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Trial registered on ANZCTR

Registration number

ACTRN12617000486325

Ethics application status

Approved

Date submitted

31/03/2017

Date registered

4/04/2017

Date last updated

4/08/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

The Effect of Applied Muscle Tension On Vasovagal Reactions Study

Scientific title

A three-arm randomised controlled trial comparing the effect of applied muscle tension at different time points to a control condition on reducing self-reported vasovagal symptoms among whole blood donors

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

MOVE

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prevention of vasovagal reactions in whole blood donors

Condition category

Condition code

Public Health

Health service research

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This study will investigate the effectiveness of applied muscle tension (AMT) exercises in preventing vasovagal symptoms in whole blood donation through the involvement of donor centre staff. Donors will be asked by donor centre staff to use AMT in 10-second cycles: crossing their legs at the ankles, tensing their inner thigh and abdominal muscles for 5 seconds, and then relaxing for 5 seconds.

This is an open-label, three-arm, randomised, controlled, multicentre trial. Using sequentially numbered, opaque sealed envelopes, whole blood donors aged between 18 and 80 years will be randomly allocated to one of three study conditions:

1) AMT during the entire donation – donors assigned to this study condition will be instructed to practice AMT from needle insertion until they leave the donation couch. The duration of the exercises will be dependent on the duration of the donation (average donation time is 8 minutes plus 5 minutes recovering on the donation couch). All donors will receive an instruction card and collection staff will provide prompts during the donation to ensure donor adherence.

2) AMT at key time points – donors assigned to this study condition will be instructed to practice 5 cycles of AMT, then switch legs and repeat 5 cycles at three high risk time points: starting AMT just before needle insertion, just before needle removal, and just before leaving donation couch. The duration of AMT at each time point will be approximately 100 seconds (10 cycles). All donors will receive an instruction card and collection staff will provide a prompt to the donor at each time point.

3) Business as usual – donors assigned to this condition will undergo their donation as per usual and no instructions will be provided regarding AMT. Collection staff will not provide any additional prompts.

At the end of the donation, the donor will be asked to complete a questionnaire to assess use of AMT and self-reported vasovagal symptoms.

Intervention code [1]

Prevention

Comparator / control treatment

Participants assigned to this condition will undergo their whole blood donation as per usual and no instructions will be provided regarding AMT.

Control group

Active

Outcomes

Primary outcome [1]

The primary outcome will be a difference between the intervention groups and the control group in self-reported
VVR symptoms. This will be measured using the Blood Donation Reaction Inventory.

Timepoint [1]

Immediately after their whole blood donation at the donation site.

Secondary outcome [1]

Difference between intervention and control groups in donation satisfaction as reported via study specific survey.

Timepoint [1]

Immediately after their whole blood donation at the donation site.

Secondary outcome [2]

Difference between intervention and control groups fear and anxiety scores.

This is measured post-donation using a single item assessing fear of blood draw which has been validated in blood donation research. This question has been adapted to create another item specifically for this study to measure fear of feeling faint.

Timepoint [2]

Immediately after their whole blood donation at the donation site.

Secondary outcome [3]

Difference between intervention and control groups in bleed time of the donation.

Data will be obtained through linkage to Blood Service Records.

Timepoint [3]

Day of donation

Secondary outcome [4]

Retention rates (rates of return for subsequent donations) between intervention and control groups.

Data will be obtained through linkage to Blood Service Records.

Timepoint [4]

6 months from the initial donation date.

Eligibility

Key inclusion criteria

Inclusion criteria:
1) Adults, greater than or equal to 18 years and less than 81 years
2) Less than 10 prior donations
3) Generally eligible for blood donation as per the current Guidelines for the Selection of Blood Donors (GSBD)
4) Willing and able to provide written informed consent
5) Has a whole blood donation appointment

Minimum age

18 Years

Maximum age

80 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Exclusion criteria:
1) Not eligible to donate whole blood as per current Guidelines for the Selection of Blood Donors (GSBD)
2) Participation in an Australian Red Cross Blood Service study in the last 6 months
3) Donor with an immobilisation, even partial, of a lower limb
4) Donors who have been converted to an apheresis donation on the day

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)

Sequentially numbered, opaque sealed envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation stratified by donor status (new or returned donor).

