Flexible BronchoscopyNCT05340907
Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy
A study testing Virtual Reality Device in people with Flexible Bronchoscopy, run by National University of Malaysia at 3 sites in Malaysia.
Trial summary
Flexible bronchoscopy is an important procedure used worldwide in the diagnosis and treatment of the disease of the of the lungs and airways . Flexible bronchoscopy is an invasive procedure that is utilized to visualize the nasal passages, pharynx, larynx, vocal cords, and tracheal bronchial tree. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Flexible Bronchoscopy
- What is being tested?
- Virtual Reality Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesMalaysia
- Study dates
- 1 May 2022to 31 Aug 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old and above
- Patient undergoing flexible bronchoscopy.
- understand and able to give consent (understand English and Malay)
- patient will need a negative covid PCR test as per standard practic
Who cannot join
- Age < 18
- Unable to understand and give consent (does not understand English, Malay)
- Ventilated patient
- Patient who are not comfortable wearing VR device
- Patient who are unable to communicate (illiterate, hearing impairment, mute, blind, Memory impairment)
- Patient on other sedation other than midazolam/fentanyl
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- Patient undergoing other invasive examination planned alongside bronchoscopy.
- Patient with earlier history of bronchoscopy
- Patient with cranial-facial deformity
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites
University Kebangsaan Malaysia Medical Center
Bandar Tun Razak, Cheras, 56000
National University of Malaysia
Cheras, Kuala Lumpur, 50600
University Kebangsaan Malaysia Medical Centre
Cheras, Kuala Lumpur, 56000
About this study
Official title: Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy in University Kebangsaan Malaysia Medical Centre (UKMMC).
Flexible bronchoscopy is an important procedure used worldwide in the diagnosis and treatment of the disease of the of the lungs and airways . Flexible bronchoscopy is an invasive procedure that is utilized to visualize the nasal passages, pharynx, larynx, vocal cords, and tracheal bronchial tree. It is utilized for both the diagnosis and treatment of lung disorders. The procedure may be performed in an endoscopy suite, the operating room, the emergency department, a radiology suite, or at the bedside in the ICU. Flexible bronchoscopy (FB) is a safe procedure widely used in the management of patients with respiratory diseases. FB has close to zero mortality, and major complications are also very rare. Besides being safe and accurate, the comfort of the patient during the procedure is of primary concern of the medical and endoscopy staff.
Flexible Bronchoscopy can be a frightening and painful experience for the patient. There is room to improve the management of pain during FB, as many patients experience pain despite the common use of premedication analgesics and sedatives. In addition, because.
these medications have side effects, including respiratory depression and cardiovascular instability, it would be useful to develop nonpharmacologic approaches to improving the patient experience with painful procedures. The use of less medication may speed recovery from the procedure and facilitate the timely discharge of patients from the hospital. Nonpharmacologic practices, such as guided imagery, hypnosis, and distraction, have been effective in improving patient experiences during stressful or painful medical procedures. Distraction therapy is a technique in which sensory stimuli are provided to patients in order to divert their attention from an unpleasant experience. The use of nature scenes and sounds is an effective tool for distraction and has been successful in a variety of patient settings, including perioperative care, phlebotomy, and burn care. The benefit of nonpharmacologic approaches to analgesia during FB, however, has not been evaluated adequately. A visual reality (VR) device is an apparatus with a head up display (HUD) that projects a video and contains sound, the device is aimed to replace the patient's natural environment with virtual reality content. The use of Virtual reality(VR) device during flexible bronchoscopy has not been studies before.
Read the detailed description
PROBLEM STATEMENT In Malaysia, flexible bronchoscopy has been well established in many respiratory centers as a means of diagnosis and treatment for many respiratory diseases, however there not many studies into use of nonpharmacological methods of improving patients experience during bronchoscopy. The use of conventional analgesia and sedation is considered standard of care during flexible bronchoscopy. In Respiratory centers, and our own center, Pusat Perubatan UKM (PPUKM), bronchoscopists use fentanyl and midazolam routinely as a means of analgesia during flexible bronchoscopy. There has not been research into the use of Virtual reality (VR) as a method of distraction to reduce anxiety and improve satisfaction in patient undergoing bronchoscopy. Investigators aim to carry out a randomize control trial, to study and compare the use Virtual Reality (VR) device in subjects undergoing flexible bronchoscopy. There are many parameters which the investigators will be looking into, the first will be overall subject's satisfaction with bronchoscope. Investigators will also compare parameter such as anxiety levels during the procedure, pain, cough and also breathlessness.
