- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07457788
Virtual Reality Forest Sounds and Patient Outcomes During Chest Tube Removal
The Effect of Nature Sounds in a Virtual Reality Forest During Chest Tube Removal on Pain, Vital Signs, Comfort, and Patient Satisfaction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type: This research will be conducted using a pretest-posttest, randomized controlled experimental design.
Demographic Information Form This form, developed by the researcher, includes patient age, gender, education level, diagnosis, and information regarding the location of the chest tube placement.
Visual Analog Scale (Pain) Created by Price et al. (1983), this scale ranges from 0, defined as "No pain," to 10, defined as "Unbearable pain." Patients are asked to score their pain between 0 and 10, representing the intensity of the pain they experience .
Patient Satisfaction Scale A satisfaction scale was developed to assess patients' satisfaction with the chest tube removal procedure. Patients will be asked to rate their satisfaction on a scale from 0 to 10.
Vital Signs Monitoring Form This form records the patient's vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, and peripheral oxygen saturation) before and after chest tube removal.
Comfort Scale A 0-10 scale, where one end represents "Most comfortable" and the other end represents "Most uncomfortable." The number marked by the patient indicates their level of comfort.
The researcher will identify patients in the thoracic surgery ward who are scheduled for chest tube removal and meet the sample criteria, in order to collect data for the intervention and control groups. In the ward, 28 Fr chest tubes are generally used, but 32 Fr tubes may also be applied depending on the patient's condition. The decision to remove the chest tubes is made by the responsible physician after reviewing the patient's chest X-ray following the ward visit. Chest tube removal is performed by assistant doctors in the procedure room of the ward. The assignment of participating patients to either the control or intervention group will be determined by randomization.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ayça Uzun
- Phone Number: +905376087592
- Email: acyauzun98@hotmail.com
Study Locations
-
-
Kadıköy
-
Istanbul, Kadıköy, Turkey (Türkiye), 34668
- Recruiting
- Dr. Siyami Ersek Cardiovascular and Thoracic Surgery Training and Research Hospital
-
Contact:
- Ayça Uzun, MSc student
- Phone Number: +90 5376087592
- Email: acyauzun98@hotmail.com
-
Contact:
- Hatice Demirdağ, PhD
- Phone Number: +90 5057612213
- Email: hatice.demirdag@uskudar.edu.tr
-
Principal Investigator:
- Ayça Uzun, MSc Student
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Able to speak and understand Turkish
- Willing to participate in the study
- Aged 18 years or older
- No auditory or visual impairments
Exclusion Criteria:
- Patients with impaired orientation to time and place
- Patients with migraine, vertigo, or dizziness
- Illiterate patients
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Virtual Reality with Nature Sounds
Data for the intervention group will be collected using the same data collection tools and time points as the control group, with the addition of the virtual reality (VR) application.
The Patient Demographic Form will be administered 15 minutes before chest tube removal.
Ten minutes before the procedure, patients will complete the Visual Analog Scale (Pain) and Vital Signs Monitoring Form.
Patients will be informed about the procedure.
Before the attending assistant physician arrives, the VR headset and headphones will be placed on the patient, and the patient will be positioned appropriately.
During the procedure, the patient will view a virtual forest environment and listen to nature sounds for 5-10 minutes.
Pain will be assessed immediately after the procedure.
Ten minutes after the procedure, pain, patient satisfaction, vital signs, and comfort levels will be evaluated using the corresponding scales.
|
During chest tube removal, the patient will wear a VR headset and headphones to view a virtual forest environment and listen to nature sounds; pain, vital signs, comfort, and patient satisfaction will be assessed during this period.
|
|
No Intervention: Control Group
For patients assigned to the control group, 15 minutes before chest tube removal, only the Patient Demographic Form will be administered, without any intervention beyond the clinical protocol.
Ten minutes before the procedure, patients will complete the Visual Analog Scale (Pain) and Vital Signs Monitoring Form.
Patients will be informed about the procedure.
They will be placed in a semi-Fowler position and asked to raise their arms upward.
Once positioned correctly, patients will be instructed to take a deep breath and hold it while the chest tube is removed.
Pain will be assessed immediately after the procedure.
Ten minutes after the procedure, pain, patient satisfaction, comfort, and vital signs will be evaluated using the respective scales.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain level during chest tube removal
Time Frame: Pain levels will be measured 10 minutes before chest tube removal, immediately after removal, and 10 minutes after removal.
|
Patient pain status is determined using the Visual Analog Scale (VAS).
A score of 0 indicates 'no pain,' and a score of 10 indicates 'worst possible pain.'
