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Trial registered on ANZCTR


Registration number
ACTRN12616001415493
Ethics application status
Approved
Date submitted
6/10/2016
Date registered
11/10/2016
Date last updated
29/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of different preparation information on side effects following intravenous iron infusion
Scientific title
Can changing standard preparation information to include an explanation of the nocebo effect reduce side effect reporting after intravenous iron infusion?
Secondary ID [1] 290279 0
None
Universal Trial Number (UTN)
U1111-1188-4048
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Intravenous iron infusion
-Indicated for patients with iron deficiency anaemia for whom oral iron is considered considered unsuitable or has been unsuccessful
e.g. due to malabsorption, continuing blood loss, poor adherence or intolerance to oral iron, preoperative iron deficiency anaemia 300515 0
Condition category
Condition code
Anaesthesiology 300376 300376 0 0
Other anaesthesiology
Blood 300385 300385 0 0
Anaemia
Mental Health 300386 300386 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief name: Comparison of effect of standard information vs. standard information plus nocebo explanation on side effect reporting after intravenous iron infusion.

Participants (patients receiving IV iron infusion at Auckland City Hospital) who are randomised into the intervention group will receive a standard consultation for IV iron infusion (including side effect information) plus an explanation of nocebo effect. The nocebo explanation will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon.

The intervention consultation will be delivered by a Consultant Anaesthetist according to a standardised script.
The mode of delivery will be face to face and executed individually to each patient.
The intervention will be delivered once per patient over approximately a 10 minute period
The intervention will be delivered at the Post Anaesthetic Care Unit on Level 8 of Auckland City Hospital (Auckland, New Zealand).

After the intervention has been delivered participants will be asked to complete a post infusion symptom questionnaire. Participants will also be contacted via telephone 3 days after their infusion to complete the same symptom questionnaire.
Intervention code [1] 296081 0
Behaviour
Comparator / control treatment
Participants (patients receiving IV iron infusion at Auckland City Hospital) who are randomised into the control group will receive a standard consultation for IV iron infusion (including side effect information).

The control consultation will be delivered by a Consultant Anaesthetist according to a standardised script.
The mode of delivery will be face to face and executed individually to each patient.
The control condition will be delivered once per patient over approximately a 10 minute period
The control condition will be delivered at the Post Anaesthetic Care Unit on Level 8 of Auckland City Hospital (Auckland, New Zealand).

After the control consultation has been delivered participants will be asked to complete a post infusion symptom questionnaire. Participants will also be contacted via telephone 3 days after their infusion to complete the same symptom questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 299829 0
Side effect reporting

Side effects will be assessed by self-report on a (study-designed) questionnaire. The participant will complete this questionnaire.
Timepoint [1] 299829 0
Immediately after IV Iron infusion
Secondary outcome [1] 328227 0
side effect reporting
Timepoint [1] 328227 0
3 days after IV iron infusion

Side effects will be assessed by self-report on a (study-designed) questionnaire. This questionnaire will be administered over telephone by the research assistant

Eligibility
Key inclusion criteria
To be eligible to participate in the trial, individuals must:
-be over 18 years of age
-be a patient referred to the Auckland City Hospital Anaesthesia Department for an IV iron infusion
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will not be eligible to participate in this study if they:
-are unable to give informed consent
-are unable to speak, write and read English

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment (by sealed opaque envelope) will be executed in this trial
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/11/2016
Actual
2/02/2017
Date of last participant enrolment
Anticipated
18/11/2017
Actual
12/10/2017
Date of last data collection
Anticipated
21/11/2017
Actual
15/10/2017
Sample size
Target
86
Accrual to date
Final
79
Recruitment outside Australia
Country [1] 8296 0
New Zealand
State/province [1] 8296 0
Auckland