RESEARCH QUESTION Can VR (Virtual reality) device be used to improve satisfaction, reduce anxiety, pain cough and breathlessness for patients undergoing flexible bronchoscopy
HYPOTHESIS VR device can improve patient's satisfaction of flexible bronchoscopy by using methods of distraction.
VR device can reduce patient's anxiety during flexible bronchoscopy. VR device can reduce patient's pain during flexible bronchoscopy. VR device can reduce patient's cough during flexible bronchoscopy. VR device can reduce patient's breathlessness during flexible bronchoscopy.
OBJECTIVE General To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality).
Specific To compare pain score between patients with or without VR (virtual reality) before and after flexible bronchoscopy To compare Breathlessness score between patient with or without VR (virtual reality) before and after flexible bronchoscopy To compare severity of cough between patient with or without VR (virtual reality) before and after flexible bronchoscopy To compare anxiety between patient with or without VR (virtual reality) before and after flexible bronchoscopy
SIGNIFICANCE OF RESEARCH To determine new methods of audio-visual distraction as a method to increase patient satisfaction and tolerability of flexible bronchoscopy.
To determine if VR is a suitable to be used in the future for all patient undergoing Flexible Bronchoscopy.
This is a prospective interventional study conducted on patients undergoing flexible bronchoscopy under the Respiratory Unit, Department of Internal Medicine in UKMMC, who qualified both the inclusion and exclusion criteria. All eligible patients will be briefed about this study. Subsequently, consent will be obtained from those who are agreeing to participate, from the patient him/herself. The process of briefing and obtaining consent will be done prior to bronchoscopy when patient is in the waiting room. The patient will be randomized into 2 groups by block randomization 1:1(simple randomization), one undergoing flexible bronchoscopy with the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. The other groups will undergo bronchoscopy without any device on Both groups will be given a questionnaire to assess pain, dyspnea and cough using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level) to determine a pre procedural baseline. Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given another VAS questionnaire to assess pain, dyspnea, and cough during the procedure. The patient will also be given the State Trait Anxiety Inventory (STAI) questionnaire together with a satisfaction questionnaire, all of which to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given. The questionnaire and collection of data will not in any way interfere with the bronchoscopy procedure. Both groups with not differ in terms of standard of care during bronchoscopy. The VR device will be sanitized before every use using alcohol wipes so that the risk of infection will be minimized and users will be given disposable hygiene cover.
Standard Operating Procedure for COVID-19, for bronchoscopy. Firstly for the patient: a. Triaging of patients before entering bronchoscopy suite to be performed by medical staff. b. Patient and/or caregiver to scan My Sejahtera/ fill up screening and declaration form c. Ensuring patients to wear face mask. d. Ensuring patients to sanitize their hands using provided hand sanitizer. e. Temperature check. f. Suspected COVID-19 patients are directed to designated COVID-19 screening area. g. Practice of physical distancing of at least 1 meter among patients. h. All patient planned for bronchoscopy should have a Covid-19 Rapid antigen test kit (RTK) or reserve transcriptase polymerase chair reaction (RT-PCR) done at least 24-78hrs before bronchoscopy.
For the Bronchoscopy staff: a. All patients undergoing aerosol generating procedure (AGP) require thorough clinical assessment and COVID-19 diagnostic tests via RT-PCR for nasopharyngeal/ throat swabs as per local hospital protocols. Screening for other type of operation to be done if necessary. b. Appropriate personal protective equipment (PPE) should be worn in the ward for examination or procedures as stated for outpatient services. c. endoscopy and bronchoscopy should not be performed during the COVID-19 pandemic unless there is an absolute need for it. d. Rigid and flexible scope should be done in a designated procedure room to limit exposure to other staffs and patients. e. Appropriate PPE is to be worn for all procedure. f. Non-disposable equipment used during this procedure should be appropriately wrapped and covered to avoid virus contaminations. g. Sterilization of instruments and equipment used during the procedure is done according to infection control protocol. Discard all disposables accordingly.
