Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000777695
Ethics application status
Approved
Date submitted
7/07/2014
Date registered
21/07/2014
Date last updated
21/07/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of hypnosis on bleeding
Scientific title
The effects of hypnosis on bleeding in healthy adult participants
Secondary ID [1] 284931 0
nil
Universal Trial Number (UTN)
U1111-1158-9679
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
healthy adult participants 292406 0
Condition category
Condition code
Anaesthesiology 292724 292724 0 0
Other anaesthesiology

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following ethics approval and written informed participant consent, study participants will be asked to sit comfortably in a vacant clinical room such as DOSA. Here subjects will have a standardised hypnotic induction by an experienced hypnotist (AMC) using an eye fixation technique and progressive muscle relaxation for deepening the trance state. After suggestions for the development of arm anaesthesia using anaesthetic glove imagery, small areas of skin over the anatomical snuff box of each hand will be cleaned by the hypnotherapist / anaesthetist with antiseptic wipes.
After obtaining permission from the volunteer while in hypnosis (either with a finger signal or nod of the head) a 23 gauge needle will be inserted through a skin fold overlying the anatomical snuff box in each hand. Following randomisation of which arm will stay in hypnosis (the participant’s left or right) suggestions will be given for the allocated arm to stay in hypnosis when the needle is removed and that bleeding will be controlled so that the skin stays dry. Similarly in the contralateral arm allocated to bleed normally when the needle is removed, it will be suggested that when the needle is removed the arm will come out of hypnosis and the blood vessels return to their normal caliber so that bleeding occurs normally. A second researcher will then be asked to enter the room to measure our key outcomes. Both needles will then be removed simultaneously and bleeding from each puncture site measured by this researcher using filter blotting paper to absorb any blood and a stopwatch to time when bleeding starts and ceases in each hand following needle removal.
The Randomisation will be obtained by a computer generated random number sequence and allocation concealment assured by using consecutively numbered opaque envelopes containing the randomisation sequence. The envelopes will be opened after needle insertions but before the outcome assessor enters the room. Following the hypnosis intervention a blinded observer will measure bleeding using absorbant standardised blotting paper on removal of the needles and the outcome assessor will measure the spread of blood absorbed by the paper in mms and he/she will be asked which arm they believe to be hypnotized.
Dependent on equipment availability we also plan to use thermo-imaging of the puncture site as a measure of temperature change and local blood flow as a secondary outcome. Videotaping of the whole process is also planned.
We plan to recruit 20 subjects in the first instance.
Following completion of all measurements, participants will have their hypnosis terminated in a standardised fashion and all prior hypnotic suggestions removed as subjects return to normal conscious awareness.
Data collection will be via a data-sheet for each patient. Study data will then be transcribed on an excel spreadsheet for further analyses. Descriptive statistics will be reported, Chi squared between arms for dichotomous outcomes and students t test for continuous data such as blood blotting paper measurements will be used as appropriate. Differences in the measurements of bleeding outcomes between the two allocated hypnosis and non hypnosis hands will be analysed and a P values < 0.05 will be considered significant.
Intervention code [1] 289759 0
Other interventions
Comparator / control treatment
Following randomisation of which arm will stay in hypnosis (the participant’s left or right) the contralateral arm, which is the control arm allocated to bleed normally when the needle is removed, will receive suggestions that the blood vessels return to their normal caliber so that bleeding occurs normally
Control group
Active

Outcomes
Primary outcome [1] 292566 0
Amount of blood loss

Both needles will be removed simultaneously and bleeding from each puncture site measured by this researcher using filter blotting paper to absorb any blood
Timepoint [1] 292566 0
3 minutes
Secondary outcome [1] 309252 0
Bleeding time

A stopwatch to time when bleeding starts and ceases in each hand following needle removal
Timepoint [1] 309252 0
5 Minutes

Eligibility
Key inclusion criteria
Healthy volunteers will be recruited within our workplace and circle of acquaintances.
Inclusion criteria:
- age: >18
- healthy adults
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria
- age: <18
- coagulopathic
- mental disease
- drug or alcohol dependence
- chronic pain that has not been investigated and diagnosed by a qualified doctor

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Healthy volunteers will be recruited within our workplace and circle of acquaintances.
The Randomisation will be obtained by a computer generated random number sequence and allocation concealment assured by using consecutively numbered opaque envelopes containing the randomisation sequence. The envelopes will be opened after needle insertions but before the outcome assessor enters the room. Following the hypnosis intervention a blinded observer will measure bleeding using absorbant standardised blotting paper on removal of the needles and the outcome assessor will measure the spread of blood absorbed by the paper in mms and he/she will be asked which arm they believe to be hypnotized.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be obtained by a computer generated random number sequence and allocation concealment assured by using consecutively numbered opaque envelopes containing the randomisation sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data collection will be via a data-sheet for each patient. Study data will then be transcribed on an excel spreadsheet for further analyses. Descriptive statistics will be reported, Chi squared between arms for dichotomous outcomes and students t test for continuous data such as blood blotting paper measurements will be used as appropriate. Differences in the measurements of bleeding outcomes between the two allocated hypnosis and non hypnosis hands will be analysed and a P values < 0.05 will be considered significant

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2708 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 8420 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 289559 0
Self funded/Unfunded
Name [1] 289559 0
Dr. Allan Cyna
Country [1] 289559 0
Australia
Funding source category [2] 289560 0
Self funded/Unfunded
Name [2] 289560 0
Dr. Yasmin Endlich
Country [2] 289560 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
Women's and Children's Hospital
72 King William Road
North Adelaide, 5006
South Australia
Country
Australia
Secondary sponsor category [1] 288241 0
None
Name [1] 288241 0
Address [1] 288241 0
Country [1] 288241 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291298 0
Women's and Children's Hospital
Ethics committee address [1] 291298 0
72 King William Road
North Adelaide 5006
South Australia
Ethics committee country [1] 291298 0
Australia
Date submitted for ethics approval [1] 291298 0
Approval date [1] 291298 0
29/05/2014
Ethics approval number [1] 291298 0
14/WCHN/029

Summary
Brief summary
The planned study is a pilot study performed in order to obtain baseline data for a larger randomised study in which we plan to compare bleeding time, amount of bleeding, local temperature and blood flow over the puncture sites between a hypnotised and non hypnotised arm of the same volunteer.
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 115 115 0 0
/AnzctrAttachments/366672-Ethics protocoll final AMC edits 17th March.pdf

Contacts
Principal investigator
Name 49746 0
Dr Allan Cyna
Address 49746 0
Women's and Children's Hospital
72 King William Road
5006 North Adelaide
South Australia
Country 49746 0
Australia
Phone 49746 0
+61 (08) 8161 7000
Fax 49746 0
Email 49746 0
[email protected]
Contact person for public queries
Name 49747 0
Dr Allan Cyna
Address 49747 0
Women's and Children's Hospital
72 King William Road
5006 North Adelaide
South Australia
Country 49747 0
Australia
Phone 49747 0
+61 (08) 8161 7000
Fax 49747 0
Email 49747 0
[email protected]
Contact person for scientific queries
Name 49748 0
Dr Allan Cyna
Address 49748 0
Women's and Children's Hospital
72 King William Road
5006 North Adelaide
South Australia
Country 49748 0
Australia
Phone 49748 0
+61 (08) 8161 7000
Fax 49748 0
Email 49748 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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