NCT06550323

Brief Summary

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.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Study Start

First participant enrolled

March 20, 2023

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

July 20, 2024

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

1.4 years

First QC Date

July 20, 2024

Last Update Submit

August 10, 2024

Conditions

Keywords

virtual realitypainanxietycomfort

Outcome Measures

Primary Outcomes (4)

  • visual analog scale

    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

    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

    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

    0 points indicate "No pain", 1 point indicates "Mild pain", 2 points indicate "Moderate pain" and 3 points indicate "Severe pain".

    5 month

Study Arms (2)

Group using virtual reality glasses

EXPERIMENTAL

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.

Device: Group using virtual reality glasses

Group not using virtual reality glasses

NO INTERVENTION

Standard protocols will be applied to this group and no action will be taken.

Interventions

Group using virtual reality glasses: During the procedure, individuals will wear glasses.

Group using virtual reality glasses

Eligibility Criteria

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

You may qualify if:

  • 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,

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University

Erzurum, Turkey (Türkiye)

Location

Related Publications (1)

  • Secer H, Yayla A. The effects of virtual reality on pain, anxiety, and comfort during the chest tube removal procedure: A randomized clinical trial. Complement Ther Clin Pract. 2025 Feb;58:101931. doi: 10.1016/j.ctcp.2024.101931. Epub 2024 Nov 8.

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Nurse

Study Record Dates

First Submitted

July 20, 2024

First Posted

August 13, 2024

Study Start

March 20, 2023

Primary Completion

July 25, 2024

Study Completion

August 30, 2024

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations