Effect of Virtual Reality Application on Pain, Anxiety and Comfort During Chest Tube Removal Procedure

August 10, 2024 updated by: Hale Rumeysa Seçer

Göğüs Tüpü Çıkarma İşlemi Sırasında Sanal Gerçeklik Uygulamasının Ağrı, Anksiyete ve Konfora Etkisi

Chest tubes are used to eliminate possible acute or chronic problems that may occur after trauma or surgical interventions to the chest area. This process, which aims to drain the fluid, blood or air accumulated in the pleural area, works with the support of closed underwater drainage systems. The chest tubes, which remain in place for a long time, fuse with the endothelium lying in the chest cavity. For this reason, the adhesions formed with the fusion cause very severe acute pain in the patient with the pulling force applied during removal.The high level of pain of the person will cause an increase in the level of anxiety and a decrease in the level of comfort. The anxiety experienced by the patients will also reduce the tolerance to pain.It has been observed that the use of virtual reality in the field of health significantly reduces the level of pain and anxiety during medical procedures, shortens wound healing and hospital stay, and increases compliance with treatment.In the literature, no studies were found in which the effects of virtual reality application on pain, anxiety and comfort were evaluated in patients whose chest tube was removed.Thereforee, this study was conducted to evaluate the effect of virtual reality application against all these negative situations.

Study Overview

Status

Enrolling by invitation

Conditions

Study Type

Interventional

Enrollment (Estimated)

82

Phase

  • 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

      • Erzurum, Turkey
        • Ataturk University

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

  • Study Inclusion Criteria:

    • Must be between the ages of 18-65,
    • Must have undergone coronary artery bypass graft surgery and have a chest tube,
    • Must participate in the study voluntarily,
    • Must not have vision or hearing problems,
    • Must not have disorientation in place and time,
    • Must not have any psychiatric disorders,
  • Study Exclusion Criteria:

    • Those with chronic pain and routinely using painkillers,
    • Those using painkillers before the procedure,
    • Those with problems such as migraine, vertigo, dizziness,
    • Patients using prescription glasses and those having vision problems without glasses were not included in the study.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group using virtual reality glasses
Virtual reality application will be applied to this group and virtual reality glasses will be put on 5 minutes before the procedure and the video will be started to be watched during the process.
Group using virtual reality glasses: During the procedure, individuals will wear glasses.
No Intervention: Group not using virtual reality glasses
Standard protocols will be applied to this group and no action will be taken.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
visual analog scale
Time Frame: 5 month

To evaluate pain severity, pain results are evaluated by scoring between 0-10. While 0 indicates "No pain", 10 indicates "Unbearable pain".

The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result

5 month
State-Trait Anxiety Inventory Scale
Time Frame: 5 month
It is a 4-point Likert-type scale with 40 items and is scored as "never": 1, "a little": 2, "a lot": 3, "completely": 4, according to the degree of severity of the feelings, thoughts or behaviors expressed by the items. anxiety level will be determined.
5 month
comfort scale
Time Frame: 5 month

It is a scale ranging from 0 to 10 points. While 0 points indicate 'most comfortable', 10 points indicate 'most uncomfortable'.

The minimum value is 0 and the maximum value is 10. 0 represents a good result and 10 represents a bad result

5 month
verbal pain scale
Time Frame: 5 month
0 points indicate "No pain", 1 point indicates "Mild pain", 2 points indicate "Moderate pain" and 3 points indicate "Severe pain".
5 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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)

March 20, 2023

Primary Completion (Actual)

July 25, 2024

Study Completion (Estimated)

August 30, 2024

Study Registration Dates

First Submitted

July 20, 2024

First Submitted That Met QC Criteria

August 10, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2024

Last Update Submitted That Met QC Criteria

August 10, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • VRA15

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.

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