- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06923982
The Effect of Using Virtual Reality Glasses on Post-Care Pain and Comfort Level in Intensive Care Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
The aim of this study is to determine the level of pain and comfort associated with the implementation of virtual reality prior to nursing care in patients undergoing treatment in the intensive care unit.
The study will be conducted in the Internal Medicine Intensive Care Unit of a university hospital. The study population will consist of patients admitted to the internal medicine unit who are between 18 and 65 years of age, are conscious with a Glasgow Coma Scale (GCS) score of 10 or above, have no auditory or visual impairments, and are not receiving mechanical ventilation support.
A total of 60 patients will be included in the study and randomly assigned into two groups: 30 in the experimental group and 30 in the control group.
Data will be collected through face-to-face interviews using a Sociodemographic Characteristics and Information Description Form, a Visual Analog Scale (VAS), and the General Comfort Scale - Short Form (GCS-SF).
The intervention for the experimental group will include viewing calming videos using a virtual reality headset before nursing care. Pain and general comfort levels will be evaluated 24 hours after the nursing care procedure.
Statistical analyses such as percentage calculations, t-test, Mann-Whitney U test, and Spearman correlation analysis will be used to evaluate the data.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Çankırı, Turkey
- Çankırı Karatekin Üniversitesi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individuals who are hospitalized in the intensive care unit (with diagnoses such as cancer, chronic renal failure, heart failure, gastrointestinal bleeding, COPD, DM, etc.) and volunteer to participate in the study.
- Between the ages of 18-65,
- Having clear consciousness, orientation to place, time and person, and having a GCS score of 10 and above,
- Individuals who do not have any hearing or visual impairment,
- They were determined as individuals who were not on mechanical ventilation support.
Exclusion Criteria:
- Receiving mechanical ventilation support
- Individuals under 18 years of age and over 65 years of age
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: virtual reality
During care, patients are given a duration of 3-10 minutes.
virtual reality glasses (VR box 2.0 virtual glasses) for a total of 15 minutes walks in parks, nature and seaside with music background, with reality glasses (6.5 inches), videos that the patient wants to watch and whenever he/she wants, such as underwater or museum tours.
Videos that could be changed were shown.
|
Socio-demographic characteristics form questions were asked to individuals in the intervention group before care.
During the care, patients are given virtual reality glasses (VR box 2.0 virtual reality glasses and 6.5 inch) for a total of 15 minutes, ranging from 3 to 10 minutes, and watch videos that the patient wants to watch, such as park, nature and seaside walks, undersea and museum trips, with a music background.
and he was shown videos that he could change at any time.
After the maintenance, Visual Analog Scale-Pain (VAS-P) scale, General Comfort Level Scale and Satisfaction Evaluation Scale for Virtual Reality Glasses Application questions were applied.
24 hours after the care, VAS-P and General Comfort Level Scale were administered again.
A socio-demographic questionnaire was administered to the control group before care.
During maintenance, no intervention was applied and standard care in routine practice was applied.
After the care, Visual Analog Scale-Pain (VAS-P) scale and General Comfort Scale were applied.
24 hours after the treatment, the Visual Analog Scale-Pain (VAS-P) scale and the General Comfort Scale were applied again.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Pain Level Measured by Visual Analog Scale (VAS) Before and After Nursing Care
Time Frame: 24 hours
|
Pain will be assessed using the Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst imaginable pain).
Higher scores indicate worse pain.
Pain levels will be measured before care and again 24 hours after nursing care, and compared between the experimental and control groups.
|
24 hours
|
|
Change in Overcoming Problems Sub-dimension and General Comfort Level (GCS-SF) After Virtual Reality Application
Time Frame: 24 hours
|
Comfort will be assessed using the General Comfort Scale - Short Form (GCS-SF), including the "overcoming problems" sub-dimension.
The GCS-SF total score ranges from 24 to 96, with higher scores indicating greater comfort.
