Patient Satisfaction and Tolerability Using Virtual Reality (VR) as Adjunctive Treatment During Flexible Bronchoscopy

NCT05340907 | Completed

• 1 other identifier: ff-2021-506
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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. 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.

Conditions

Flexible Bronchoscopy

Outcome Measures

Primary Outcomes (1)

• 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.

  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)

  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)

  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)

  6 months

• to compare anxiety of patient undergoing flexible bronchoscopy with or without VR using Stat Trait Anxiety Index (STAI) questionairre.

  6 months

Study Arms (2)

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.

Device: Virtual Reality Device

Interventions

Virtual Reality Device DEVICE

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.

Patient Undergoing Bronchoscopy with the use of VR device

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• Patient undergoing other invasive examination planned alongside bronchoscopy.
• Patient with earlier history of bronchoscopy
• Patient with cranial-facial deformity

Sponsors & Collaborators

• National University of Malaysia: lead

Study Sites (3)

University Kebangsaan Malaysia Medical Center

Bandar Tun Razak, Cheras, 56000, Malaysia

Location

National University of Malaysia

Cheras, Kuala Lumpur, 50600, Malaysia

Location

University Kebangsaan Malaysia Medical Centre

Cheras, Kuala Lumpur, 56000, Malaysia

Location

Related Publications (24)

• 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.

  PMID: 25593605 BACKGROUND

• Du 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.

  PMID: 23860341 BACKGROUND

• Ni 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.

  PMID: 20804674 BACKGROUND

• Diette 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.

  PMID: 12628899 BACKGROUND

• Prakash 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.

  PMID: 1959412 BACKGROUND

• Lechtzin 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.

  PMID: 10934067 BACKGROUND

• Fulkerson WJ. Current concepts. Fiberoptic bronchoscopy. N Engl J Med. 1984 Aug 23;311(8):511-5. doi: 10.1056/NEJM198408233110806. No abstract available.

  PMID: 6749209 BACKGROUND

• Hirose 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.

  PMID: 18513244 BACKGROUND

• Lang 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.

  PMID: 10801169 BACKGROUND

• Tusek 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.

  PMID: 9075752 BACKGROUND

• Fernandez 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.

  PMID: 3531980 BACKGROUND

• Miller 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.

  PMID: 1452593 BACKGROUND

• Rusy 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.

  PMID: 10835992 BACKGROUND

• Hoffman 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.

  PMID: 11014398 BACKGROUND

• Gershon 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.

  PMID: 15381891 BACKGROUND

• Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. doi: 10.1089/cpb.2006.9.207.

  PMID: 16640481 BACKGROUND

• Casalini AG, Majori M, Anghinolfi M, Burlone E, D'Ippolito R, Toschi M, Pisi G, Barantani D, Ghasempour D, Monica M. Foreign body aspiration in adults and in children: advantages and consequences of a dedicated protocol in our 30-year experience. J Bronchology Interv Pulmonol. 2013 Oct;20(4):313-21. doi: 10.1097/LBR.0000000000000024.

  PMID: 24162114 BACKGROUND

• De S. Assessment of patient satisfaction and lidocaine requirement during flexible bronchoscopy without sedation. J Bronchology Interv Pulmonol. 2009 Jul;16(3):176-9. doi: 10.1097/LBR.0b013e3181afca25.

  PMID: 23168547 BACKGROUND

• Cabrini L, Gioia L, Gemma M, Melloni G, Carretta A, Ciriaco P, Puglisi A. Acupuncture for diagnostic fiberoptic bronchoscopy: a prospective, randomized, placebo-controlled study. Am J Chin Med. 2006;34(3):409-15. doi: 10.1142/S0192415X06003941.

  PMID: 16710890 BACKGROUND

• Jeppesen E, Pedersen CM, Larsen KR, Walsted ES, Rehl A, Ehrenreich J, Schnoor S, Backer V. Listening to music prior to bronchoscopy reduces anxiety - a randomised controlled trial. Eur Clin Respir J. 2019 Mar 17;6(1):1583517. doi: 10.1080/20018525.2019.1583517. eCollection 2019.

  PMID: 30915199 BACKGROUND

• Triller N, Erzen D, Duh S, Petrinec Primozic M, Kosnik M. Music during bronchoscopic examination: the physiological effects. A randomized trial. Respiration. 2006;73(1):95-9. doi: 10.1159/000089818. Epub 2005 Nov 15.

  PMID: 16293960 BACKGROUND

• Nilsson U. The anxiety- and pain-reducing effects of music interventions: a systematic review. AORN J. 2008 Apr;87(4):780-807. doi: 10.1016/j.aorn.2007.09.013.

  PMID: 18395022 BACKGROUND

• Navidian A, Moulaei N, Ebrahimi Tabas E, Solaymani S. The effect of audiovisual distraction on the tolerability of flexible bronchoscopy: a randomized trial. Clin Respir J. 2018 Jan;12(1):76-83. doi: 10.1111/crj.12486. Epub 2016 May 10.

  PMID: 27116084 BACKGROUND

• Garrett B, Taverner T, Gromala D, Tao G, Cordingley E, Sun C. Virtual Reality Clinical Research: Promises and Challenges. JMIR Serious Games. 2018 Oct 17;6(4):e10839. doi: 10.2196/10839.

  PMID: 30333096 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 14, 2022
• First Posted: April 22, 2022
• Study Start: May 1, 2022
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: September 13, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

MY (3)