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NCT Number: NCT07258420

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

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.

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Key information

Conditions

Intraoperative Anxiety Anxiety Disorders Comfort Mental Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Trakya University

Edirne, Merkez, 22030, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. comfort level

    Time frame: 18 mounth

    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.

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Registry information

Official study title

The Effect of Using Virtual Reality Glasses on Patients' Anxiety and Comfort Levels in Open Inguinal Hernia Surgery Performed With Spinal Anesthesia

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 2, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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