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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000026139
Receipt No. R000029998
Scientific Title An observational study of the effects of anaesthetic room interventions on patient anxiety and their perceptions of a general anaesthetic.
Date of disclosure of the study information 2017/02/15
Last modified on 2017/08/17

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Basic information
Public title An observational study of the effects of anaesthetic room interventions on patient anxiety and their perceptions of a general anaesthetic.
Acronym An observational study of the effects of anaesthetic room interventions on patient anxiety.
Scientific Title An observational study of the effects of anaesthetic room interventions on patient anxiety and their perceptions of a general anaesthetic.
Scientific Title:Acronym 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
1st name
Middle name
Last name Dr Andrew Lumb
Organization St James's University Hospital
Leeds Teaching Hospital Trust
Division name Department of Anaesthesia
Zip code
Address Beckett Street, Leeds, LS9 7TF, U.K.
TEL 00441132065789
Email a.lumb@leeds.ac.uk

Public contact
Name of contact person
1st name
Middle name
Last name Dr Andrew Lumb
Organization St James's University Hospital
Division name Department of Anaesthesia
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2017 Year 02 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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