IntraoperativeNCT07258420
Effect of Watching Video With Virtual Reality Glasses During Surgery on Anxiety and Comfort Levels
A study testing Using a virtual reality glasses in people with Intraoperative and Anxiety, run by Trakya University at 1 site in Turkey (Türkiye).
Trial summary
This study was conducted to evaluate the effect of using virtual reality glasses during surgery on patients' anxiety and comfort levels. The main hypotheses are as follows: H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intraoperative, Anxiety, Comfort
- What is being tested?
- Using a virtual reality glasses
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Sep 2023to 25 Dec 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To research;
- Planned elective surgery
- Those who will undergo inguinal hernia surgery for the first time
- Those who do not have vision, hearing and perception problems
- Patients who want to participate in the study voluntarily were included.
Who cannot join
- Any anesthesia method other than spinal anesthesia was applied during the procedure
- Under the age of 18, over the age of 75
- Having advanced vision and hearing problems
- Diagnosed with mental and psychological illness
- Using anti-depressant/sedative medication
- Having stopped watching videos during the surgical procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Using Virtual Reality Glasses on Patients' Anxiety and Comfort Levels in Open Inguinal Hernia Surgery Performed With Spinal Anesthesia
This study was conducted to evaluate the effect of using virtual reality glasses during surgery on patients' anxiety and comfort levels. The main hypotheses are as follows:
H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than those of patients who do not use them.' H2: It was determined that 'The comfort levels of patients who use virtual reality glasses during open inguinal hernia surgery performed with spinal anesthesia are higher than those of patients who do not use them'.
Participants will be asked to watch a video using VR goggles during surgery. If there is a comparison group: Researchers will compare patients to a control group to see if there are any differences in anxiety and comfort levels.
Read the detailed description
Randomization method will be used to determine the groups. Randomization of the patients was done using 'Random Allocation Software 2.0' program and they were divided into 2 groups: 1) Control group and 2) Intervention group.
- Control Group: Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.
- Intervention Group: Patients in this group will be visited by the researcher in the pre-anesthesia recovery room in the operating room before surgery. Patients will be informed about the virtual reality glasses they will use during surgery. Patients will be asked to watch videos with virtual reality glasses during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess patients' anxiety levels; Perioperative Comfort Scale was used to assess their comfort levels.
- Conditions
- Intraoperative, Anxiety, Comfort
- Being tested
- Using a virtual reality glasses
- Keywords
- comfort, nursing care, virtual reality, surgery anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using a virtual reality glassesOther
Virtual reality glasses were used on the patients in the study group within the scope of the study. G04EA VR Shinecon 3D Virtual Reality Glasses are compatible with 4.0-6.53 inch Android and IOS smart phones. 3D stereo sound unit is with Bluetooth stereo headset. Due to the use of specially designed resin lenses, it will not cause dizziness or visual fatigue even if worn for a long time. It has IMAX giant screen technology with 720° panoramic view. Flexible, adjustable headband is suitable for most head sizes. Adjustable viewing distance provides maximum comfort.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Patients will be visited in the rest room in the operating room before the surgery and will be informed about the virtual reality glasses they will use during the surgery. Patients will be asked to watch videos with virtual reality glasses during the surgery. Visual Analog Scale-A was used to assess the anxiety levels of patients and Perioperative Comfort Scale was used to assess their comfort levels Receives: Other: Using a virtual reality glasses |
| Control group | No intervention | Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels. |
What is being measured
The primary outcome is the main question the study is designed to answer.
anxiety level
The anxiety levels of the patients will be evaluated with the Visual Analog Scale. It is a measurement tool that can be repeated and requires minimal tools, and is a one-dimensional scale frequently used in the measurement of subjective parameters. VAS is used to convert some values that cannot be measured numerically into numerical values. A 100 mm line is scaled with 10 mm intervals, the two end definitions of the parameter to be evaluated are written on both ends of the line, and the patient is asked to indicate where his/her own situation fits on this line by drawing, putting a dot, or pointing. To evaluate anxiety; "I have no anxiety" labels are placed on the zero point on the line divided into 10 cm, and "I feel a lot of anxiety" labels are placed above the 10th cm.
Measured: 18 mounth
Secondary outcomes (1)
comfort level
The comfort level of the patients will be evaluated with the Perianesthesia Comfort Scale. The lowest total score that can be obtained from the scale is 24, and the highest total score is 144. The average value is found by dividing the total score obtained by the number of scale items and the result is expressed in the 1-6 distribution. Low comfort is expressed with one point, high comfort with six points.
Measured: 18 mounth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start27 Sep 2023
- Primary completion27 Sep 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IntraoperativeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will be conducted using randomized controlled, experimental type and single blind research methods. For this purpose, after the data is collected, it will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. The randomization method will be used to determine the groups. For this, patients who meet the study criteria and volunteer will be assigned to the groups according to the order of their surgery using the 'Random Allocation Software 2.0' randomization program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seher Ünver, Trakya University
- Investigators
- Seher Ünver, Assoc. Prof., Principal investigator, Trakya UniversityEsra Çevik, BSN, MSC, Principal investigator, Trakya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258420
- Sponsor's protocol ID
- 2023-PO189
- Status last verified
- Nov 2025
- First submitted
- 20 Nov 2025
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Using Virtual Reality Glasses on Patients' Anxiety and Comfort Levels in Open Inguinal Hernia Surgery Performed With Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07258420
- Acronym / sponsor ID
- 2023-PO189
- Conditions
- Intraoperative, Anxiety, Comfort
- Keywords
- comfort, nursing care, virtual reality, surgery anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Study start
- 27 Sep 2023 (actual)
- Primary completion
- 27 Sep 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 2 Dec 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.
