Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 12:30 AM
Study NCT ID:
NCT07327957
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-09
First Post:
2025-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014732', 'term': 'Vibration'}, {'id': 'D001945', 'term': 'Breathing Exercises'}], 'ancestors': [{'id': 'D055595', 'term': 'Mechanical Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026241', 'term': 'Exercise Movement Techniques'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-08-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-08', 'studyFirstSubmitDate': '2025-12-26', 'studyFirstSubmitQcDate': '2025-12-26', 'lastUpdatePostDateStruct': {'date': '2026-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity', 'timeFrame': 'Assessed immediately before chest tube removal and 10 minutes after the procedure.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Anxiety Level', 'timeFrame': 'Assessed immediately before chest tube removal and 10 minutes after the procedure.', 'description': 'Anxiety levels will be measured using the State Anxiety Inventory (State-Trait Anxiety Inventory - State subscale), a validated self-report questionnaire designed to assess situational anxiety. Higher scores indicate higher levels of anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postoperative Pain', 'Anxiety', 'Thoracic Drainage']}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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.", 'detailedDescription': 'Chest tube removal is a necessary clinical procedure following thoracic surgery, but it is frequently associated with acute pain and heightened anxiety. These symptoms may negatively affect patient comfort, cooperation, and recovery. While pharmacological interventions are commonly used to manage procedure-related pain and anxiety, concerns regarding side effects and limited effectiveness have increased interest in non-pharmacological approaches within nursing care.\n\nThis randomized controlled study is designed to evaluate the effectiveness of vibration and breathing exercises applied prior to chest tube removal on pain and anxiety levels. Eligible adult patients hospitalized in a thoracic surgery unit and scheduled for chest tube removal will be randomly assigned to one of three groups: a vibration group, a breathing exercise group, or a control group receiving routine care. Randomization will be performed using a web-based randomization tool to ensure equal allocation.\n\nIn the vibration group, a portable vibration device will be applied to the area proximal to the chest tube insertion site for a standardized duration before the removal procedure. In the breathing exercise group, participants will be guided through structured breathing exercises designed to promote relaxation and diaphragmatic breathing. The control group will receive standard clinical care without any additional non-pharmacological intervention.\n\nPain intensity and anxiety levels will be assessed at two time points: prior to the chest tube removal procedure and shortly after the procedure. Validated measurement tools will be used to ensure reliability of the findings. Data will be analyzed to compare changes in pain and anxiety levels within and between groups.\n\nThe results of this study are expected to provide evidence regarding the use of vibration and breathing exercises as simple, safe, and cost-effective nursing interventions to reduce pain and anxiety associated with chest tube removal. These findings may contribute to the development of evidence-based, non-pharmacological strategies in clinical nursing practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients aged 18 years and older\n* Hospitalized patients with an indwelling chest tube scheduled for removal\n* First-time chest tube placement\n* Conscious, oriented, and cooperative\n* Able to understand and communicate in Turkish\n* Hemodynamically stable at the time of chest tube removal\n* No use of analgesic or sedative medications within 4 hours prior to the procedure\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* History of any cognitive or psychiatric disorder\n* Previous experience with chest tube placement\n* Requirement for mechanical ventilation or endotracheal intubation\n* Presence of chronic pain or regular use of analgesic medications\n* Use of analgesic or sedative medications immediately before chest tube removal\n* Unstable clinical condition at the time of the procedure\n* Refusal or inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT07327957', 'briefTitle': 'Effects of Vibration and Breathing Exercises on Pain and Anxiety During Chest Tube Removal', 'organization': {'class': 'OTHER', 'fullName': 'Ataturk University'}, 'officialTitle': 'The Effect of Vibration and Breathing Exercises Applied Before Chest Tube Removal on Pain and Anxiety: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'CTT-VIBREATH-RCT-ATAU-2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vibration and Breathing Exercise Group', 'description': 'Participants in this group will receive a combined non-pharmacological intervention consisting of vibration application and guided breathing exercises prior to chest tube removal. The vibration will be applied using a portable vibration device to the area proximal to the chest tube insertion site for a standardized duration. Breathing exercises will be performed under the guidance of the researcher and will include slow, deep, and diaphragmatic breathing techniques aimed at promoting relaxation. All interventions will be administered in addition to routine clinical care.', 'interventionNames': ['Other: Vibration and Breathing Exercises']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (Standard Care)', 'description': '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.'}], 'interventions': [{'name': 'Vibration and Breathing Exercises', 'type': 'OTHER', 'description': 'Participants assigned to the intervention group will receive a combined non-pharmacological intervention consisting of vibration application and guided breathing exercises prior to chest tube removal. Vibration will be applied using a portable vibration device placed on the skin near the chest tube insertion site for a standardized duration. The application will be performed while the patient is in a comfortable position.\n\nFollowing the vibration application, participants will be guided through structured breathing exercises, including slow, deep, diaphragmatic, and pursed-lip breathing techniques. These exercises will be conducted by the researcher in a calm and quiet environment to promote relaxation. The combined intervention will be administered in addition to routine clinical care and completed before the chest tube removal procedure.', 'armGroupLabels': ['Vibration and Breathing Exercise Group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Gamze BULUT ÖZLÜ', 'role': 'CONTACT', 'email': 'gamze.bulut@atauni.edu.tr', 'phone': '+905533826019'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gamze BULUT', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ataturk University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Assistant, Department of Surgical Nursing', 'investigatorFullName': 'Gamze BULUT', 'investigatorAffiliation': 'Ataturk University'}}}}