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Information sheet for passionflower study participants

Full information sheet (pdf 108KB)

This information sheet provides you with the background to the research and other important details about what is involved, so please read carefully before deciding whether or not to participate.

We are currently recruiting adults aged 18-45 years to take part in this research. As a volunteer, it is important for you to understand why we doing this research and what it will involve for you if you decide that you can participate. Please take time to read it carefully and discuss it with others if you wish. Please ask if anything is not clear, or if you would like more information.

Who pays for the study?

The study is fully funded by Douglas Pharmaceuticals Ltd.

Introducing the researchers

This study involves a team of researchers from Massey University. The principal investigator is Dr Pamela von Hurst, Associate professor of Human Nutrition. Dr. Hajar Mazahery, whose contact details are at the end of this information sheet, is the study manager. The psychologists on the team is Mr Warrick Wood and Lindy Thomas.

What is the purpose of this study?

Anxiety is very common in the general population. Herbal preparations have been widely used for the relief of mild symptoms of daily mental stress in various real-life situations. The herbal preparation that this study is going to investigate is passionflower. This research aims to investigate the immediate effect of passionflower on anxiety in response to an experimentally induced stress. There are small number of studies that examined the calming effects of passionflower. The information from these studies show that passionflower can affect the function of brain.

If shown to be effective, passionflower may be a powerful herbal remedy for improving the mild symptoms of anxiety in people’s daily life.

Do I qualify for the study?

You qualify to participate if you are aged 18-45 years and do not have serious medical conditions, are not pregnant or breastfeeding, and do not already use passionflower products.

Do I have to take part?

No, it is completely up to you to decide whether or not to take part. If you do decide to enter into the study you will be asked to sign a consent form. You are free to withdraw at any time without giving a reason.

If you decide to withdraw from the study, data obtained to date may be kept and used to contribute to the overall results. However, if you request that your data and other information relating to you are destroyed, we will ensure that this happens.

What do I have to do?

You will attend 3 appointments during the 4 week period (approximately 5 hours in total). All visits will be at Massey University, Albany.

Before you come, you will complete an online screening questionnaire to ensure that you meet the criteria for the study. At the first visit you will sign the consent form, then you will be familiarised with a computerised stress triggering program. At the second and third (final) visits you will complete two computerised stress triggering sessions in each day and will complete some questionnaires about the symptoms of anxiety before and after the computerised stress triggering sessions, and complete a safety checklist at these visits. You will also wear a wrist heart rate monitor throughout the testing sessions because we want also to see if passionflower has an effect on your heart rate.

At one of these visits you will use the study treatment before being exposed to the computerised stressor, and the other you will use the placebo. Neither you, nor the researchers will know which one you are having. This information is known only to someone unconnected with the trial. The procedures in these visits will be identical but you will use different treatments.

You will be randomised into a treatment order. You will be given different treatments at each visit that you will use before the commencement of second computerised stress triggering session. The treatments are in the form of a tasteless, colourless spray which you spray into your mouth.

Will I be reimbursed for my time?

You will receive $NZ100 vouchers in total (three visits) at the conclusion of the trial.

What are the possible risks and disadvantages of taking part?

There are no reported risks of taking passionflower at the dose we will be using. However, to ensure there is no risk, a safety checklist will be completed at each visit.

What are the advantages to taking part in the study?

As a participant in this study, you will have a number of assessments which are not usually available through standard care. You will receive a wealth of information about your anxiety states and how you respond to an experimental stressor. You will also be helping with research which, if successful, could make an important difference for many other people in coping with stressful life situations.

What will happen if anything goes wrong?

The risks involved in this study are very small. If you have any concerns during the study, you can discuss these with a member of the study team. If the concern is not resolved, you will then be referred to the study psychologist who is available in the campus.

If physical injury results from your participation in this study, you should visit a treatment provider to make a claim to ACC as soon as possible. ACC cover and entitlements are not automatic and your claim will be assessed by ACC in accordance with the Accident Compensation Act 2001. If your claim is accepted, ACC must inform you of your entitlements, and must help you access those entitlements. Entitlements may include, but not be limited to, treatment costs, travel costs for rehabilitation, loss of earnings, and/or lump sum for permanent impairment.

Compensation for mental trauma may also be included, but only if this is incurred as a result of physical injury.

If your ACC claim is not accepted you should immediately contact the researcher. The researcher will initiate processes to ensure you receive compensation equivalent to that to which you would have been entitled had ACC accepted your claim.

Will my taking part in the study be kept confidential?

Yes. All information collected about you during the study will be kept strictly confidential. Information will be entered into a protected database at Massey University. Massey University codes all data so that your name and address are kept separate from any other information about you.

Information collected about you will be kept strictly confidential and secure in locked filing cabinets and/or electronic files on computers with passwords and restricted access. Each participant is assigned a unique code which is used on all data collected. Only the specified research team will have access to personal identifying information.

Massey University maintains a central record of all research projects but this does not include any personal information about participants. We will store the data for 10 years, after which point it will be destroyed.

What will happen to the results?

At the end of the study, we will be in touch to let you know the results of the study. The overall results may be presented at scientific meetings or published in scientific journals to ensure that the wider community including health professionals know about the findings. The findings may also be featured in the media. A written report will also be provided to the funder, Douglas Pharmaceuticals Ltd. You will not be identified in any of these presentations or publications.

Who has reviewed the study?

This study has been approved by the Heath and Disability Ethics Committee (HDEC), Ref 19/CEN/157.

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