This study was conducted to evaluate the effect of using virtual reality glasses during surgery on patients' anxiety and comfort levels. The main hypotheses are as follows:
H1: 'During open inguinal hernia surgery performed with spinal anesthesia, anxiety levels of patients using virtual reality glasses are lower than those of patients who do not use them.' H2: It was determined that 'The comfort levels of patients who use virtual reality glasses during open inguinal hernia surgery performed with spinal anesthesia are higher than those of patients who do not use them'.
Participants will be asked to watch a video using VR goggles during surgery. If there is a comparison group: Researchers will compare patients to a control group to see if there are any differences in anxiety and comfort levels.
Detailed description
Randomization method will be used to determine the groups. Randomization of the patients was done using 'Random Allocation Software 2.0' program and they were divided into 2 groups: 1) Control group and 2) Intervention group.
- Control Group: Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels.
- Intervention Group: Patients in this group will be visited by the researcher in the pre-anesthesia recovery room in the operating room before surgery. Patients will be informed about the virtual reality glasses they will use during surgery. Patients will be asked to watch videos with virtual reality glasses during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess patients' anxiety levels; Perioperative Comfort Scale was used to assess their comfort levels.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will be conducted using randomized controlled, experimental type and single blind research methods. For this purpose, after the data is collected, it will be coded as A and B groups, so the researcher who will make the research statistics will analyze the data without knowing the study and control groups. The randomization method will be used to determine the groups. For this, patients who meet the study criteria and volunteer will be assigned to the groups according to the order of their surgery using the 'Random Allocation Software 2.0' randomization program.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Using a virtual reality glassesPatients will be visited in the rest room in the operating room before the surgery and will be informed about the virtual reality glasses they will use during the surgery. Patients will be asked to watch videos with virtual reality glasses during the surgery. Visual Analog Scale-A was used to assess the anxiety levels of patients and Perioperative Comfort Scale was used to assess their comfort levels |
| Control group | No intervention | –Patients in this group will be visited by the researcher in the pre-anesthesia listening room in the operating room before surgery. No other intervention will be made to the patients during surgery. Patients will be visited again in the post-anesthesia recovery room after surgery. Visual Analog Scale-A was used to assess the anxiety levels of the patients; Perioperative Comfort Scale was used to assess their comfort levels. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- To research;
- Planned elective surgery
- Those who will undergo inguinal hernia surgery for the first time
- Those who do not have vision, hearing and perception problems
- Patients who want to participate in the study voluntarily were included.
Key exclusion criteria (6 listed)
- Any anesthesia method other than spinal anesthesia was applied during the procedure
- Under the age of 18, over the age of 75
- Having advanced vision and hearing problems
- Diagnosed with mental and psychological illness
- Using anti-depressant/sedative medication
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 |
|---|---|---|
| Using a virtual reality glassesVirtual reality glasses were used on the patients in the study group within the scope of the study. G04EA VR Shinecon 3D Virtual Reality Glasses are compatible with 4.0-6.53 inch Android and IOS smart phones. 3D stereo sound unit is with Bluetooth stereo headset. Due to the use of specially designed resin lenses, it will not cause dizziness or visual fatigue even if worn for a long time. It has IMAX giant screen technology with 720° panoramic view. Flexible, adjustable headband is suitable for most head sizes. Adjustable viewing distance provides maximum comfort. | Other | Intervention group |
Primary outcome
anxiety level
Time frame: 18 mounth
The anxiety levels of the patients will be evaluated with the Visual Analog Scale. It is a measurement tool that can be repeated and requires minimal tools, and is a one-dimensional scale frequently used in the measurement of subjective parameters. VAS is used to convert some values that cannot be measured numerically into numerical values. A 100 mm line is scaled with 10 mm intervals, the two end definitions of the parameter to be evaluated are written on both ends of the line, and the patient is asked to indicate where his/her own situation fits on this line by drawing, putting a dot, or pointing. To evaluate anxiety; "I have no anxiety" labels are placed on the zero point on the line divided into 10 cm, and "I feel a lot of anxiety" labels are placed above the 10th cm.
1 secondary outcome
comfort level
Time frame: 18 mounth
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 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Intraoperative
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
68Ga-XMFH01 PET/Fluorescence Imaging in Prostate Cancer
Prostate Cancer (Diagnosis), ACP3
RecruitingObservational study
AIDE: Decision Support for Anastomosis or Colostomy in Emergency Surgery for Complicated Acute Diverticulitis
Complicated Diverticulitis, Acute Diverticulitis
RecruitingPhase 4
Remimazolam Versus Propofol for Maintenance of Anaesthesia During Major Hepatectomy Under Low Central Venous Pressure
Intraoperative Hypotension, Hepatectomy
Recruiting
4D Duke Microscope Integrated Optical Coherence Tomography in a Zeiss Artevo 800
Corneal Diseases, Retinal Diseases
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.
Seher Ünver, Assoc. Prof. principal investigator
Trakya University
Esra Çevik, BSN, MSC principal investigator
Trakya 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 Using a virtual reality glasses in people with Intraoperative and Anxiety, run by Trakya 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 6 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 Dec 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?
anxiety level (time frame: 18 mounth). 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 Dec 2025.