NCT07549555

Brief Summary

This study was conducted to determine the effects of a manual vibration technique applied to the chest wall on the duration of chest tube placement, secretion clearance, and hemodynamic parameters in patients with chest tubes.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Start

First participant enrolled

October 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 24, 2026

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

April 24, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

April 16, 2026

Last Update Submit

April 16, 2026

Conditions

Keywords

Thoracic surgeryChest tubesChest wall oscillationPhysical therapy modalitiesPostoperative careAirway Clearance Techniques

Outcome Measures

Primary Outcomes (1)

  • Patient Follow-Up Form

    Changes in respiratory and hemodynamic parameters (including respiratory rate, peripheral oxygen saturation, heart rate, blood pressure), dyspnea severity (Modified Borg Scale), and pain intensity (Visual Numeric Rating Scale) measured before the intervention and at 0, 1, 5, 10, and 15 minutes after the intervention.

    1 day

Secondary Outcomes (2)

  • Post-Operative Respiratory Status Questionnaire

    1 day

  • Questionnaire on manual chest wall vibration therapy

    1 day

Study Arms (2)

Chest Wall Oscillation Group

ACTIVE COMPARATOR

Postoperative patients with chest tubes received manual chest wall vibration in addition to routine nursing care twice daily (morning and evening). Before the intervention, patients were informed and provided written consent. Baseline measurements included dyspnea (Modified Borg Scale), pain (VNRS), vital signs, and arterial blood gas values. The intervention was performed in semi-Fowler's position during the expiratory phase, applying gentle vibrations from lower to upper lobes for approximately 5 minutes (10 breathing cycles). Patients were guided to use slow nasal inhalation and pursed-lip exhalation. Outcomes were reassessed at 3rd, 5th, and 10th minutes after the intervention. The same procedure was repeated in the evening, and all data were recorded.

Procedure: Chest Wall Oscillation

Conventional Control Group

SHAM COMPARATOR

Control group patients were informed about the study and provided written consent. They received only routine nursing care without any additional intervention. At baseline (0 min), Patient Identification and Follow-up Forms were completed. Dyspnea was assessed using the Modified Borg Scale (MBS), pain using the Visual Numeric Rating Scale (VNRS), and vital signs and arterial blood gas values were recorded. Following routine care, measurements of vital signs, blood gases, dyspnea, and pain were repeated at 0, 3, 5, and 10 minutes and documented. Unlike the intervention group, no manual chest wall vibration was applied, and standard clinical follow-up was maintained. The same monitoring and recording procedures were repeated in the evening session.

Behavioral: Conventional Control

Interventions

Manual chest wall vibration is applied with the patient in a semi-Fowler's position during the expiratory phase of breathing. The practitioner places both hands flat on the chest wall and delivers gentle, rhythmic vibrations, starting from the lower lobes and progressing toward the upper lobes. Patients are instructed to inhale slowly through the nose and exhale using a pursed-lip breathing technique with a 1:2 inspiration-expiration ratio. The procedure is performed for approximately 5 minutes, corresponding to about 10 respiratory cycles, and is typically applied during the patient's rest period following routine care.

Chest Wall Oscillation Group

Control group patients were informed about the study and provided written consent. They received only routine nursing care, with no additional interventions applied. Baseline measurements were taken at 0 minutes, including dyspnea (MBS), pain (VNRS), vital signs, and arterial blood gas values. Following routine care, the same parameters were reassessed at 3, 5, and 10 minutes and recorded. No manual chest wall vibration was performed; only standard clinical monitoring was maintained. The same assessment protocol was repeated in the evening session.

Conventional Control Group

Eligibility Criteria

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

You may qualify if:

  • Having undergone thoracic surgery
  • Having a chest tube in the postoperative period
  • Being hemodynamically stable
  • Agreeing to participate in the study
  • Being open to communication and cooperation

You may not qualify if:

  • Severe cardiac instability
  • Patients unable to tolerate the procedure due to neurological or cognitive impairment
  • Clinical conditions that would prevent the application of vibration to the chest wall
  • Patients diagnosed with pneumonia
  • Patients with a newly implanted transvenous or subcutaneous pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Health Sciences, Saglik Bilimleri University

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Thoracic Diseases

Interventions

Chest Wall Oscillation

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiratory TherapyTherapeutics

Study Officials

  • Sibel YILMAZ SAHİN, Assoc Prof

    Institute of Health Sciences, Saglik Bilimleri University

    STUDY DIRECTOR
  • Beyza SU, MSc.

    Institute of Health Sciences, Saglik Bilimleri University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel YİLMAZ SAHİN, Assoc Prof

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Conventional control group will have regular nursing cares and outcome assessments will be performed by a investigator who was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two groups with a conventional control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc., Nurse

Study Record Dates

First Submitted

April 16, 2026

First Posted

April 24, 2026

Study Start

October 1, 2025

Primary Completion

April 1, 2026

Study Completion

May 1, 2026

Last Updated

April 24, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations