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OpenTrials
Completed

NCT Number: NCT07065084

The Effect of Virtual Reality Application on Pain, Anxiety, Vital Signs on Hernia Patients Operated With Spinal Anesthesia

Abstract The aim of this study was to evaluate the effect of virtual reality application on pain, anxiety and vital signs during the procedure. This randomized controlled study included 110 hernia patients who underwent spinal anesthesia in the General Surgery Operating Room of a hospital in the western region of Turkey. Patients were randomly assigned to the experimental group or the control group. Patients in the experimental group (n=55) were shown virtual reality goggles and a music-enhanced video for 20 minutes during the surgical procedure. Patients in the control group (n=55) received standard nursing care. Patients in both groups were evaluated using VAS, State and Trait Anxiety Inventory, and Life Findings Monitoring Form.

Keywords: Virtual Reality simulation, Anxiety, Surgery, Pain, Nursing Care

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Manisa Celal Bayar University

Manisa, YUNUSEMRE, 45030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

diagnosed with hernia spinal anesthesia used

Exclusion criteria

psychiatric/mental illness vision/hearing disability general anesthesia used

Treatment and study plan

Virtual Reality glasses

Procedure

In the study, the patients in the intervention group were fitted with VR goggles by the researcher immediately after the spinal anesthesia was administered by the researcher during the operation in hernia patients who received spinal anesthesia for the study, when the patient was placed on the operating table and given the operating position, just before the surgical incision started. The procedures were performed without interfering with anesthesia and general operating room functioning. When the surgical incision was to be made, videos were started to be watched from the VR glasses simultaneously. During the 20 minute procedure, the licensed product "Relax with Nature" with music background with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel screen resolution display unit, China) was watched with virtual reality application. Patients were shown videos of lakes, forests, waterfalls, rivers and beaches. In the studies, it was stated that these videos

Primary outcomes

  1. pain level

    Time frame: preoperative and intraoperative: Two time

    Patients' pain intensity was assessed intraoperatively and postoperatively using the Numerical Rating Scale (NRS). Scale scores range from 0-10.

    A high score indicates an increase in the patient's pain.

Secondary outcomes

  1. Anxiety Level

    Time frame: preoperative and intraoperative: two times

    Anxiety scores of the patients before and after surgery were determined using the 'State-Trait Anxiety Inventory' prepared by Spielberger et al.

    The total score of the scale ranges between 20-80. A total score above 60 indicates severe anxiety. a high score on the scale in the study indicates that the patient's anxiety during and after the procedure is elevated.

Sponsors and collaborators

Lead sponsor

Manisa Celal Bayar University

Other

Registry information

Official study title

The Effect of Virtual Reality Application on Pain, Anxiety and Vital Signs During the Procedure in Hernia Patients Operated With Spinal Anesthesia

Important dates

Study start
2021
Primary completion
2021
Study completion
2023
First posted
Jul 15, 2025
Registry last updated
Jul 17, 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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