How does virtual reality affect patients’ experience when undergoing awake surgery?

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2020
INTERVENTION: Method of Randomisation The randomization process will be undertaken by a person who will not play any other part in the research project. It will be done using the web (pseudo)randomization service: https://www.randomizer.org/. There will be a block randomisation of two groups of 20 to yield even numbers in each group. A series of numbered, sealed packages will be produced with individual numbers written on them, which must be opened in numerical order. Participants will be randomised on the day of surgery by the opening of an opaque envelope determining their group allocation. They will be assigned to one of two groups: a control group or an intervention group. In addition to any intervention, both groups will receive care‐as‐usual (CAU). Care‐As‐Usual For these procedures, the patients' anaesthetic treatment options are discussed by the surgeon at the time of being listed for surgery. If the patient chooses to have awake surgery under a regional anaesthesia block then they are listed on specific theatre sessions. Sedation and general anaesthesia are not routinely used during these sessions as it creates organisational problems. Sedation is not offered pre‐operatively again, however if sometimes be accommodated. Patients will be invited to take part in the study after they have made their anaesthetic treatment choice and have been listed on a 'regional block list'. If the participant requests sedation during the study, this will be recorded and the participant withdrawn from the remainder of the intervention period. Data collected up to the point of withdrawal will be included for analysis. No formal distraction method will be offered CONDITION: Patients undergoing upper limb surgery under regional or local anaesthesia ; Surgery PRIMARY OUTCOME: Patient anxiety, measured by STAI‐S score before and during awake surgery at KTS, after 15 minutes following KTS and after 10 minutes in recovery SECONDARY OUTCOME: ; 1. Patient satisfaction, measured by the Bauer patient satisfaction tool via a telephone call at 48 hours after discharge; 2. Physiological parameters which are potential indicators of patient anxiety (heart rate and blood pressure) at KTS, 15 minutes after KTS and after 10 minutes in recovery; INCLUSION CRITERIA: Study population: 1. Aged older than 18 years 2. Presenting at the Royal United Hospital, Bath for upper limb surgery 3. Undergoing upper limb surgery under local or regional anaesthesia alone INCLUSION CRITERIA: 1. Scheduled for elective upper limb surgery 2. Intended anaesthetic technique to be regional or local anaesthesia alone 3. Body mass index 18‐40 kg/m² 4. American Society of Anaesthetists (ASA) grade I‐III
Epistemonikos ID: a16df27a89188a3e60f96a5f749acb8ea0aead3a
First added on: Aug 24, 2024