Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
17/03/2009
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

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 measures

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

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

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

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

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