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OpenTrials
Completed

NCT Number: NCT07758361

The Effect of Virtual Reality Goggles on Pain, Anxiety and Sleep in Patients Undergoing Total Knee Arthroplasty

Knee osteoarthritis, which occurs after degeneration of the knee joint with age, is common in women after 65 years of age and surgical methods are generally used in the treatment of deformity, pain and limitation of movement. This surgical procedure is different from other surgical procedures.

It takes a long time to perform activities of daily living and return to quality life. At the same time, pain, anxiety and sleep disorders are among the most common problems in the postoperative period. In addition to pharmacological methods, non-pharmacological methods (listening to music, watching movies, daydreaming, humor, virtual reality application, laughter) are used to reduce these problems. In recent years, especially virtual reality application has started to be used as a distraction-based approach in recent years. Virtual reality is the artificial creation of a three-dimensional environment through computer technology. In this application, it is ensured that the individual feels that he/she is a part of the created virtual environment with immersive environments that seem effective. This study was planned to determine the effect of virtual reality glasses on pain, anxiety and sleep in patients undergoing total knee arthroplasty. The study will be conducted with participants who are willing to participate in the study and whose consent has been obtained.

One group will receive virtual reality goggles (experiment) and the other group will receive standard care.

Control group

They will be asked to evaluate their level of "Anxiety and Pain" before and two days after Total Knee Arthroplasty surgery and their level of Sleep at their convenience after waking up the next day.

Experimental group

In addition to the standard care and practices applied to the participants in the control group, you will be asked to watch videos of relaxing nature scenes wearing "Virtual Reality Goggles". These videos last 30 minutes. You will be asked to fill in the same scales for two days preoperatively and two days postoperatively as the participants in the control group.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istinye University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

About this study

For Patient Registries: Also describe the applicable registry procedures and other quality factors (for example, third party certification, on-site audit). In particular, summarize any procedures implemented as part of the patient registry, including, but not limited to the following:

Quality assurance plan that addresses data validation and registry procedures, including any plans for site monitoring and auditing.

Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.

Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (for example, medical records, paper or electronic case report forms, or interactive voice response systems).

Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information if used (for example, World Health Organization Drug Dictionary, MedDRA), and normal ranges if relevant.

Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.

Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.

Plan for missing data to address situations where variables are reported as missing, unavailable, non-reported, uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • underwent elective primary total knee arthroplasty for knee osteoarthritis; (3) were able to communicate in Turkish; (4) were mobilized on the first postoperative day according to the hospital's standard postoperative care protocol; (5) reported a postoperative pain score of ≥4 on the Numeric Rating Scale; and (6) provided written informed consent.

Exclusion criteria

Patients were excluded if they experienced postoperative complications (e.g., severe bleeding, persistent nausea, or vomiting), had cognitive or sensory impairment, psychiatric disorders, communication difficulties, a history of vertigo, uncontrolled hypertension, or were receiving sedative or anxiolytic medications. Participants who did not meet the eligibility criteria were excluded from the study.

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Treatment and study plan

Virtual reality group

Device

Participants received standard postoperative care plus a nurse-guided virtual reality intervention.

Primary outcomes

  1. Postoperative pain intensity measured by the Numeric Rating Scale (NRS)

    Time frame: Immediately before and immediately after each VR session on postoperative day 1 and postoperative day 2

    Pain intensity will be assessed using the 0-10 Numeric Rating Scale (NRS), with higher scores indicating greater pain.

Sponsors and collaborators

Lead sponsor

Sennur Kula Şahin

Other

Registry information

Official study title

It Was Planned as a Single-blind Randomized Controlled Study to Determine the Effect of Virtual Reality Goggles on Pain, Anxiety and Sleep in Patients Undergoing Total Knee Arthroplasty.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

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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