Higher scores indicate worse outcomes
|
Pain levels will be measured 10 minutes before chest tube removal, immediately after removal, and 10 minutes after removal.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
vital signs- Heart Rate
Time Frame: 10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
Heart rate is measured in beats per minute, indicating a physiological response to pain and anxiety.
The normal range for adults is typically 60 to 100 bpm.
|
10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
|
Vital signs- Respiratory Rate
Time Frame: 10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
Respiratory rate is measured in breaths per minute to assess the physiological response to pain and increased anxiety.
The normal range for adults is typically 12 to 20 breaths/minute.
|
10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
|
Patient Satisfaction
Time Frame: The patient satisfaction scale will be administered 10 minutes after the chest tube removal.
|
A satisfaction scale related to the chest tube removal procedure has been created for the patients.
They will be asked to rate their satisfaction between 0 and 10.
On the patient satisfaction scale, a score of 0 indicates 'Not satisfied at all,' while a score of 10 indicates 'Very satisfied'.
|
The patient satisfaction scale will be administered 10 minutes after the chest tube removal.
|
|
Patient comfort level
Time Frame: The comfort level is asked to the patient 10 minutes after chest tube removal for both the control and VR groups
|
It is a scale ranging from 0 to 10 points.
One end of the scale indicates 'maximum comfort,' while the other end indicates 'maximum discomfort.'
The number marked reflects the level of comfort.
On the Comfort Scale, a score of 0 indicates the 'most comfortable state,' while a score of 10 indicates the 'most uncomfortable state.'
Higher scores indicate worse outcomes (discomfort)
|
The comfort level is asked to the patient 10 minutes after chest tube removal for both the control and VR groups
|
|
Vital Signs- Peripheral Oxygen Saturation (SpO₂)
Time Frame: 10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
Peripheral Oxygen Saturation is measured via pulse oximetry, reflecting potential changes in respiratory function due to pain and anxiety.
Normal saturation levels are generally considered 95% and above.
|
10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
|
Vital Signs- Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
Time Frame: 10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
Systolic Blood Pressure is measured in millimeters of mercury (mmHg), reflecting the effects of pain and stress on the cardiovascular system.
Diastolic Blood Pressure is measured in millimeters of mercury (mmHg), reflecting the effects of pain and stress on the cardiovascular system.
Normal systolic pressure is generally considered less than 120 mmHg.
Normal diastolic pressure is generally considered less than 80 mmHg.
|
10 minutes before chest tube removal and 10 minutes after chest tube removal.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AYCA16202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Virtual Reality
-
The Cleveland ClinicRecruitingEndoscopy | Virtual Reality | Ergonomics | Virtual Reality HeadsetUnited States
-
Royal National Orthopaedic Hospital NHS TrustNot yet recruitingVirtual Reality | Education, Medical | Virtual Reality Simulation
-
Cairo UniversityCompletedVirtual Reality | Pediatric Burn | Immersive Virtual Reality | Passive Virtual RealityEgypt
-
Stanford UniversityRecruitingVirtual Reality | Augmented RealityUnited States
-
National Taiwan University HospitalRecruiting
-
National Taiwan University HospitalNot yet recruiting
-
The Methodist Hospital Research InstituteNational Institute on Aging (NIA)CompletedVirtual RealityUnited States
-
Charles River AnalyticsNational Institute of Environmental Health Sciences (NIEHS); The New England...Completed
-
Ardahan UniversityCompleted
Clinical Trials on Virtual Reality with Nature Sounds
-
Sümeyye BALCompleted
-
Selcuk UniversityCompletedAnxiety | Preterm Birth | Virtual Reality | Psychological Stress | Prenatal Attachment | PleasureTurkey
-
Amasya UniversityNot yet recruitingPregnancy - Prenatal Testing
-
Heart and Brain Research Group, GermanyNot yet recruitingStress | Virtual Reality | Relaxation | Binaural Beats
-
Acibadem UniversityCompletedEffects of Nature-Based Virtual Reality and 2D Nature Videos on OSCE Exam Stress in Nursing StudentsStress | Virtual Reality | Students | NursingTurkey (Türkiye)
-
University of PadovaOspedale S.Bortolo -Vicenza, Italy; University of Salerno, ItalyRecruiting
-
University of MalagaNot yet recruitingLow Back Pain | Pelvic Pain
-
Hospital Israelita Albert EinsteinTerminatedPain | Breast PainBrazil
-
University of ChicagoActive, not recruitingBreast CancerUnited States
-
Maharishi Markendeswar University (Deemed to be...CompletedAnxiety | Agitated; State, Acute Reaction to Stress