CopdNCT06923982
The Effect of Using Virtual Reality Glasses on Post-Care Pain and Comfort Level in Intensive Care Patients
A study testing virtual reality, experimental group in people with Copd and Heart Failure, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
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 research will be conducted in the Internal Medicine Intensive Care Unit of a university hospital. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Copd, Heart Failure, Intensive Care Unit Syndrome
- What is being tested?
- virtual reality, experimental group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 15 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Receiving mechanical ventilation support
- Individuals under 18 years of age and over 65 years of age
Trial locations and contacts
1 site in 1 country.
About this study
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 research will be conducted in the Internal Medicine Intensive Care Unit of a university hospital.
Read the 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.
- Conditions
- Copd, Heart Failure, Intensive Care Unit Syndrome, Renal Failure, Gastro Esophageal Reflux
- Being tested
- virtual reality, experimental group, control group
- Keywords
- nursing, virtual reality, pain, comfort, intensive care unit
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Heart Failure, Renal Insufficiency, Gastroesophageal Reflux, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality, experimental groupOther
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.
control groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| virtual reality | Other | 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. Receives: Other: virtual reality, experimental group; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Level Measured by Visual Analog Scale (VAS) Before and After Nursing Care
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.
Measured: 24 hours
Change in Overcoming Problems Sub-dimension and General Comfort Level (GCS-SF) After Virtual Reality Application
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.
Measured: 24 hours
Change in Refreshment/Comfort Sub-Dimension Scale Score After Virtual Reality Application
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2025
- Study start1 Jul 2022
- Primary completion31 Dec 2022
- Study completion15 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Two groups were taken as experimental and control groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Şahin, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06923982
- Sponsor's protocol ID
- CankırıKU-HEM-ES-01
- Status last verified
- Apr 2025
- First submitted
- 21 Mar 2024
- Last updated
- 11 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality Glasses on Post-Care Pain and Comfort Level in Intensive Care Patients
- ClinicalTrials.gov ID
- NCT06923982
- Acronym / sponsor ID
- CankırıKU-HEM-ES-01
- Conditions
- Copd, Heart Failure, Intensive Care Unit Syndrome, Renal Failure, Gastro Esophageal Reflux
- Keywords
- nursing, virtual reality, pain, comfort, intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 15 Jan 2024 (actual)
- First posted
- 11 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 research will be conducted in the Internal Medicine Intensive Care Unit of a university hospital.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Two groups were taken as experimental and control groups
| Arm | Type | Receives |
|---|---|---|
| virtual reality | Other | Other: virtual reality, experimental group, Other: control groupDuring 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Receiving mechanical ventilation support
- Individuals under 18 years of age and over 65 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| virtual reality, experimental groupSocio-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. | Other | virtual reality |
| control groupA 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. | Other | virtual reality |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality, experimental group in people with Copd and Heart Failure, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Level Measured by Visual Analog Scale (VAS) Before and After Nursing Care (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2025.