Distraction Techniques for Postoperative Pain After Total Knee Arthroplasty: A Randomized Controlled Trial

January 28, 2026 updated by: Berna Dizer, Izmir Tinaztepe University

he Effect of Virtual Reality Headset, Squishy (Squeeze Toy), and Poetry Reading on Postoperative Pain Control After Total Knee Arthroplasty

This randomized controlled trial evaluates the effectiveness of three distraction techniques-virtual reality (VR) headset, squishy (squeeze toy), and poetry reading-on postoperative pain control in adults undergoing total knee arthroplasty. Participants are randomized into four parallel groups (three intervention arms and one usual care control). Pain intensity is assessed using the Visual Analog Scale (VAS), with primary assessment at 24 hours after surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Total knee arthroplasty is a common orthopedic procedure that can be associated with significant postoperative pain. In addition to standard pharmacological analgesia, non-pharmacological approaches such as distraction techniques may help reduce perceived pain by redirecting attention away from nociceptive stimuli. This single-center, parallel-group randomized controlled trial will be conducted in the Orthopedics and Traumatology Clinic of Osmaniye State Hospital in Türkiye. Eligible adults (≥18 years) undergoing total knee arthroplasty will be randomized using a stratified block randomization approach based on baseline pain severity (VAS 0-3, 4-6, 7-10) to ensure balanced allocation across groups. The intervention arms include (1) VR headset distraction, (2) use of a squishy (squeeze toy) as a tactile distraction method, and (3) poetry reading as a cognitive distraction method. The control group receives usual postoperative care without a structured distraction intervention. All groups follow the same postoperative analgesia protocol. The primary outcome is postoperative pain intensity measured by VAS at 24 hours after surgery.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Undergoing total knee arthroplasty
  • Hospitalized in the postoperative period at Osmaniye State Hospital
  • Able to communicate and complete pain assessment (Visual Analog Scale)
  • Provides written informed consent
  • Managed under the same postoperative analgesia protocol and operated by the same surgeon (as per study protocol)

Exclusion Criteria:

  • Severe cognitive impairment or inability to provide valid pain assessment
  • Postoperative complications that may interfere with participation or pain assessment
  • Contraindication to the assigned distraction method (e.g., intolerance to wearing a VR headset, severe nausea/dizziness, claustrophobia)
  • Refusal or withdrawal of consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Virtual Reality (VR) Headset
Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will receive a structured distraction intervention using a virtual reality (VR) headset during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). The VR content is delivered under supervision at the bedside as a non-pharmacological distraction method.
Behavioral: VR Distraction
A supervised virtual reality distraction session delivered via a VR headset during postoperative hospitalization to support non-pharmacological pain management.
Other Names:
  • Virtual Reality (VR) Headset Distraction
Experimental: Squishy (Squeeze Toy)
Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will use a squishy (squeeze toy) as a tactile distraction method during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). Participants are instructed to use the squeeze toy during episodes of pain/discomfort as a non-pharmacological distraction technique.
Behavioral: Tactile Distraction With Squishy
Use of a squishy (squeeze toy) as a tactile distraction technique during postoperative hospitalization as part of non-pharmacological pain management.
Other Names:
  • Squeeze Toy (Squishy) Distraction
Experimental: Poetry Reading
Participants will receive routine postoperative care and standard analgesia according to the hospital protocol. In addition, they will perform poetry reading as a cognitive distraction method during the postoperative pain period while hospitalized (e.g., within the first 24 hours after surgery). Poetry reading is provided as a structured non-pharmacological distraction intervention at the bedside.
Behavioral: Poetry Reading Distraction
Structured poetry reading conducted during postoperative hospitalization as a cognitive distraction approach to support non-pharmacological pain management.
Other Names:
  • Poetry Reading
No Intervention: Usual Care Control
articipants will receive routine postoperative care and standard analgesia according to the hospital protocol. No structured distraction intervention (VR, squishy, or poetry reading) will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (VAS)
Time Frame: 24 hours after surgery
Visual Analog Scale pain score (0=no pain, 10=worst pain).
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity (VAS) by Pain Severity Strata
Time Frame: 24 hours after surgery
VAS pain score analyzed by baseline pain strata (0-3, 4-6, 7-10) using stratified allocation groups.
24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Izmir Tinaztepe University

Investigators

  • Principal Investigator: Songül Gungor, Osmaniye State Hospital
  • Study Director: Berna Dizer, Izmir Tinaztepe University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Actual)

January 10, 2026

Study Completion (Actual)

January 10, 2026

Study Registration Dates

First Submitted

January 22, 2026

First Submitted That Met QC Criteria

January 22, 2026

First Posted (Actual)

January 29, 2026

Study Record Updates

Last Update Posted (Actual)

January 30, 2026

Last Update Submitted That Met QC Criteria

January 28, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • İzmirTınaztepeÜ-B.Dizer-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The informed consent/IRB approval did not include permission for public deposition of individual participant-level data. In accordance with local privacy regulations in Türkiye (e.g., KVKK), individual participant data will not be shared publicly. De-identified and aggregated data may be provided by the corresponding author upon reasonable request under a data-use agreement.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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