Virtual Reality: Distraction During Small Bore Intercostal Chest Drain Insertion

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorNational University of Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All participants undergoing ICC insertion

Participants who could understand and give consent

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual Reality Device

    Device

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

  • Without virtual reality

    Other intervention

    Patients undergoing intercostal chest drain without the use VR device

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Patient undergoing chest drain with the use of VR deviceActive comparator 1 intervention
Group B: Patient undergoing chest drain without the use of VR deviceActive comparator 1 intervention

Trial outcomes

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.

Time frame
30 minutes after procedure

Secondary outcomes

1

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

Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with VAS Score to assess tolerability

Time frame
10 minutes before procedure
2

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

Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with VAS Score to assess tolerability

Time frame
30 minutes after procedure
3

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)

Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with STAI Score to assess anxiety

Time frame
10 minutes before procedure
4

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)

Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with STAI Score to assess anxiety

Time frame
30 minutes before procedure

Other outcomes

Sponsors and contacts

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