Funding & Sponsors
Funding source category [1] 294650 0
University
Name [1] 294650 0
The University of Auckland
Country [1] 294650 0
New Zealand
Primary sponsor type
Individual
Name
Keith Petrie
Address
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country
New Zealand
Secondary sponsor category [1] 293512 0
Individual
Name [1] 293512 0
Anna Perera
Address [1] 293512 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland 1142
New Zealand
Country [1] 293512 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296089 0
University of Auckland Human Participants Ethics Committee
Ethics committee address [1] 296089 0
Research Office
Level 10, Building 620
49 Symonds Street,
Auckland 1010
New Zealand
Ethics committee country [1] 296089 0
New Zealand
Date submitted for ethics approval [1] 296089 0
10/10/2016
Approval date [1] 296089 0
25/11/2016
Ethics approval number [1] 296089 0
018222
Ethics committee name [2] 296090 0
Auckland District Health Board Research Review Committee
Ethics committee address [2] 296090 0
Level 14
Support Building
Auckland City Hospital
2 Park Rd,
Grafton,
Auckland 1023
NEW ZEALAND
Ethics committee country [2] 296090 0
New Zealand
Date submitted for ethics approval [2] 296090 0
10/10/2016
Approval date [2] 296090 0
19/12/2016
Ethics approval number [2] 296090 0
A+7376
Ethics committee name [3] 297035 0
Health and Disability Ethics Committees
Ethics committee address [3] 297035 0
Ministry of Health
Health and Disability Ethics Committees
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [3] 297035 0
New Zealand
Date submitted for ethics approval [3] 297035 0
13/10/2016
Approval date [3] 297035 0
05/12/2016
Ethics approval number [3] 297035 0
16/NTA/175

Summary
Brief summary
In patients with a low haemoglobin (Hb) for whom oral iron is considered unsuitable/has been unsuccessful, intravenous (IV) iron is used. Indications for IV iron infusion include malabsorption, continuing blood loss, poor adherence, or intolerance. Iron infusions are also sometimes offered in a preoperative setting to patients with iron deficiency anaemia.

At Auckland City Hospital, IV iron is administered as a single dose infusion taking approximately 15minutes. Immunological hypersensitivity reactions to IV iron are rare, however unwanted side effects (e.g. flushing, joint/muscle pains, headache and dizziness) are commonly reported by patients (Rampton et al., 2014).

In a healthcare context, the nocebo effect can be defined as the experience of symptoms, that are induced by the patient’s own negative expectations and/or by negative suggestions from clinical staff (Hauser, Hansen, & Enck, 2012). In a recent study we found that an explanation of the nocebo effect as a symptomatic experience influenced by negative expectations was effective in significantly reducing symptom reporting (Crichton & Petrie, 2015).

In this study we are investigating whether the nocebo effect has relevance to clinical medicine by examining whether changing standard verbal preparation information to include an explanation of the nocebo effect can reduce side effect reporting after IV iron infusion. Reductions in side effect reporting may have considerable clinical benefits in terms of reducing non-compliance with medications, and reduction of illness burden and distress.

Design: Potential participants will be sent study information with their appointment letter. On the day of their appointment they will be provided with verbal + written information on the project, and invited to participate by the research assistant.

Once written informed consent has been obtained, a baseline questionnaire (including symptom data) will be completed. Participants will be randomised into one of 2 groups; either
a) control: standardized preparation for IV iron infusion including side effect information, or
b) intervention: standardized preparation for IV iron including side effect information plus explanation of nocebo effect.

The control and intervention conditions will be delivered by a consultant anaesthetist (according to a standardised script for each condition). The nocebo intervention will outline the relationship between bodily sensations and individuals‘ attributions, expectations, and beliefs, and will offer an explanation of the nocebo phenomenon.

The research assistant (who will be blind to condition) will collect participant symptom data following IV iron infusion and at day 3 post-infusion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69498 0
Prof Keith Petrie
Address 69498 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 69498 0
New Zealand
Phone 69498 0
+64 9 373 7599 ext.86564
Fax 69498 0
Email 69498 0
[email protected]
Contact person for public queries
Name 69499 0
Keith Petrie
Address 69499 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 69499 0
New Zealand
Phone 69499 0
+64 9 373 7599 ext.86564
Fax 69499 0
Email 69499 0
[email protected]
Contact person for scientific queries
Name 69500 0
Keith Petrie
Address 69500 0
Auckland Hospital Support Building
Room 12.003, Level 12, 2 Park Road, Grafton Auckland 1023, New Zealand
Country 69500 0
New Zealand
Phone 69500 0
+64 9 373 7599 ext.86564
Fax 69500 0
Email 69500 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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