For Aerosol Generating Procedures (AGPs). a. All procedures and surgeries should be performed while observing appropriate protective measures (PPE) in line with universal airborne, droplet and contact precautions. b. Procedures to be performed in designated COVID-19 operating theatre (OT) and ideally with negative pressure OT. c. All patients undergoing AGP require thorough clinical assessment and COVID-19 diagnostic tests via RT-PCR for nasopharyngeal/ throat swabs as per local hospital protocols. COVID-19 test for other type of operation to be done if necessary. d. If patient is not intubated, a surgical mask should be offered to the patient to wear at all times.
- Conditions
- Flexible Bronchoscopy
- Being tested
- Virtual Reality Device
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 (HUD) that allows users to interact with simulated environments and experience a first-person view (FPV). VR headsets replace the user's natural environment with virtual reality content, such as a movie, a game or a pre-recorded 360-degree VR environment that allows the user to turn and look around, just as in the physical world. Patient undergoing bronchoscopy will be given the device before and during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Patient undergoing Bronchoscopy without use of VR device | No intervention | patients undergoing flexible bronchoscopy without the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice. |
| Patient Undergoing Bronchoscopy with the use of VR device | Experimental | patients undergoing flexible bronchoscopy with the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice. Receives: Device: Virtual Reality Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality) using questionnaire, (0 - not satisfied, 5 extremely satisfied)
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given satisfaction questionnaire to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
Measured: 6 months
Secondary outcomes (4)
to compare pain of patient undergoing flexible bronchoscopy with or without VR (virtual reality), using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given a Visual analog scale (VAS) pain scale before endoscopy and another to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
Measured: 6 months
to compare cough of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given a Visual analog scale (VAS) cough scale before endoscopy and another to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
Measured: 6 months
to compare breathlessness of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given a Visual analog scale (VAS) breathlessness scale before endoscopy and another to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
Measured: 6 months
to compare anxiety of patient undergoing flexible bronchoscopy with or without VR using Stat Trait Anxiety Index (STAI) questionairre.
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given a Stat Trait Anxiety Index (STAI) questionnaire after endoscopy to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 May 2022
- Primary completion31 Aug 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Flexible BronchoscopyStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Faisal Abdul Hamid, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340907
- Sponsor's protocol ID
- ff-2021-506
- Status last verified
- Sep 2022
- First submitted
- 14 Mar 2022
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gunay E, Baki ED, Kokulu S, Ulasli SS, Oz G, Akar O, Bagcioglu E, Unlu M. Impact of multimedia information on bronchoscopy procedure: is it really helpful? Ann Thorac Med. 2015 Jan-Mar;10(1):34-7. doi: 10.4103/1817-1737.146862.
PubMed 25593605Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
PubMed 23860341Ni YL, Lo YL, Lin TY, Fang YF, Kuo HP. Conscious sedation reduces patient discomfort and improves satisfaction in flexible bronchoscopy. Chang Gung Med J. 2010 Jul-Aug;33(4):443-52.
PubMed 20804674Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
PubMed 12628899Prakash UB, Offord KP, Stubbs SE. Bronchoscopy in North America: the ACCP survey. Chest. 1991 Dec;100(6):1668-75. doi: 10.1378/chest.100.6.1668.
PubMed 1959412Lechtzin N, Rubin HR, Jenckes M, White P, Zhou LM, Thompson DA, Diette GB. Predictors of pain control in patients undergoing flexible bronchoscopy. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):440-5. doi: 10.1164/ajrccm.162.2.9910022.
PubMed 10934067Fulkerson WJ. Current concepts. Fiberoptic bronchoscopy. N Engl J Med. 1984 Aug 23;311(8):511-5. doi: 10.1056/NEJM198408233110806. No abstract available.
