Effect of Watching Video With Virtual Reality Glasses During Surgery on Anxiety and Comfort Levels

NCT07258420 | Completed DMC

• 1 other identifier: 2023-PO189
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Intraoperative; Anxiety; Comfort

Keywords

comfort; nursing care; virtual reality; surgery anxiety

Outcome Measures

Primary Outcomes (1)

• 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.

  18 mounth

Secondary Outcomes (1)

• comfort level

  18 mounth

Study Arms (2)

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

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.

Interventions

Using a virtual reality glasses OTHER

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Trakya University: lead

Study Sites (1)

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Seher Ünver, Assoc. Prof.

  Trakya University

  PRINCIPAL INVESTIGATOR

• Esra Çevik, BSN, MSC

  Trakya University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The data analyse is going to be completed by a independent researcher.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assos Prof

Model Details: 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.

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 2, 2025
• Study Start: September 27, 2023
• Primary Completion: September 27, 2024
• Study Completion: December 25, 2024
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)