UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026139 |
|---|---|
| Receipt number | 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 17:52:43 |
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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
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
a.lumb@leeds.ac.uk
Sponsor or person
Institute
Leeds Teaching Hospital Trust
Research and Innovation
34 Hyde Terrace
Leeds
LS2 9LN
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029998
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
