Pleural EffusionVR-STICHNCT06247800
Virtual Reality for Satisfaction and Tolerability During Intercostal Chest Drain Insertion: A Headset-Based Randomized Controlled Trial
A study testing Virtual Reality Device and Without virtual reality in people with Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Virtual Reality Device and Without virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Feb 2024to 9 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All participants undergoing ICC insertion
- Participants who could understand and give consent
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
National University of Malaysia
Kuala Lumpur, Kuala Lumpur, 56000
About this study
Official title: Satisfaction and Tolerability of Virtual Reality as a Distraction During Small-Bore Intercostal Chest Drain Insertion: The VR-STICH Randomized Controlled 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.
Read the detailed description
Research Questions Can Virtual Reality serve as a diversion and improve participant's satisfaction and tolerability during the insertion of a small-bore intercostal chest drain?
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center, prospective, interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. All participants involved in the study will be randomized by 4 block randomizations into either interventional group (VR) or control group (without VR). All participants will be undergoing small bore ICC drain on top of standard care during procedure.
Demographic data was collected prior to randomization, which included (age, gender, ethnicity, BMI, comorbidities) and indications for ICC. The investigator then randomized into 2 groups via block randomization into intervention (VR) and controlled group (without VR).
Subsequently, consent will be obtained from those who are agree to participate, either from the participant him/herself or their next-of-kin. The process of briefing and obtaining consent will be only done once the participant is stable. These processes will not in any way interfering with clinical evaluation, investigation, treatment and intervention done to the participant by the attending doctor. All of the consented participants will be undergoing ICC insertion.
Prior to the ICC insertion, vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness. This is done to determine the participant's baseline score pre-procedure. The pain score was measured by the use of validated 10 cm VAS, a 10 cm line anchored with "no pain" at 0 cm and "unbearable pain" at 10 cm. The breathlessness VAS was measured with a similar scale which was anchored with "no breathlessness" at 0 cm, and "worst possible breathlessness" at 10 cm. Participants will also be given State-Trait-Anxiety-Inventory (STAI) questionnaire. It comprised of twenty statements that assess how respondents feel "at the present time.". They were instructed to circle the number that describes the intensity of their feelings concerning each question best: 1, "not at all;" 2, "somewhat;" 3, "moderately so;" 4, "very much so.". The STAI has a potential score range spanning from 20 to 80, and our study employed both English and a verified translated version in Malay for the questionnaire.
After completing the questionnaires, participants in the interventional group will be given the virtual reality (VR) device to wear, which was the Oculus Quest 2 (Oculus, China) before ICC insertion. The device is owned by respiratory unit HCTM and had been utilized in previous study. Videos of natural scenery were played for them while calming instrumental music played in the background. Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers. The participants were given ten minutes of screening time prior to performing ICC, and after ICC insertion was complete, the device was withdrawn. The VR device was sanitized before and after each use, and participants were given disposable hygiene covers to prevent the risk of pathogen transmission.
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion. ICC insertion will be performed by 2 proceduralist with a 2-year experience in performing ICC and had inserted at least 50 ICC. Post-procedure, VAS questionnaires will be given to participant (on pain and breathlessness), STAI questionnaire on anxiety and satisfaction questionnaire (Likert's scale). These will be completed by the participants at 30 min post procedure. Vital signs of participant will also be taken and recorded post procedure. The proceduralist will be given satisfaction questionnaire upon completion of procedure
- Conditions
- Pleural Effusion
- Being tested
- Virtual Reality Device, Without virtual reality
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality DeviceDevice
A virtual reality headset is a heads-up display that allows users to interact with simulated environment.
Without virtual realityOther
Patients undergoing intercostal chest drain without the use VR device
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Without virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with VAS Score to assess tolerability
Measured: 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
Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with VAS Score to assess tolerability
Measured: 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)
Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with STAI Score to assess anxiety
Measured: 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)
Participants undergoing intercostal chest drain insertion with and without VR device will be assessed with STAI Score to assess anxiety
Measured: 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).
Procedurist will be given 5-point Likert Scale to assess satisfaction in performing intercostal chest drain device
Measured: 30 minutes after procedure
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
Measured: 5 minute before procedure
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
Measured: 5 minute after procedure
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
Measured: 5 minute before procedure
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
Measured: 5 minute after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start1 Feb 2024
- Primary completion9 Sep 2026
- Study completion9 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed Faisal Abdul Hamid, MBBS (IIUM), Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247800
- Sponsor's protocol ID
- FF-2024-002
- Acronym
- VR-STICH
- Status last verified
- Sep 2026
- First submitted
- 15 Jan 2024
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction and Tolerability of Virtual Reality as a Distraction During Small-Bore Intercostal Chest Drain Insertion: The VR-STICH Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06247800
- Acronym / sponsor ID
- VR-STICH / FF-2024-002
- Conditions
- Pleural Effusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 9 Sep 2026 (actual)
- Study completion
- 9 Sep 2026 (actual)
- First posted
- 8 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Questions Can Virtual Reality serve as a diversion and improve participant's satisfaction and tolerability during the insertion of a small-bore intercostal chest drain?
