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
Protocol serial number	N0065125468
Sponsor	Department of Health
Funder	City Hospitals Sunderland NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr D Laws
Scientific

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

Phone	+44 (0)191 5656256 ext 42446

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Signs and Symptoms: Pre operative anxiety
Intervention	Patients randomised into 1 of 3 groups.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/12/2005

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	108
Key inclusion criteria	3 groups of 36 patients undergoing general anaesthesia for day case surgery.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/06/2003
Date of final enrolment	01/12/2005

Department of Anaesthesia

Sunderland
SR4 7TP
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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