Total Knee Replacement SurgeryNCT05668143
Effect of Intraoperative Virtual Reality on Anxiety and Vital Findings in Patients Total Knee Replacement Surgery
A study testing Virtual reality in people with Total Knee Replacement Surgery and Virtual Reality, run by Bucak State Hospital at 1 site in Turkey (Türkiye).
Trial summary
Although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Replacement Surgery, Virtual Reality
- What is being tested?
- Virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2022to 31 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agreed to participate in the research
- Being 18 years or older
- Being able to read and write Turkish
- No vision and hearing problems
- Not using glasses
- Absence of any psychiatric, cognitive or neurological disease
Who cannot join
- Patients with visual or hearing impairment
- Patients receiving general anesthesia
- Those who have previously had total knee replacement surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intraoperative Virtual Reality Application on the Level of Anxiety and Vital Findings in Patients Who Will Have Total Knee Replacement Surgery: A Randomized Controlled Study
Although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake during the surgery. When the literature is examined, there are no pharmacological methods to reduce anxiety.
When distraction techniques are used, patients' anxiety levels are significantly reduced, vital signs are normalized, patient satisfaction is increased and pain is relieved.
It has been emphasized that there is a successful method in reducing One of the distraction techniques is the application of virtual reality. This study will be carried out in a randomized controlled experimental design to determine the effect of virtual reality application during surgery on patients who will undergo total knee replacement surgery, on the anxiety level and vital signs of the patients.
Read the detailed description
The aim of this study is to determine the effect of virtual reality application on patients' anxiety level and vital signs during surgery for patients who will undergo total knee replacement surgery.
It will consist of patients over the age of 18 who will have total knee replacement surgery, which will be carried out in the Operating Room Unit. Patients meeting the sample selection criteria were randomized into experimental and control groups.
will be divided into two groups. Virtual reality glasses will be applied to the experimental group. In the collection of data; "Patient Information Form", "State Anxiety Inventory Scale" and "Vital Signs Follow-up Form" will be used.
- Conditions
- Total Knee Replacement Surgery, Virtual Reality
- Being tested
- Virtual reality
- Keywords
- Intraoperative, Virtual Reality, Anxiety, Vital Findings, Patients, Total Knee Replacement Surgery
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityBehavioural
The Patient Information Form and the State Anxiety Scale will be administered to the patients just before the surgery. The researcher will measure the patient's respiratory, blood pressure, pulse and oxygen saturation values on the monitor just before the start of the operation and every 15 minutes after the operation, and the vital signs will be recorded in the follow-up form. Virtual reality glasses will be put on the patient immediately after anesthesia is given to the patient by the anesthesiologist. Glasses will be worn during the total knee replacement surgery. Total knee replacement surgery takes an average of 60 minutes. During the surgery, patients will be shown nature and landscape images with virtual reality glasses. Virtual reality glasses will be removed immediately after the operation and the State Anxiety Scale and vital signs follow-up form will be applied before the patient is sent to the service from the operating room.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | During the surgery, patients will be shown nature and landscape images with virtual reality glasses. Receives: Behavioral: Virtual reality |
| Control group | No intervention | The control group will receive standard procedure without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
State Anxiety Scale mean scores of the patients in the intervention and control groups will be compared before and after surgery. A minimum of 20 and a maximum of 80 points can be obtained from the scale. If the scale score approaches 80, it indicates high anxiety.
Measured: 10 minute
Respiratory Rate
Just before the start of the operation and every 15 minutes after the operation, the patient's respiratory rate values will be measured on the monitor and the respiratory rate will be recorded in the follow-up form.
Measured: 15 minute
Blood Pressure (both systolic and diastolic blood pressure)
Just before the start of the operation and every 15 minutes after the operation, the patient's blood pressure (both systolic and diastolic blood pressure) values will be measured on the monitor and the blood pressure (both systolic and diastolic blood pressure) will be recorded in the follow-up form.
Measured: 15 minute
Pulse
Just before the start of the operation and every 15 minutes after the operation, the patient's pulse values will be measured on the monitor and the pulse will be recorded in the follow-up form.
Measured: 15 minute
Saturation Value
Just before the start of the operation and every 15 minutes after the operation, the patient's saturation value will be measured on the monitor and the saturation will be recorded in the follow-up form.
