NCT07327957

Brief Summary

Removing a chest tube is a common procedure after chest surgery, but it can cause significant pain and anxiety for patients. Although medications can help reduce these symptoms, they may have side effects and are not always sufficient. Therefore, simple and safe non-drug methods are increasingly used to improve patient comfort. This randomized controlled study aims to examine the effects of vibration and breathing exercises applied before chest tube removal on patients' pain and anxiety levels. Adult patients with a chest tube will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving standard care. Pain and anxiety levels will be measured before the procedure and after chest tube removal using validated scales. The findings of this study are expected to show whether vibration and breathing exercises are effective in reducing pain and anxiety during chest tube removal. If effective, these methods may offer nurses an easy, low-cost, and safe way to improve patient comfort and support evidence-based nursing care.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
active not 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 Progress39%
Jun 2026Oct 2026

First Submitted

Initial submission to the registry

December 26, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 8, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

June 15, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2026

Last Updated

July 23, 2026

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

December 26, 2025

Last Update Submit

July 22, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    Pain intensity associated with chest tube removal will be assessed using the Visual Analog Scale (VAS), a validated 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain). Participants will self-report their pain level.

    Assessed immediately before chest tube removal and 10 minutes after the procedure.

Secondary Outcomes (1)

  • Anxiety Level

    Assessed immediately before chest tube removal and 10 minutes after the procedure.

Study Arms (3)

Vibration

EXPERIMENTAL

Participants in this group will receive a non-pharmacological intervention consisting of vibration before chest tube removal. Vibration will be applied proximal to the chest tube insertion site for a standard duration using a portable vibrating device. The interventions will be performed in addition to routine clinical care.

Other: Vibration

Control Group (Standard Care)

NO INTERVENTION

Participants in the control group will receive routine clinical care according to standard hospital protocols prior to chest tube removal. No additional non-pharmacological interventions, including vibration or breathing exercises, will be applied before the procedure.

Breathing Exercise Group

EXPERIMENTAL

Individuals in the breathing exercise group will be led through breathing exercises by the researcher in their room before the procedure begins. The exercise duration is approximately 8-10 minutes. The environment should be quiet, at room temperature, and well-ventilated during the exercises. The patient should be seated in a comfortable position, and the following steps will be followed.

Other: Breathing Exercises

Interventions

Vibration will be applied using a portable data device inserted for a standard duration, combined with chest tube placement. The procedure will be performed with the patient in a comfortable position.

Vibration

The remaining patients will be given breathing exercises including slow, deep, diaphragmatic, and iced-lip breathing techniques. These exercises will be performed calmly and quietly by the researcher to promote relaxation. The combined intervention will continue in addition to routine clinical care until the procedures and chest tube removal expense are completed.

Breathing Exercise Group

Eligibility Criteria

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

You may qualify if:

  • years of age and older,
  • Conscious, oriented, and cooperative (e.g., Glasgow Coma Score ≥ 13),
  • Able to speak and understand Turkish,
  • Having a chest tube and undergoing chest tube removal for the first time,
  • Hemodynamically stable,
  • Having not taken analgesic, sedative, or anxiolytic drugs at least 4 hours prior to the procedure,
  • Able to communicate and respond to pain assessment scales during the procedure,
  • No severe hearing, visual, or communication impairment,
  • No neurological or cognitive disease that could affect the assessment of cognitive functions,
  • No history of psychiatric diagnosis or active psychiatric treatment,
  • Patients who voluntarily participate in the study and provide written consent will be included.

You may not qualify if:

  • Patients with past or current cognitive and psychological disorders,
  • Those who have previously had chest tube insertion,
  • Those who are mechanically ventilated (intubated),
  • Those who have chronic pain and routinely use analgesics,
  • Those who used analgesics immediately before chest tube removal,
  • Those who did not volunteer to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Atatürk Universty

Erzurum, Erzurum, 25000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, PostoperativeAnxiety Disorders

Interventions

VibrationBreathing Exercises

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsMental Disorders

Intervention Hierarchy (Ancestors)

Mechanical PhenomenaPhysical PhenomenaMind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant, Department of Surgical Nursing

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 8, 2026

Study Start

June 15, 2026

Primary Completion (Estimated)

September 15, 2026

Study Completion (Estimated)

October 15, 2026

Last Updated

July 23, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Individual participant data (IPD) will not be shared. The data collected in this study include sensitive health information, and sharing IPD may pose a risk to participant confidentiality and privacy. In addition, the informed consent obtained from participants does not include permission for data sharing beyond the research team. Therefore, IPD will be used solely for the purposes of this study and related scientific

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