PubMed 6749209Hirose T, Okuda K, Ishida H, Sugiyama T, Kusumoto S, Nakashima M, Yamaoka T, Adachi M. Patient satisfaction with sedation for flexible bronchoscopy. Respirology. 2008 Sep;13(5):722-7. doi: 10.1111/j.1440-1843.2008.01311.x. Epub 2008 May 29.
PubMed 18513244Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
PubMed 10801169Tusek DL, Church JM, Strong SA, Grass JA, Fazio VW. Guided imagery: a significant advance in the care of patients undergoing elective colorectal surgery. Dis Colon Rectum. 1997 Feb;40(2):172-8. doi: 10.1007/BF02054983.
PubMed 9075752Fernandez E. A classification system of cognitive coping strategies for pain. Pain. 1986 Aug;26(2):141-151. doi: 10.1016/0304-3959(86)90070-9.
PubMed 3531980Miller AC, Hickman LC, Lemasters GK. A distraction technique for control of burn pain. J Burn Care Rehabil. 1992 Sep-Oct;13(5):576-80. doi: 10.1097/00004630-199209000-00012.
PubMed 1452593Rusy LM, Weisman SJ. Complementary therapies for acute pediatric pain management. Pediatr Clin North Am. 2000 Jun;47(3):589-99. doi: 10.1016/s0031-3955(05)70227-3.
PubMed 10835992Hoffman HG, Patterson DR, Carrougher GJ. Use of virtual reality for adjunctive treatment of adult burn pain during physical therapy: a controlled study. Clin J Pain. 2000 Sep;16(3):244-50. doi: 10.1097/00002508-200009000-00010.
PubMed 11014398Gershon J, Zimand E, Pickering M, Rothbaum BO, Hodges L. A pilot and feasibility study of virtual reality as a distraction for children with cancer. J Am Acad Child Adolesc Psychiatry. 2004 Oct;43(10):1243-9. doi: 10.1097/01.chi.0000135621.23145.05.
PubMed 15381891
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy in University Kebangsaan Malaysia Medical Centre (UKMMC).
- ClinicalTrials.gov ID
- NCT05340907
- Acronym / sponsor ID
- ff-2021-506
- Conditions
- Flexible Bronchoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 22 Apr 2022 (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.
Flexible bronchoscopy is an important procedure used worldwide in the diagnosis and treatment of the disease of the of the lungs and airways . Flexible bronchoscopy is an invasive procedure that is utilized to visualize the nasal passages, pharynx, larynx, vocal cords, and tracheal bronchial tree. It is utilized for both the diagnosis and treatment of lung disorders. The procedure may be performed in an endoscopy suite, the operating room, the emergency department, a radiology suite, or at the bedside in the ICU. Flexible bronchoscopy (FB) is a safe procedure widely used in the management of patients with respiratory diseases. FB has close to zero mortality, and major complications are also very rare. Besides being safe and accurate, the comfort of the patient during the procedure is of primary concern of the medical and endoscopy staff.
Flexible Bronchoscopy can be a frightening and painful experience for the patient. There is room to improve the management of pain during FB, as many patients experience pain despite the common use of premedication analgesics and sedatives. In addition, because.
these medications have side effects, including respiratory depression and cardiovascular instability, it would be useful to develop nonpharmacologic approaches to improving the patient experience with painful procedures. The use of less medication may speed recovery from the procedure and facilitate the timely discharge of patients from the hospital. Nonpharmacologic practices, such as guided imagery, hypnosis, and distraction, have been effective in improving patient experiences during stressful or painful medical procedures. Distraction therapy is a technique in which sensory stimuli are provided to patients in order to divert their attention from an unpleasant experience. The use of nature scenes and sounds is an effective tool for distraction and has been successful in a variety of patient settings, including perioperative care, phlebotomy, and burn care. The benefit of nonpharmacologic approaches to analgesia during FB, however, has not been evaluated adequately. A visual reality (VR) device is an apparatus with a head up display (HUD) that projects a video and contains sound, the device is aimed to replace the patient's natural environment with virtual reality content. The use of Virtual reality(VR) device during flexible bronchoscopy has not been studies before.
