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Active, not recruitingNCT06591832Updated Sep 19, 2024

Effect of Virtual Reality-Based Relaxation Exercise on Postoperative Pain and Kinesiophobia After Total Knee Replacement

An interventional study of Exercise in Randomized Controlled Trial, sponsored by Aksaray University. Active, not recruiting at 2 sites in Turkey. Open to participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by Aksaray University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 10 months ago, but the record still lists the study as active, not recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
40 Years and older
Sex
All
01

Study summary

The aim of this study is to evaluate the effect of virtual reality-based relaxation exercise on pain and kinesiophobia in patients after total knee arthroplasty.

Read the detailed description

Virtual reality application, which is a non-pharmacological application; It is a three-dimensional simulation model that gives individuals the feeling of reality and allows mutual communication with a dynamic environment created by computers, and studies determining the effects of the application are increasing day by day. Virtual reality-based rehabilitation is a promising approach to achieve recovery in many cases, optimize functional outcomes, and increase the clinical and social benefits of surgery . As a result, pain and fear of movement may negatively affect early functional results in patients undergoing total knee arthroplasty. Explaining how to change patients' fears, encouraging them to adopt positive attitudes and increasing their physical strength has an important place in determining the effectiveness of virtual reality application.

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Conditions studied

  • Randomized Controlled Trial

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Keywords

  • Pain
  • kinesiophobia
  • virtual reality glasses
03

In context

Kinesiophobia

243 studies on the registry are indexed under Kinesiophobia; 89 are open to participants now.

This study's planned enrollment of 78 is above the median of 51 across 145 interventional studies indexed under Kinesiophobia.

Browse Kinesiophobia studies →

Lead sponsor

Aksaray University is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • The research included people between the ages of 40-75,
  • Volunteering to participate in the research,
  • Being able to understand and speak Turkish,
  • Being able to understand the verbal, written and video explanations given,
  • Having no problems communicating cognitively, affectively and verbally,
  • Not having any obstacle to using virtual reality glasses,
  • Patients who underwent unilateral TKA surgery,
  • Using the SPH device at the same degree for three postoperative days after the FFP operation.
  • Having the surgeon's permission

Exclusion criteria

Exclusion Criteria:

  • Patients who will undergo revision TDP surgery,
  • Those who have a neurological disease that causes functional disability,
  • Those with a diagnosed psychiatric disorder,
  • Refusing to take the SPH device after the operation or taking it to a different degree,
  • Those who have a condition that prevents them from wearing virtual glasses for any reason,
  • These are patients after the FFP operation and outside the third postoperative day.
05

Study design

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

Study arms

  • Experimental
    Experimental Gorup

    Routine nursing practice will be performed and Virtual reality based progressive relaxation exercise will be applied

    Other: Exercise

  • No intervention
    Control Group

    Routine nursing practice will be performed

Interventions

  • OtherExercise

    Virtual reality based progressive relaxation exercise

06

What researchers measure

Primary outcomes

  1. Visual Analog Scale

    Visual Analog Scale

    Time frame: Min 0 Max 10 (As the score increases, the pain increases.)

  2. Tampa kinesiophobia scale

    assesses fear of movement

    Time frame: min 17 max 68 (As the score increases, the fear of movement increases.)

Secondary outcomes

  1. After application Visual Analog Scale

    Visual Analog Scale

    Time frame: Min 0 Max 10 (As the score increases, the pain increases.)

  2. After application Tampa kinesiophobia scale

    assesses fear of movement

    Time frame: min 17 max 68 (As the score increases, the fear of movement increases.)

07

Study locations

2 sites
  • Aksaray University
    Aksaray, 68100, Turkey
  • Aksaray Universitesi
    Aksaray, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06591832
Lead sponsor
Aksaray University
Responsible party
Zeynep Kocak (Principal Investigator, Aksaray University) — Principal investigator
First posted
Sep 19, 2024
Start date
Jan 15, 2024
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Sep 19, 2024

Study contacts

Zeynep Koçak
principal investigator · Aksaray University
Funda Çetinkaya
principal investigator · Aksaray University

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 active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.

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