Measured: 15 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2022
- Study start30 Dec 2022
- Primary completion10 Apr 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Replacement SurgeryStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients will be divided into two as the experimental and control group.The study will be conducted as a randomized controlled trial. Patients in the experimental group will be informed about the using virtual reality glasses during total knee replacement surgery.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bucak State Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yusuf Beşirik, Bucak State Hospital
- Investigators
- Yusuf Beşirik, MScN student, Principal investigator, Bucak State HospitalSerap Sayar, PhD, Study director, KTO Karatay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05668143
- Sponsor's protocol ID
- 2022/008
- Status last verified
- Feb 2024
- First submitted
- 9 Dec 2022
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intraoperative Virtual Reality Application on the Level of Anxiety and Vital Findings in Patients Who Will Have Total Knee Replacement Surgery: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05668143
- Acronym / sponsor ID
- 2022/008
- Conditions
- Total Knee Replacement Surgery, Virtual Reality
- Keywords
- Intraoperative, Virtual Reality, Anxiety, Vital Findings, Patients, Total Knee Replacement Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bucak State HospitalOther government
- Study start
- 30 Dec 2022 (actual)
- Primary completion
- 10 Apr 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 29 Dec 2022 (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.
Although total knee replacement surgery improves the quality of life of the patients, a significant reduction in knee pain and normalization of the knee joint, the awareness of the surrounding events is a major concern for the patients and negatively affects their vital signs, since most of the patients are awake during the surgery. When the literature is examined, there are no pharmacological methods to reduce anxiety.
When distraction techniques are used, patients' anxiety levels are significantly reduced, vital signs are normalized, patient satisfaction is increased and pain is relieved.
It has been emphasized that there is a successful method in reducing One of the distraction techniques is the application of virtual reality. This study will be carried out in a randomized controlled experimental design to determine the effect of virtual reality application during surgery on patients who will undergo total knee replacement surgery, on the anxiety level and vital signs of the patients.
Detailed description
The aim of this study is to determine the effect of virtual reality application on patients' anxiety level and vital signs during surgery for patients who will undergo total knee replacement surgery.
It will consist of patients over the age of 18 who will have total knee replacement surgery, which will be carried out in the Operating Room Unit. Patients meeting the sample selection criteria were randomized into experimental and control groups.
will be divided into two groups. Virtual reality glasses will be applied to the experimental group. In the collection of data; "Patient Information Form", "State Anxiety Inventory Scale" and "Vital Signs Follow-up Form" will be used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be divided into two as the experimental and control group.The study will be conducted as a randomized controlled trial. Patients in the experimental group will be informed about the using virtual reality glasses during total knee replacement surgery.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Virtual realityDuring the surgery, patients will be shown nature and landscape images with virtual reality glasses. |
| Control group | No intervention | –The control group will receive standard procedure without any intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily agreed to participate in the research
- Being 18 years or older
- Being able to read and write Turkish
- No vision and hearing problems
- Not using glasses
Key exclusion criteria (3 listed)
- Patients with visual or hearing impairment
- Patients receiving general anesthesia
- Those who have previously had total knee replacement surgery
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 realityThe Patient Information Form and the State Anxiety Scale will be administered to the patients just before the surgery. The researcher will measure the patient's respiratory, blood pressure, pulse and oxygen saturation values on the monitor just before the start of the operation and every 15 minutes after the operation, and the vital signs will be recorded in the follow-up form. Virtual reality glasses will be put on the patient immediately after anesthesia is given to the patient by the anesthesiologist. Glasses will be worn during the total knee replacement surgery. Total knee replacement surgery takes an average of 60 minutes. During the surgery, patients will be shown nature and landscape images with virtual reality glasses. Virtual reality glasses will be removed immediately after the operation and the State Anxiety Scale and vital signs follow-up form will be applied before the patient is sent to the service from the operating room. | Behavioural | Experimental group |
Primary outcome
State Anxiety Scale
Time frame: 10 minute
State Anxiety Scale mean scores of the patients in the intervention and control groups will be compared before and after surgery. A minimum of 20 and a maximum of 80 points can be obtained from the scale. If the scale score approaches 80, it indicates high anxiety.
Respiratory Rate
Time frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's respiratory rate values will be measured on the monitor and the respiratory rate will be recorded in the follow-up form.
Blood Pressure (both systolic and diastolic blood pressure)
Time frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's blood pressure (both systolic and diastolic blood pressure) values will be measured on the monitor and the blood pressure (both systolic and diastolic blood pressure) will be recorded in the follow-up form.
Pulse
Time frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's pulse values will be measured on the monitor and the pulse will be recorded in the follow-up form.
Saturation Value
Time frame: 15 minute
Just before the start of the operation and every 15 minutes after the operation, the patient's saturation value will be measured on the monitor and the saturation will be recorded in the follow-up form.
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 2 Feb 2024.
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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.
Yusuf Beşirik, MScN student principal investigator
Bucak State Hospital
Serap Sayar, PhD study director
KTO Karatay University
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 in people with Total Knee Replacement Surgery and Virtual Reality, run by Bucak State Hospital 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 6 inclusion and 3 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 2 Feb 2024. 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?
State Anxiety Scale (time frame: 10 minute). The study lists 5 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 2 Feb 2024.