A randomised controlled study examining binaural beat audio and preoperative anxiety in patients undergoing general anaesthesia for day case surgery

ISRCTN ISRCTN73181407
DOI https://doi.org/10.1186/ISRCTN73181407
Secondary identifying numbers N0065125468
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
13/05/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr D Laws
Scientific

Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom

Phone +44 (0)191 5656256 ext 42446

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSigns and Symptoms: Pre operative anxiety
InterventionPatients randomised into 1 of 3 groups.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/06/2003
Completion date01/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants108
Key inclusion criteria3 groups of 36 patients undergoing general anaesthesia for day case surgery.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/06/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

City Hospitals Sunderland NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/09/2005 Yes No