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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Izmir Tinaztepe University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 14, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 22, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 30, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Postoperative Pain

Clinical Trials on VR Distraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings