NCT06591832

Brief 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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
78

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2024

Completed
7 days until next milestone

Study Start

First participant enrolled

January 15, 2024

Completed
8 months until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

September 19, 2024

Status Verified

January 1, 2024

Enrollment Period

11 months

First QC Date

January 8, 2024

Last Update Submit

September 9, 2024

Conditions

Keywords

Painkinesiophobiavirtual reality glasses

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    Visual Analog Scale

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

  • Tampa kinesiophobia scale

    assesses fear of movement

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

Secondary Outcomes (2)

  • After application Visual Analog Scale

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

  • After application Tampa kinesiophobia scale

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

Study Arms (2)

Experimental Gorup

EXPERIMENTAL

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

Other: Exercise

Control Group

NO INTERVENTION

Routine nursing practice will be performed

Interventions

Virtual reality based progressive relaxation exercise

Experimental Gorup

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Aksaray University

Aksaray, 68100, Turkey (Türkiye)

Location

Aksaray Universitesi

Aksaray, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainKinesiophobia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPhobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Zeynep Koçak

    Aksaray University

    PRINCIPAL INVESTIGATOR
  • Funda Çetinkaya

    Aksaray University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2024

First Posted

September 19, 2024

Study Start

January 15, 2024

Primary Completion

November 30, 2024

Study Completion

December 31, 2024

Last Updated

September 19, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations