Condition category
Signs and Symptoms
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
13/05/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr D Laws

ORCID ID

Contact details

Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
+44 (0)191 5656256 ext 42446

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

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

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

  1. 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.

Additional files

Editorial Notes