Scores will be measured 24 hours after the virtual reality application in both the experimental and control groups.
|
24 hours
|
|
Change in Refreshment/Comfort Sub-Dimension Scale Score After Virtual Reality Application
Time Frame: 24 hours
|
Comfort will be evaluated using the Refreshment/Comfort sub-dimension of the General Comfort Scale - Short Form (GCS-SF).
Scores range from 8 to 32, with higher scores indicating greater comfort.
Scores will be measured 24 hours after the virtual reality application in both the experimental and control groups.
|
24 hours
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction Survey Score Related to the Use of Virtual Reality Glasses in the Experimental Group
Time Frame: 24 hours
|
Participants in the experimental group will wear virtual reality glasses during nursing care.
Their satisfaction will be evaluated through a self-report questionnaire using a scale ranging from 0 (not satisfied at all) to 10 (extremely satisfied).
Higher scores indicate greater satisfaction.
The survey will be administered 24 hours after the intervention.
|
24 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- CankırıKU-HEM-ES-01
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 Heart Failure
-
Indiana UniversityRecruitingCongestive Heart Failure | Congestive Heart Failure (CHF) | Congestive Heart Failure Chronic | Congestive Heart Failure(CHF)United States
-
University of Health Sciences LahoreRecruitingAcute Decompensated Heart Failure | Heart Failure, Diastolic | Heart Failure, SystolicPakistan
-
Tufts Medical CenterMetro West Medical CenterCompletedCongestive Heart Failure | Diastolic Heart Failure | Systolic Heart FailureUnited States
-
Abbott Medical DevicesCompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure NYHA Class II | Heart Failure NYHA Class III | Heart Failure With Reduced Ejection Fraction | Heart Failure NYHA Class IV | Heart Failure With Normal Ejection Fraction | Heart Failure; With Decompensation | Heart Failure...United States, Canada
-
Manipal UniversityUnknownHeart Failure | Decompensated Heart Failure | Acute Heart Failure | Diastolic Heart Failure | Systolic Heart FailureIndia
-
Lakeland Regional Health Systems, Inc.RecruitingHeart Failure | Heart Failure Acute | Acute Heart Failure (AHF) | Heart Failure - NYHA II - IVUnited States
-
VA Eastern Colorado Health Care SystemNational Institute on Aging (NIA)CompletedHeart Failure | Heart Failure, Diastolic | Heart Failure, Systolic | Heart Failure With Reduced Ejection Fraction | Heart Failure With Preserved Ejection Fraction | Heart Failure; With Decompensation | Heart Failure,Congestive | Heart Failure AcuteUnited States
-
Eli Lilly and CompanyNot yet recruitingHeart Failure | Heart Failure, Diastolic | Heart Failure, SystolicUnited States, Japan
-
Wake Forest UniversityCompletedHeart Failure, Congestive | Heart Failure With Preserved Ejection Fraction
-
Wake Forest UniversityNational Institute on Aging (NIA)CompletedHeart Failure, Congestive | Diastolic Heart FailureUnited States
Clinical Trials on virtual reality, experimental group
-
Lille Catholic UniversityNot yet recruitingAnorexia Nervosa | Dysmorphophobia
-
University of BeykentCompletedPain | Anxiety | FearTurkey
-
Northwestern UniversityRecruitingPain, ChronicUnited States
-
Cardenal Herrera UniversityUniversity of Valencia; Clinica Universidad de Navarra, Universidad de NavarraCompletedChronic Low Back Pain (CLBP)Spain
-
Mersin UniversityCompletedPain and AnxietyTurkey (Türkiye)
-
Giresun UniversityCompleted
-
Amasya UniversityCompletedPain Management | Percutaneous Coronary Intervention | Virtual Reality | Nursing Caries | CryotherapyTurkey
-
Central Hospital, Nancy, FranceCompleted
-
Cairo UniversityCompletedChildren After Open Heart SurgeryEgypt
-
Universidade do Oeste PaulistaUnknownCardiovascular Diseases | Body CompositionBrazil