Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0065166490
Study information
Scientific title
Acronym
Study hypothesis
A pilot study to compare the doses of anaesthetic required to induce anaesthesia in patients receiving day-case surgery who have listened to one of two types of audio during the preceding hour.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Surgery: Anaesthesia
Intervention
Patients will be randomised to either listen to their own music or binaural beat audio.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measure
The study will compare the effect of preoperative binaural beat audio with patient-selected music on the amount of propofol required to achieve a BIS score of 50.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/11/2005
Overall trial end date
31/05/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adults receiving general anaesthesia for day case surgery at Sunderland General Hospital.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
20 patients will be recruited, 10 in each group
Participant exclusion criteria
1. Patients under 16 years old
2. Patients arriving to the Day Unit within one hour of surgery (logistical exclusion)
Recruitment start date
01/11/2005
Recruitment end date
31/05/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City Hospitals Sunderland NHS Foundation Trust (UK), NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16115248
Publication citations
-
Results
Padmanabhan R, Hildreth AJ, Laws D, A prospective, randomised, controlled study examining binaural beat audio and pre-operative anxiety in patients undergoing general anaesthesia for day case surgery., Anaesthesia, 2005, 60, 9, 874-877, doi: 10.1111/j.1365-2044.2005.04287.x.