Total Knee ArthroplastyNCT07375472
Distraction Techniques for Postoperative Pain After Total Knee Arthroplasty: A Randomized Controlled Trial
A study testing VR Distraction, Tactile Distraction With Squishy and Poetry Reading Distraction in people with Total Knee Arthroplasty and Postoperative Pain, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty, Postoperative Pain
- What is being tested?
- VR Distraction, Tactile Distraction With Squishy and Poetry Reading Distraction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jan 2025to 10 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Being tested
- VR Distraction, Tactile Distraction With Squishy, Poetry Reading Distraction
- Keywords
- virtual reality, distraction technique, postoperative pain, total knee arthroplasty, nursing intervention
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR DistractionBehavioural
Also called Virtual Reality (VR) Headset Distraction
A supervised virtual reality distraction session delivered via a VR headset during postoperative hospitalization to support non-pharmacological pain management.
Tactile Distraction With SquishyBehavioural
Also called Squeeze Toy (Squishy) Distraction
Use of a squishy (squeeze toy) as a tactile distraction technique during postoperative hospitalization as part of non-pharmacological pain management.
Poetry Reading DistractionBehavioural
Also called Poetry Reading
Structured poetry reading conducted during postoperative hospitalization as a cognitive distraction approach to support non-pharmacological pain management.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity (VAS)
Visual Analog Scale pain score (0=no pain, 10=worst pain).
Measured: 24 hours after surgery
Secondary outcomes (1)
Pain Intensity (VAS) by Pain Severity Strata
VAS pain score analyzed by baseline pain strata (0-3, 4-6, 7-10) using stratified allocation groups.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start14 Jan 2025
- Primary completion10 Jan 2026
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Tinaztepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Dizer, Izmir Tinaztepe University
- Investigators
- Songül Gungor, Principal investigator, Osmaniye State HospitalBerna Dizer, Study director, Izmir Tinaztepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375472
- Sponsor's protocol ID
- İzmirTınaztepeÜ-B.Dizer-003
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 30 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effect of Virtual Reality Headset, Squishy (Squeeze Toy), and Poetry Reading on Postoperative Pain Control After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT07375472
- Acronym / sponsor ID
- İzmirTınaztepeÜ-B.Dizer-003
- Conditions
- Total Knee Arthroplasty, Postoperative Pain
- Keywords
- virtual reality, distraction technique, postoperative pain, total knee arthroplasty, nursing intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Izmir Tinaztepe UniversityUniversity, hospital or other
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 10 Jan 2026 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) Headset | Experimental | Behavioral: VR DistractionParticipants 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. |
| Squishy (Squeeze Toy) | Experimental | Behavioral: Tactile Distraction With SquishyParticipants 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. |
| Poetry Reading | Experimental | Behavioral: Poetry Reading DistractionParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR DistractionAlso: Virtual Reality (VR) Headset DistractionA supervised virtual reality distraction session delivered via a VR headset during postoperative hospitalization to support non-pharmacological pain management. | Behavioural | Virtual Reality (VR) Headset |
| Tactile Distraction With SquishyAlso: Squeeze Toy (Squishy) DistractionUse of a squishy (squeeze toy) as a tactile distraction technique during postoperative hospitalization as part of non-pharmacological pain management. | Behavioural | Squishy (Squeeze Toy) |
| Poetry Reading DistractionAlso: Poetry ReadingStructured poetry reading conducted during postoperative hospitalization as a cognitive distraction approach to support non-pharmacological pain management. | Behavioural | Poetry Reading |
Primary outcome
Pain Intensity (VAS)
Time frame: 24 hours after surgery
Visual Analog Scale pain score (0=no pain, 10=worst pain).
1 secondary outcome
Pain Intensity (VAS) by Pain Severity Strata
Time frame: 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songül Gungor principal investigator
Osmaniye State Hospital
Berna Dizer study director
Izmir Tinaztepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR Distraction, Tactile Distraction With Squishy and Poetry Reading Distraction in people with Total Knee Arthroplasty and Postoperative Pain, run by Izmir Tinaztepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Intensity (VAS) (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2026.