Detailed description
PROBLEM STATEMENT In Malaysia, flexible bronchoscopy has been well established in many respiratory centers as a means of diagnosis and treatment for many respiratory diseases, however there not many studies into use of nonpharmacological methods of improving patients experience during bronchoscopy. The use of conventional analgesia and sedation is considered standard of care during flexible bronchoscopy. In Respiratory centers, and our own center, Pusat Perubatan UKM (PPUKM), bronchoscopists use fentanyl and midazolam routinely as a means of analgesia during flexible bronchoscopy. There has not been research into the use of Virtual reality (VR) as a method of distraction to reduce anxiety and improve satisfaction in patient undergoing bronchoscopy. Investigators aim to carry out a randomize control trial, to study and compare the use Virtual Reality (VR) device in subjects undergoing flexible bronchoscopy. There are many parameters which the investigators will be looking into, the first will be overall subject's satisfaction with bronchoscope. Investigators will also compare parameter such as anxiety levels during the procedure, pain, cough and also breathlessness.
RESEARCH QUESTION Can VR (Virtual reality) device be used to improve satisfaction, reduce anxiety, pain cough and breathlessness for patients undergoing flexible bronchoscopy
HYPOTHESIS VR device can improve patient's satisfaction of flexible bronchoscopy by using methods of distraction.
VR device can reduce patient's anxiety during flexible bronchoscopy. VR device can reduce patient's pain during flexible bronchoscopy. VR device can reduce patient's cough during flexible bronchoscopy. VR device can reduce patient's breathlessness during flexible bronchoscopy.
OBJECTIVE General To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality).
Specific To compare pain score between patients with or without VR (virtual reality) before and after flexible bronchoscopy To compare Breathlessness score between patient with or without VR (virtual reality) before and after flexible bronchoscopy To compare severity of cough between patient with or without VR (virtual reality) before and after flexible bronchoscopy To compare anxiety between patient with or without VR (virtual reality) before and after flexible bronchoscopy
SIGNIFICANCE OF RESEARCH To determine new methods of audio-visual distraction as a method to increase patient satisfaction and tolerability of flexible bronchoscopy.
To determine if VR is a suitable to be used in the future for all patient undergoing Flexible Bronchoscopy.
This is a prospective interventional study conducted on patients undergoing flexible bronchoscopy under the Respiratory Unit, Department of Internal Medicine in UKMMC, who qualified both the inclusion and exclusion criteria. All eligible patients will be briefed about this study. Subsequently, consent will be obtained from those who are agreeing to participate, from the patient him/herself. The process of briefing and obtaining consent will be done prior to bronchoscopy when patient is in the waiting room. The patient will be randomized into 2 groups by block randomization 1:1(simple randomization), one undergoing flexible bronchoscopy with the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. The other groups will undergo bronchoscopy without any device on Both groups will be given a questionnaire to assess pain, dyspnea and cough using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level) to determine a pre procedural baseline. Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given another VAS questionnaire to assess pain, dyspnea, and cough during the procedure. The patient will also be given the State Trait Anxiety Inventory (STAI) questionnaire together with a satisfaction questionnaire, all of which to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given. The questionnaire and collection of data will not in any way interfere with the bronchoscopy procedure. Both groups with not differ in terms of standard of care during bronchoscopy. The VR device will be sanitized before every use using alcohol wipes so that the risk of infection will be minimized and users will be given disposable hygiene cover.
Standard Operating Procedure for COVID-19, for bronchoscopy. Firstly for the patient: a. Triaging of patients before entering bronchoscopy suite to be performed by medical staff. b. Patient and/or caregiver to scan My Sejahtera/ fill up screening and declaration form c. Ensuring patients to wear face mask. d. Ensuring patients to sanitize their hands using provided hand sanitizer. e. Temperature check. f. Suspected COVID-19 patients are directed to designated COVID-19 screening area. g. Practice of physical distancing of at least 1 meter among patients. h. All patient planned for bronchoscopy should have a Covid-19 Rapid antigen test kit (RTK) or reserve transcriptase polymerase chair reaction (RT-PCR) done at least 24-78hrs before bronchoscopy.
