Pleural Effusion Clinical Trial
— VR-STICHOfficial title:
Virtual Reality: Satisfaction and Tolerability as a Distraction During Small Bore Intercostal Chest Drain Insertion an Open Label Randomized Control 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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | December 25, 2026 |
Est. primary completion date | December 25, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - All participants undergoing ICC insertion - Participants who could understand and give consent Exclusion Criteria - 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 Exclusion Criteria: - |
Country | Name | City | State |
---|---|---|---|
Malaysia | National University of Malaysia | Kuala Lumpur | Wilayah Persekutuan |
Lead Sponsor | Collaborator |
---|---|
National University of Malaysia |
Malaysia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 10 minutes before procedure | |
Secondary | 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 | 30 minutes after procedure | |
Secondary | 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 | 10 minutes before procedure | |
Secondary | 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 | 30 minutes before procedure | |
Secondary | 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). | Procedurist will be given 5-point Likert Scale to assess satisfaction in performing intercostal chest drain device | 30 minutes after procedure | |
Secondary | To assess Systolic and Diastolic Blood pressure (in mmHg) , of participants undergoing ICC with and without VR at before ICC insertion | Participants' vital sign will be assessed at baseline before ICC insertion | 5 minute before procedure | |
Secondary | To assess Systolic and Diastolic Blood pressure (in mmHg) , of participants undergoing ICC insertion with and without VR after ICC insertion | Participants' vital sign will be assessed after ICC insertion | 5 minute after procedure | |
Secondary | To assess Heart rate (rates/minute) of participants undergoing ICC insertion with and without VR at before ICC insertion | Participants' vital sign will be assessed at baseline before ICC insertion | 5 minute before procedure | |
Secondary | To assess Heart rate (rates/minute) of participants undergoing ICC insertion with and without VR after ICC insertion | Participants' vital sign will be assessed after ICC insertion | 5 minute after procedure |
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