Study design
anxiety, pain, cough, breathlessness, memory impairment, craniofacial deformity
HEARING IMPAIRMENT, MAY, SECONDARY, BLIND
This was an open-label, prospective interventional single-center study conducted on participants undergoing FB under the Respiratory Unit, UKMMC between May 2022 and August 2022. The study was approved by the Research Ethics Committee, University Kebangsaan Malaysia, FF-2021–506, and registered with clinical trial number on 22/04/2022 (NCT05340907). Written informed consents were obtained from all participants prior to enrollment in this study according to international guidelines.The sample size calculation was based on a study by Navidian et al.; using pain as a comparison between the intervention and control group, which is normally distributed with a standard deviation (SD) of 1.64 [All participants who were planned for FB were recruited. We included the following: age 18 years and above; participants who could understand and give consent; and participants who had a negative covid polymerase chain reaction (PCR) or antigen test as per standard practice before bronchoscopy.Participants were excluded if they were below the age of 18; unable to understand or give consent; those ventilated; not comfortable wearing VR device; who were unable to communicate (illiterate, had hearing impairment, mute, blind or had memory impairment); with craniofacial deformity; on sedative medication other than sedation given for bronchoscopy; undergoing other invasive examination planned alongside bronchoscopy; had bronchoscopy done in the past 12 months.The primary outcome was to compare the satisfaction of participants undergoing FB with or without VR using a 5-point Likert scale satisfaction questionnaire (1 – very dissatisfied, 2-dissatisfied, 3-neutral, 4-satisfied, 5-very satisfied). The secondary outcome was to compare tolerability (pain, breathlessness, and cough) of participants undergoing FB with or without VR, using a 10 cm Visual analogue scale (VAS), ranging from 0 (no bother) to 10 (worst intolerable level). We also compared the anxiety of participants undergoing FB with or without VR using the State-Trait-Anxiety-Inventory (STAI) score. These questionnaires were administered in English or Malay, depending on the participants' preference.STAI questionnaire is the “gold standard” for measuring procedural anxiety [