ClinicalTrials.gg
CompletedNCT07758361Updated Nov 9, 2026

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

An interventional study of Virtual Reality Group in Arthropathy of Knee, sponsored by Sennur Kula Şahin. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-09.

Sponsored by Sennur Kula Şahin · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 2 years 7 months after the study started (first participant enrolled Jan 2024, registered Aug 2026).

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Phase
Not applicable
Study type
Interventional
Enrollment
94
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

Read the detailed description

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

02

Conditions studied

  • Arthropathy of Knee
03

In context

Lead sponsor

Sennur Kula Şahin is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing elective primary total knee arthroplasty due to knee osteoarthritis
  • Patients able to communicate in Turkish
  • Patients mobilized on the first postoperative day according to the hospital's standard postoperative care protocol
  • Patients with a postoperative pain score ≥4 on the Numerical Rating Scale
  • Patients providing written

Exclusion criteria

Exclusion Criteria:

  • Patients experiencing postoperative complications (e.g., severe bleeding, persistent nausea or vomiting),
  • Cognitive or sensory impairment,
  • Psychiatric disorders, communication difficulties, history of dizziness, uncontrolled hypertension, or patients using sedative or anxiolytic drugs were excluded from the study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
94 participants (actual)

Study arms

  • Experimental
    Virtual Reality Group

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

    Device: Virtual Reality Group

  • No intervention
    Control Group

    Participants received standard postoperative care according to the orthopaedic clinic protocol.

Interventions

  • DeviceVirtual Reality Group

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

06

What researchers measure

Primary outcomes

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

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

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

07

Study locations

1 site
  • Istinye University
    Istanbul, Zeytinburnu 34010, Turkey (Türkiye)
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2024 to primary completion in Mar 2024, 2 months.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Aug 11, 2026
StartActual
Jan 5, 2024
Primary completionActual
Mar 30, 2024
CompletionActual
Dec 30, 2024
Last update
Nov 9, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 9, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07758361
Lead sponsor
Sennur Kula Şahin
Responsible party
Sennur Kula Şahin (Assist Prof, Istinye University) — Sponsor-investigator
First posted
Aug 11, 2026
Start date
Jan 5, 2024
Primary completion
Mar 30, 2024
Completion
Dec 30, 2024
Last update
Nov 9, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

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