Stress and Elemental Reset Study
Researcher’s Name: Britt Toksvig Jorgensen, Phd. student in Natural Medicine
University: Quantum University, US
Protocol Title: The Effect of Elemental Resets on Stress and Stress Related Symptoms
Protocol ID: ElemRes001
You are invited to participate in a research study for a PhD project with the title: The Effect of Elemental Resets on Stress and Stress Related Symptoms. This document explains the study procedures, requirements, and risks and allows you to give your consent to participate.
Your participation is voluntary. If you do not want to continue to be in the study, you may stop at any time without penalty.
There is no sponsor and no financial incentive involved in this study.
WHY IS THIS STUDY BEING DONE?
The purpose of the study is to show that the self-care routine of Elemental Reset is effective in reducing stress levels and stress related symptoms in adults. The results will serve as input to the above mentioned Phd thesis.
HOW MANY PEOPLE WILL BE IN THE STUDY?
About approximately 30 adults will take part in this study.
WHO CAN PARTICIPATE?
The criteria for taking part in this study are as follows:
Between the age of 18 and 80
Live in the United States or the United Kingdom
Experiencing a considerable level of stress and/or stress related physical symptoms.
Fall in the relevant scoring band in this questionnaire [link to PROMIS10 and PSS-10]
Not suffering from any serious medical conditions.
Willing to commit to the required time, specified in the next section.
During the 3 month study period, you agree to keep other types of treatments to an absolute minimum (such as acupuncture, therapy, craniosacral therapy etc), and agree to not make notable changes to your existing self-care routines (medication, exercise, supplements, yoga, meditation, sleep patterns).
Let us know if you have questions about this on email@example.com.
WHAT AM I BEING ASKED TO DO?
The study has three phases - one per month:
Month One - no intervention
You will fill in a questionnaire twice; once at the start of the month and once at the end. Each questionnaire will take a few minutes to complete. Otherwise, no action is needed on your part.
Month Two - the intervention
The group of 70 adults will randomly be split 50/50 into two groups.
Group 1 - Be still: Every day of this month you will sit quietly with no distractions for 6 minutes using a timer (on your phone or other) to mark the end. You will track this daily practice on an online sheet. (We need you to keep this up at least 5 days a week in order to be able to use the results in our study. If practice falls under 5 days a week for more than two weeks, we are unable to use the results.)
Group 2 - Practicing the Elemental Reset techniques: At the start of the month, you will take part in a 2-3 hour Elemental Reset training (online), where you will learn the two techniques to apply daily for the duration of this month. An online weekly 30 minutes live and recorded refresher session is available but not mandatory. The daily practice takes approximately 6 minutes, and there will be audio guidance available. You will track this daily practice on an online sheet. (We need you to keep this up at least 5 days a week in order to be able to use the results in our study. If practice falls under 5 days a week for more than two weeks, we are unable to use the results.)
Both groups will fill in weekly online questionnaires tracking changes throughout this second month. You will receive email reminders each week.
Month Three - after the intervention
You can choose to continue with the exercises practiced during Month Two or not - entirely up to you. You will continue to refrain from engaging in other types of treatments or making changes to your self-care routines. The last questionnaire will be filled in at the end of Month Three, and that will be the end of your engagement with the study.
The same questionnaires will be used throughout the study; 10 questions about general health and wellbeing, and 10 questions related to stress.
HOW LONG WILL I BE IN THE STUDY?
This study will take approximately three months, the second month being the main month.
WHAT ARE THE BENEFITS OF PARTICIPATING IN THE STUDY?
It is expected that you will experience improvement in your health, wellbeing, and stress levels during the second month for Group 2. That may also be the case for Month Three. There could be some improvements for Group 1. However, no guarantee or promise can be made that you will receive any benefits from taking part in this study.
WHAT ARE THE RISKS OF PARTICIPATING IN THE STUDY?
The techniques used in the study are completely safe and non-invasive, and there are no foreseeable risks or discomforts for participants in the study.
It is also safe to participate during pregnancy, and through all types of medical interventions. However, pregnancy and medical interventions may change the results of the study, and we ask that you do not join if you are pregnant or in need of medical treatments.
The aim of the intervention is to bring more balance to the participants’ body and mind. In rare instances this can allow participants to get in touch with and feel an underlying tiredness that was hidden under adrenalin fuelled busyness/stress. Other temporary mild discomforts have been observed in extremely rare instances. Taking part in this study is not meant to replace any medical treatments or interventions that are recommended to you by your doctors for your condition.