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A sample of 750 whole blood donors would provide 80% power at the 5% or a=0.05 level to detect a minimum difference in BDRI scores of 0.5 in the primary outcome.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

10/04/2017

Actual

19/04/2017

Date of last participant enrolment

Anticipated

Actual

28/07/2017

Date of last data collection

Anticipated

Actual

28/07/2017

Sample size

Target

750

Accrual to date

Final

740

Recruitment in Australia

Recruitment state(s)

NSW,SA,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Red Cross Blood Service

Address [1]

National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country [1]

Australia

Primary sponsor type

Government body

Name

Australian Red Cross Blood Service

Address

National Office
Level 3, 417 St Kilda Rd
Melbourne VIC 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Australian Red Cross Blood Service Human Research Ethics Committee

Ethics committee address [1]

Sydney Processing Centre
17 O'Riordan Street
Alexandria NSW 2015

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

28/02/2017

Approval date [1]

30/03/2017

Ethics approval number [1]

Summary

Brief summary

A common complication in whole blood donation is a vasovagal reaction (VVR), being 90% of all incidence reports. A VVR causes a donor to feel light-headed, dizzy or faint during or after their donation. These reactions can be triggered by pain or emotions (e.g., fear of needles), or when standing up too quickly after donation. These reactions have a negative impact on donation satisfaction, donor safety and wellbeing, and donor return rates. VVRs pose a particularly high risk to first-time donors, those aged less than 30 years, females, individuals with a low body weight, and donors who report high pre-donation anxiety. In 2016 in Australia, 58% of whole blood donors did not return to donate within six months following a phlebotomist-registered reaction compared to 35% who had an uncomplicated first donation. Therefore, reducing risks to donors is inherently important.

A technique which has received increasing support in reducing the rate of VVRs is applied muscle tension (AMT). AMT has been indicated to benefit the donor both physiologically, through an immediate increase in blood pressure, and psychologically, through distraction and anxiety reduction. At the Australian Red Cross Blood Service, AMT is currently included in the standard operating procedures to treat VVR but international studies have demonstrated the potential of utilising the technique as a prevention method. Practicing AMT during the entire donation procedure results in significantly fewer self-reported VVRs, increased completed donations, less chair reclining, reduced feelings of anxiety and greater intentions to return. However, these studies have reported low adherence to the technique among donors: only 22% of study participants reported using AMT throughout their donation. Despite growing evidence of the efficacy of AMT in reducing VVR, no research has examined how AMT can be successfully implemented into the routine blood donation procedure and maximise donor adherence. Consequently, the impact of AMT in day to day practice has not been examined and its potential to increase donor retention and contribute to the maintenance of a stable blood supply has yet to be fully realised. 

The overall aim of this project is to examine the effectiveness of AMT within Australian donor centres in a randomised controlled trial.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Amanda Thijsen

Address

Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan Street
Alexandria NSW 2015

Country

Australia

Phone

+61 2 9234 2493

Fax

athijsen@redcrossblood.org.au

Contact person for public queries

Name

Amanda Thijsen

Address

Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan Street
Alexandria NSW 2015

Country

Australia

Phone

+61 2 9234 2493

Fax

athijsen@redcrossblood.org.au

Contact person for scientific queries

Name

Amanda Thijsen

Address

Australia Red Cross Blood Service
Sydney Processing Centre
17 O'Riordan Street
Alexandria NSW 2015

Country

Australia

Phone

+61 2 9234 2493

Fax

athijsen@redcrossblood.org.au

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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No additional documents have been identified.

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