A randomised, controlled pilot study to compare the effect of preoperative binaural beat audio with patient-selected music on subsequent anaesthetic drug requirements
| ISRCTN | ISRCTN55755275 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55755275 |
| Protocol serial number | N0065166490 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | City Hospitals Sunderland NHS Foundation Trust (UK), NHS R&D Support Funding |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 17/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
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
Scientific
Department of Anaesthesia
Sunderland Royal Hospital
Kayll Road
Sunderland
SR4 7TP
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Anaesthesia |
| Intervention | Patients will be randomised to either listen to their own music or binaural beat audio. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | Adults receiving general anaesthesia for day case surgery at Sunderland General Hospital. |
| Key exclusion criteria | 1. Patients under 16 years old 2. Patients arriving to the Day Unit within one hour of surgery (logistical exclusion) |
| Date of first enrolment | 01/11/2005 |
| Date of final enrolment | 31/05/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Anaesthesia
Sunderland
SR4 7TP
United Kingdom
SR4 7TP
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