Hypothesis VR leads to better satisfaction of participant during ICC insertion VR reduce pain and anxiety during ICC insertion VR leads to better satisfaction of proceduralist during ICC insertion
Type of Study This is a single center, prospective, interventional study of in-patient participants who are diagnosed with pleural disease and under follow up Respiratory Unit Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia. All participants involved in the study will be randomized by 4 block randomizations into either interventional group (VR) or control group (without VR). All participants will be undergoing small bore ICC drain on top of standard care during procedure.
Demographic data was collected prior to randomization, which included (age, gender, ethnicity, BMI, comorbidities) and indications for ICC. The investigator then randomized into 2 groups via block randomization into intervention (VR) and controlled group (without VR).
Subsequently, consent will be obtained from those who are agree to participate, either from the participant him/herself or their next-of-kin. The process of briefing and obtaining consent will be only done once the participant is stable. These processes will not in any way interfering with clinical evaluation, investigation, treatment and intervention done to the participant by the attending doctor. All of the consented participants will be undergoing ICC insertion.
Prior to the ICC insertion, vital signs will be recorded and both groups will be given a VAS questionnaire to assess their pain and breathlessness. This is done to determine the participant's baseline score pre-procedure. The pain score was measured by the use of validated 10 cm VAS, a 10 cm line anchored with "no pain" at 0 cm and "unbearable pain" at 10 cm. The breathlessness VAS was measured with a similar scale which was anchored with "no breathlessness" at 0 cm, and "worst possible breathlessness" at 10 cm. Participants will also be given State-Trait-Anxiety-Inventory (STAI) questionnaire. It comprised of twenty statements that assess how respondents feel "at the present time.". They were instructed to circle the number that describes the intensity of their feelings concerning each question best: 1, "not at all;" 2, "somewhat;" 3, "moderately so;" 4, "very much so.". The STAI has a potential score range spanning from 20 to 80, and our study employed both English and a verified translated version in Malay for the questionnaire.
After completing the questionnaires, participants in the interventional group will be given the virtual reality (VR) device to wear, which was the Oculus Quest 2 (Oculus, China) before ICC insertion. The device is owned by respiratory unit HCTM and had been utilized in previous study. Videos of natural scenery were played for them while calming instrumental music played in the background. Three-dimensional footage of natural landscapes from across the world was played as participants listened to instrumental music through surround sound speakers. The participants were given ten minutes of screening time prior to performing ICC, and after ICC insertion was complete, the device was withdrawn. The VR device was sanitized before and after each use, and participants were given disposable hygiene covers to prevent the risk of pathogen transmission.
Local anaesthesia will be given as to the participants prior to the procedure at the site of insertion. ICC insertion will be performed by 2 proceduralist with a 2-year experience in performing ICC and had inserted at least 50 ICC. Post-procedure, VAS questionnaires will be given to participant (on pain and breathlessness), STAI questionnaire on anxiety and satisfaction questionnaire (Likert's scale). These will be completed by the participants at 30 min post procedure. Vital signs of participant will also be taken and recorded post procedure. The proceduralist will be given satisfaction questionnaire upon completion of procedure
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing chest drain with the use of VR device | Active comparator | Device: Virtual Reality DevicePatient 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. |
| Patient undergoing chest drain without the use of VR device | Active comparator | Other: Without virtual realityPatient undergoing chest drain without the use of VR device on, as per standard practise |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All participants undergoing ICC insertion
- Participants who could understand and give consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality DeviceA virtual reality headset is a heads-up display that allows users to interact with simulated environment. | Device | Patient undergoing chest drain with the use of VR device |
| Without virtual realityPatients undergoing intercostal chest drain without the use VR device | Other | Patient undergoing chest drain without the use of VR device |
Primary outcome
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).
Time frame: 30 minutes after procedure
Participants who underwent intercostal chest drain insertion with and without VR device will be assess with 5 point Likert Scale for satisfaction score.
9 secondary outcomes
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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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).
Time frame: 30 minutes after procedure
To assess Systolic and Diastolic Blood pressure (in mmHg) , of participants undergoing ICC with and without VR at before ICC insertion
Time frame: 5 minute before procedure
To assess Systolic and Diastolic Blood pressure (in mmHg) , of participants undergoing ICC insertion with and without VR after ICC insertion
Time frame: 5 minute after procedure
To assess Heart rate (rates/minute) of participants undergoing ICC insertion with and without VR at before ICC insertion
Time frame: 5 minute before procedure
To assess Heart rate (rates/minute) of participants undergoing ICC insertion with and without VR after ICC insertion
Time frame: 5 minute after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Faisal Abdul Hamid, MBBS (IIUM) principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Device and Without virtual reality in people with Pleural Effusion, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). (time frame: 30 minutes after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.