UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	An observational study of the effects of anaesthetic room interventions on patient anxiety and their perceptions of a general anaesthetic.
Title of the study (Brief title)	An observational study of the effects of anaesthetic room interventions on patient anxiety.
Region	Europe

Condition
Condition	Anxiety
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We aim to quantify the level of anxiety experienced by patients immediately before unconsciousness and to observe whether practical interventions by the anaesthetic team affect these anxiety levels.
Basic objectives2	Others
Basic objectives -Others	Quantifying preoperative anxiety - an observational study.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We will quantify anxiety levels by observing patient cardiovascular variables and using an anxiety screening questionnaire postoperatively. Some patients will also have a more detailed structured interview postoperatively to explore patient experience.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients having a general anaesthetic for elective surgery at St James's University Hospital, Leeds.
Key exclusion criteria	Patients who: - are unable to complete the questionnaires (e.g. language barrier or mental capacity issues) - take drugs which will affect their heart rate and blood pressure response to stress - are having major surgery requiring awake epidural or vascular lines inserted before induction. - are scheduled to receive prolonged sedative drugs postoperatively.
Target sample size	40

Research contact person
Name of lead principal investigator	Dr Andrew Lumb
Organization	St James's University Hospital Leeds Teaching Hospital Trust
Division name	Department of Anaesthesia
Address	Beckett Street, Leeds, LS9 7TF, U.K.
TEL	00441132065789
Email	a.lumb@leeds.ac.uk

Public contact
Name of contact person	Dr Andrew Lumb
Organization	St James's University Hospital
Division name	Department of Anaesthesia
Address	Beckett Street, Leeds, LS9 7TF. U.K.
TEL	00441132065789
Homepage URL
Email	a.lumb@leeds.ac.uk

Sponsor
Institute	Leeds Teaching Hospital Trust Research and Innovation 34 Hyde Terrace Leeds LS2 9LN
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	210363
Org. issuing International ID_1	Integrated Research Application System
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 15 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 02 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry	2017 Year 06 Month 13 Day
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will be observing patient anxiety in the anaesthetic room by recording cardiovascular variables and the effect of interventions by the anaesthetic team. Postoperatively the patients will complete an anxiety questionnaire and then several of these patients will undergo a more detailed interview on their experience.

Management information
Registered date	2017 Year 02 Month 15 Day
Last modified on	2017 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029998