For the Bronchoscopy staff: a. All patients undergoing aerosol generating procedure (AGP) require thorough clinical assessment and COVID-19 diagnostic tests via RT-PCR for nasopharyngeal/ throat swabs as per local hospital protocols. Screening for other type of operation to be done if necessary. b. Appropriate personal protective equipment (PPE) should be worn in the ward for examination or procedures as stated for outpatient services. c. endoscopy and bronchoscopy should not be performed during the COVID-19 pandemic unless there is an absolute need for it. d. Rigid and flexible scope should be done in a designated procedure room to limit exposure to other staffs and patients. e. Appropriate PPE is to be worn for all procedure. f. Non-disposable equipment used during this procedure should be appropriately wrapped and covered to avoid virus contaminations. g. Sterilization of instruments and equipment used during the procedure is done according to infection control protocol. Discard all disposables accordingly.
For Aerosol Generating Procedures (AGPs). a. All procedures and surgeries should be performed while observing appropriate protective measures (PPE) in line with universal airborne, droplet and contact precautions. b. Procedures to be performed in designated COVID-19 operating theatre (OT) and ideally with negative pressure OT. c. All patients undergoing AGP require thorough clinical assessment and COVID-19 diagnostic tests via RT-PCR for nasopharyngeal/ throat swabs as per local hospital protocols. COVID-19 test for other type of operation to be done if necessary. d. If patient is not intubated, a surgical mask should be offered to the patient to wear at all times.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient undergoing Bronchoscopy without use of VR device | No intervention | –patients undergoing flexible bronchoscopy without the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice. |
| Patient Undergoing Bronchoscopy with the use of VR device | Experimental | Device: Virtual Reality Devicepatients undergoing flexible bronchoscopy with the VR device on, they will be shown a video consisting of calming nature scene together with soothing instrumental music. Sedation will be given as per standard practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years old and above
- Patient undergoing flexible bronchoscopy.
- understand and able to give consent (understand English and Malay)
- patient will need a negative covid PCR test as per standard practic
Key exclusion criteria (9 listed)
- Age < 18
- Unable to understand and give consent (does not understand English, Malay)
- Ventilated patient
- Patient who are not comfortable wearing VR device
- Patient who are unable to communicate (illiterate, hearing impairment, mute, blind, Memory impairment)
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 (HUD) that allows users to interact with simulated environments and experience a first-person view (FPV). VR headsets replace the user's natural environment with virtual reality content, such as a movie, a game or a pre-recorded 360-degree VR environment that allows the user to turn and look around, just as in the physical world. Patient undergoing bronchoscopy will be given the device before and during the procedure. | Device | Patient Undergoing Bronchoscopy with the use of VR device |
Primary outcome
To compare satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality) using questionnaire, (0 - not satisfied, 5 extremely satisfied)
Time frame: 6 months
Both groups of patients will be given the same amounts of sedation of midazolam 1 to 2 mg, with a supplemental 1-2mg midazolam and titrating dose of fentanyl from 12.5mg upwards. The interventional arm will be given the VR device to be worn 10 minutes before the procedure and will continue until the procedure is completed. Both groups of patients will be given satisfaction questionnaire to be answered 24 hours after the procedure to minimize any potential amnestic effect of the sedation given.
4 secondary outcomes
to compare pain of patient undergoing flexible bronchoscopy with or without VR (virtual reality), using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Time frame: 6 months
to compare cough of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Time frame: 6 months
to compare breathlessness of patient undergoing flexible bronchoscopy with or without VR (virtual reality),using a 10-point Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level)
Time frame: 6 months
to compare anxiety of patient undergoing flexible bronchoscopy with or without VR using Stat Trait Anxiety Index (STAI) questionairre.
Time frame: 6 months
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 13 Sep 2022.
- Background: PubMed 25593605Gunay E, Baki ED, Kokulu S, Ulasli SS, Oz G, Akar O, Bagcioglu E, Unlu M. Impact of multimedia information on bronchoscopy procedure: is it really helpful? Ann Thorac Med. 2015 Jan-Mar;10(1):34-7. doi: 10.4103/1817-1737.146862.
