Virtual Reality: Distraction During Small Bore Intercostal Chest Drain Insertion

NCT06247800 | Recruiting

• 1 other identifier: FF-2024-002
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Intercostal chest drain (ICC) insertion is a common procedure done worldwide to treat and diagnose pleural disease. It is used to evacuate fluid, blood, or air in the cavity from a myriad of causes namely pleural effusions of different etiologies, empyema, hemothorax, chylothorax and pneumothorax. It also functions as a route for antibiotics, pleurodesis and fibrinolytics. Hippocrates, whose practiced medicine 2,400 years ago, is often credited with being the first to insert a metal tube into the pleural region to drain fluid. It wasn't until the 19th century that a closed drainage system was properly documented in the literature, although open drainage remained to be the norm for quite some time. In the past, large-bore tubes (24-32 F) were recommended in nearly all circumstances and were inserted using a blunt dissection technique. However, during the past two decades, small-bore catheters have become increasingly popular. They were first used to drain abdominal collections and have now been adopted for use in draining the pleural cavity utilizing the needle and guide wire Seldinger procedure, typically with radiological guidance. In addition to that, Seldinger technique allow us to insert the catheter at lower intercostals spaces without injury to the diaphragm or abdominal organs, thereby ensuring patient safety.

Conditions

Pleural Effusion

Outcome Measures

Primary Outcomes (1)

• To compare the satisfaction of participants undergoing intercostal chest drain insertion with or without VR using a 5-point Likert scale satisfaction questionnaire (1 - very dissatisfied, 2-dissatisfied, 3-neutral, 4-satisfied, 5-very satisfied).

  Participants who underwent intercostal chest drain insertion with and without VR device will be assess with 5 point Likert Scale for satisfaction score.

  30 minutes after procedure

Secondary Outcomes (9)

• To assess tolerability (pain, and breathlessness) of participants undergoing ICC with or without VR, using a 10 cm Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level) before ICC insertion

  10 minutes before procedure

• To assess tolerability (pain, and breathlessness) of participants undergoing ICC with or without VR, using a 10 cm Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level) after ICC insertion

  30 minutes after procedure

• To assess the anxiety of participants undergoing ICC with or without VR using the State-Trait-Anxiety-Inventory (STAI) score before ICC insertion (minimum score of 20 to maximum score of 80)

  10 minutes before procedure

• To assess the anxiety of participants undergoing ICC with or without VR using the State-Trait-Anxiety-Inventory (STAI) score after ICC insertion (minimum score of 20 to maximum score of 80)

  30 minutes before procedure

• To assess satisfaction of proceduralist's performing ICC insertion with or without VR using satisfaction questionnaire (5-point Likert scale). (1 - very dissatisfied, 2-dissatisfied, 3-neutral, 4-satisfied, 5-very satisfied).

  30 minutes after procedure

Study Arms (2)

Patient undergoing chest drain with the use of VR device

ACTIVE COMPARATOR

Patient undergoing chest drain with the use of VR device on, for those on VR device, they will be shown a video consisting of calming nature scene together with soothing instrumental music.

Device: Virtual Reality Device

Patient undergoing chest drain without the use of VR device

ACTIVE COMPARATOR

Patient undergoing chest drain without the use of VR device on, as per standard practise

Other: Without virtual reality

Interventions

Virtual Reality Device DEVICE

A virtual reality headset is a heads-up display that allows users to interact with simulated environment.

Patient undergoing chest drain with the use of VR device

Without virtual reality OTHER

Patients undergoing intercostal chest drain without the use VR device

Patient undergoing chest drain without the use of VR device

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants undergoing ICC insertion
• Participants who could understand and give consent

You may not qualify if:

• Participants who are unable to understand or give consent
• Ventilated patients
• Participants who are not comfortable wearing VR device
• Participants who are unable to communicate (illiterate, had hearing impairment, mute, blind or had memory impairment)
• Participants with craniofacial deformity
• Participants who are on sedative medication
• Traumatic or post Motor Vehicular Accident patient Participants undergoing Indwelling pleural catheter insertion Participants with anxiety disorder

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (1)

National University of Malaysia

Kuala Lumpur, Kuala Lumpur, 56000, Malaysia

RECRUITING

MeSH Terms

Conditions

Pleural Effusion

Condition Hierarchy (Ancestors)

Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Mohamed Faisal Abdul Hamid, MBBS (IIUM)

  National University of Malaysia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Faisal Abdul Hamid, MBBS (IIUM)

CONTACT

0391455555; faisal.hamid@ppukm.ukm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 8, 2024
• Study Start: February 1, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)