Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0065125468
Study information
Scientific title
Acronym
Study hypothesis
The study will determine whether binaural beat audio has a superior anxiolytic effect than audio alone in patients about to receive general anaesthesia for day case surgery.
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
Signs and Symptoms: Pre operative anxiety
Intervention
Patients randomised into 1 of 3 groups.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/06/2003
Overall trial end date
01/12/2005
Reason abandoned
Eligibility
Participant inclusion criteria
3 groups of 36 patients undergoing general anaesthesia for day case surgery.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
108
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/06/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
City Hospitals Sunderland NHS Trust (UK)
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
Results - basic reporting
Publication summary
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.