- Background: PubMed 23860341Du Rand IA, Blaikley J, Booton R, Chaudhuri N, Gupta V, Khalid S, Mandal S, Martin J, Mills J, Navani N, Rahman NM, Wrightson JM, Munavvar M; British Thoracic Society Bronchoscopy Guideline Group. British Thoracic Society guideline for diagnostic flexible bronchoscopy in adults: accredited by NICE. Thorax. 2013 Aug;68 Suppl 1:i1-i44. doi: 10.1136/thoraxjnl-2013-203618. No abstract available.
- Background: PubMed 20804674Ni YL, Lo YL, Lin TY, Fang YF, Kuo HP. Conscious sedation reduces patient discomfort and improves satisfaction in flexible bronchoscopy. Chang Gung Med J. 2010 Jul-Aug;33(4):443-52.
- Background: PubMed 12628899Diette GB, Lechtzin N, Haponik E, Devrotes A, Rubin HR. Distraction therapy with nature sights and sounds reduces pain during flexible bronchoscopy: a complementary approach to routine analgesia. Chest. 2003 Mar;123(3):941-8. doi: 10.1378/chest.123.3.941.
- Background: PubMed 1959412Prakash UB, Offord KP, Stubbs SE. Bronchoscopy in North America: the ACCP survey. Chest. 1991 Dec;100(6):1668-75. doi: 10.1378/chest.100.6.1668.
- Background: PubMed 10934067Lechtzin N, Rubin HR, Jenckes M, White P, Zhou LM, Thompson DA, Diette GB. Predictors of pain control in patients undergoing flexible bronchoscopy. Am J Respir Crit Care Med. 2000 Aug;162(2 Pt 1):440-5. doi: 10.1164/ajrccm.162.2.9910022.
- Background: PubMed 6749209Fulkerson WJ. Current concepts. Fiberoptic bronchoscopy. N Engl J Med. 1984 Aug 23;311(8):511-5. doi: 10.1056/NEJM198408233110806. No abstract available.
- Background: PubMed 18513244Hirose T, Okuda K, Ishida H, Sugiyama T, Kusumoto S, Nakashima M, Yamaoka T, Adachi M. Patient satisfaction with sedation for flexible bronchoscopy. Respirology. 2008 Sep;13(5):722-7. doi: 10.1111/j.1440-1843.2008.01311.x. Epub 2008 May 29.
- Background: PubMed 10801169Lang EV, Benotsch EG, Fick LJ, Lutgendorf S, Berbaum ML, Berbaum KS, Logan H, Spiegel D. Adjunctive non-pharmacological analgesia for invasive medical procedures: a randomised trial. Lancet. 2000 Apr 29;355(9214):1486-90. doi: 10.1016/S0140-6736(00)02162-0.
- Background: PubMed 9075752Tusek DL, Church JM, Strong SA, Grass JA, Fazio VW. Guided imagery: a significant advance in the care of patients undergoing elective colorectal surgery. Dis Colon Rectum. 1997 Feb;40(2):172-8. doi: 10.1007/BF02054983.
- Background: PubMed 3531980Fernandez E. A classification system of cognitive coping strategies for pain. Pain. 1986 Aug;26(2):141-151. doi: 10.1016/0304-3959(86)90070-9.
- Background: PubMed 1452593Miller AC, Hickman LC, Lemasters GK. A distraction technique for control of burn pain. J Burn Care Rehabil. 1992 Sep-Oct;13(5):576-80. doi: 10.1097/00004630-199209000-00012.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 in people with Flexible Bronchoscopy, run by National University of Malaysia at 3 sites 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 4 inclusion and 9 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 13 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 satisfaction and tolerability of patients undergoing flexible bronchoscopy with or without VR (virtual reality) using questionnaire, (0 - not satisfied, 5 extremely satisfied) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05340907, which also lists 24 linked publications.
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 13 Sep 2022; AzTrials last refreshed its copy on 29 Oct 2026.