WHAT ARE THE COSTS OF BEING IN THE STUDY?
There is no cost to you. There is a time commitment, but no financial commitment.
All records of participants will be kept private and secure, following all HIPAA-compliant regulations.
The Institutional Review Board that oversees academic research involving humans, including this study, will be granted direct access to all information upon request.
Be aware that your study records (which include your questionnaires, your signed consent form, and may include other information such as your name, address, phone number, etc) will be shared as needed for the study with the study team members. Your individual privacy will be maintained in all published and written data resulting from the study. The study results may be published, summarized on the BodyIntuitive.org website, or presented at various conferences, but your identity will not be disclosed.
If you do not authorize this use and sharing of your information by signing this form, you cannot participate in this research study.
You can cancel your authorization to use and share your information at any time by writing an email to Britt Jorgensen at firstname.lastname@example.org. If you cancel your authorization, you may not be able to continue in the study and the principal investigator and study staff will still be able to use and share your information that they have already collected. This authorization to use and share your information expires in 50 years.
WILL I BE COMPENSATED FOR PARTICIPATING IN THE STUDY?
You will receive no payment for taking part in this study. However, you are being offered participation in the Elemental Reset class and will gain access to the weekly Elemental Reset Refresh classes at no cost (value of USD61). Participants in Group 1 (the control group) will be offered to take part in the Elemental Reset class after the study is over free of charge.
WHAT IS THE BACKGROUND OF ELEMENTAL RESET?
Element Reset is a new self-care practice and is a type of mind-body medicine. Mind-body medicine is holistic healthcare that takes into account the effect of your mind (your stresses, emotions and mindsets) on the physical health of the body and vice versa. Elemental Reset combines Classical Chinese Medicine and 21st century science of health, including new scientific findings of the stress process, and the latest information on the nervous system and the effects of mental focus and mindset on the body and general health and wellbeing. The “parent” system to Elemental reset is called BodyIntuitive and is a professional level new mind-body medicine developed by Dr Laura Stuve, PhD, molecular biologist, and Dr Janet Galipo, Doctor of Oriental Medicine.
DISSERTATION MENTOR COMMITTEE APPROVAL
The study design and protocol of this research study has been reviewed and approved by The Dissertation Mentor Committee of Quantum University and it has been determined that this study meets the ethical obligations required by University policies. [NOT YET HAPPENED]
WHO DO I CONTACT IF I HAVE QUESTIONS?
Please contact Britt Jorgensen at email@example.com if you have any questions about the research study – either before signing up or during the study.
I have read this consent form and my questions have been answered. My signature below means that I:
Wish to participate in the study
Intend to remain in the study until the end. However, I am aware that I can remove myself from the study at any time without any penalty.
Commit to applying the techniques as mentioned above and to take time to fill in the questionnaires along the way to the best of my abilities.
Believe that the above commitment is realistic for me.
Meet the following criteria for participation:
Between the age of 18 and 80
Live in the United States, Canada, Ireland, the United Kingdom, New Zealand or Australia.
Experiencing a considerable level of stress and/or stress related physical or mental symptoms.
Score within the relevant band in this questionnaire
Not suffering from any serious medical condition
During the study (3 months) I agree to keep other types of treatments to an absolute minimum (such as acupuncture, therapy, craniosacral therapy etc) and will not make notable changes to my existing self-care routines (exercise, supplements, yoga, meditation, sleep patterns). Let us know if you have questions about this on firstname.lastname@example.org.
By signing below, I voluntarily agree to participate in this research program:
THIS IS THE DOCUMENT THAT YOU HAVE BEEN SIGNED IN GOOGLEFORM
It is a research study to evaluate the efficacy of the self-care routine, Elemental Resets, to decrease stress and stress related related symptoms.
Phase 1: No intervention. Questionnaire beginning and end.
Phase 2: Intervention: Two thirds of the participants will train in Elemental Reset (2h) and complete a daily practice of the Earth and Stress Mindset resets (approx. 6 min). The last third of participants will sit quietly with no distractions for 6 minutes a day. Weekly questionnaires for both groups.
Phase 3: Intervention optional - you can choose to continue your Elemental Reset routine. Questionnaire at the end.