NCT07375472

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 14, 2025

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2026

Completed
Last Updated

January 30, 2026

Status Verified

January 1, 2026

Enrollment Period

12 months

First QC Date

January 22, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

virtual realitydistraction techniquepostoperative paintotal knee arthroplastynursing intervention

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity (VAS)

    Visual Analog Scale pain score (0=no pain, 10=worst pain).

    24 hours after surgery

Secondary Outcomes (1)

  • Pain Intensity (VAS) by Pain Severity Strata

    24 hours after surgery

Study Arms (4)

Virtual Reality (VR) Headset

EXPERIMENTAL

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

Squishy (Squeeze Toy)

EXPERIMENTAL

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

Poetry Reading

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

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.

Interventions

VR DistractionBEHAVIORAL

A supervised virtual reality distraction session delivered via a VR headset during postoperative hospitalization to support non-pharmacological pain management.

Also known as: Virtual Reality (VR) Headset Distraction
Virtual Reality (VR) Headset

Use of a squishy (squeeze toy) as a tactile distraction technique during postoperative hospitalization as part of non-pharmacological pain management.

Also known as: Squeeze Toy (Squishy) Distraction
Squishy (Squeeze Toy)

Structured poetry reading conducted during postoperative hospitalization as a cognitive distraction approach to support non-pharmacological pain management.

Also known as: Poetry Reading
Poetry Reading

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Osmaniye State Hospital

Osmaniye, 80000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Songül Gungor

    Osmaniye State Hospital

    PRINCIPAL INVESTIGATOR
  • Berna Dizer

    Izmir Tinaztepe University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 22, 2026

First Posted

January 29, 2026

Study Start

January 14, 2025

Primary Completion

January 10, 2026

Study Completion

January 10, 2026

Last Updated

January 30, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

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.

Locations