, 2026

Enrollment Period

1.1 years

First QC Date

September 2, 2026

Last Update Submit

September 10, 2026

Conditions

Open-Heart Surgery

Keywords

Box BreathingChest Tube RemovalOpen-Heart SurgeryPainAnxietyDyspneaHemodynamic ParametersNonpharmacological Intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

Secondary Outcomes (7)

  • Anxiety Level

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

  • Dyspnea Level

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

  • Systolic Blood Pressure

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

  • Diastolic Blood Pressure

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

  • Heart Rate

    Before the intervention, immediately after chest tube removal, and 5, 15, and 30 minutes after chest tube removal.

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Interventions

Box breathingBEHAVIORAL

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.

Box Breathing Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey, Mersin University Hospital

Yenişehir, Mersin, 33120, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 42388906BACKGROUND

  • Jarrah 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.

    PMID: 35509699BACKGROUND

MeSH Terms

Conditions

PainAnxiety DisordersDyspnea

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Officials

  • Tuğba ÇAM YANIK

    Mersin University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tuğba ÇAM YANIK, PHD

CONTACT

05067703216tugbacam@mersin.edu.tr

TUGBA ÇAM YANIK, PHD, RN

CONTACT

05067703216tugbacam@mersin.edu.tr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Surgical Diseases Nursing

Study Record Dates

First Submitted

September 2, 2026

First Posted

September 9, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

October 30, 2027

Study Completion (Estimated)

October 30, 2027

Last Updated

September 11, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations

TU(1)