Flyer: I love the picture and contact information! I would add some bullets of what grounding
therapy is or what patients will need to do.
You can do bullet points.
Self
Consent form: missing study title
Missing attachments:
·
All
Education materials and teaching plans
·
All
Pre and Post-test (if using this)
·
Letter
of approval from site (stating that they do not have an IRB at your facility,
or IRB approval from your facility if they do require this)
·
Any
published tools that you are using for measurement (copy of tool)
·
Approval
to use any published tool that is not of the public domain (this can be an
email from the publisher)
·
Student
ACRP human subjects certificate
·
Chair/Professor’s
ACRP/CITI human subjects certificate (I will send)
IRB Application:
Pg 1
Missing project title. Remove your E-mail
Pg 2
Add my information as
co-investigator-1
Page 3
Check yes
Pg 5
Missing signature
Pg 6
Missing duration of
study. Give yourself wiggle room- 6
months
Missing study population
Missing number of
participants
Pg 7
Make font larger in
Background so we can see it
Spell out all acronyms the
first time- example GAD
This academic project’s
goals are to advance evidence-based knowledge and offer justification for using
alternative therapies to treat GAD in the senior population. There is a need to
investigate alternative strategies that can supplement or improve the current
techniques, even though standard
psychotherapy has been extensively researched and proven to be a successful
treatment for many mental health issues (delete this), including GAD (Lewis et al., 2022). This study seeks to
give empirical data and add to the knowledge of innovative therapies that might
be helpful for elderly people by comparing the effectiveness of daily grounding
(earthing) in treating GAD.
This study aims to find
potentially helpful and cost-effective techniques for enhancing mental health
outcomes in this vulnerable group by contrasting the efficacy of daily
grounding (earthing) to conventional psychotherapy. Daily grounding, also known
as “earthing,” is physical contact with the Earth’s surface, such as
when you walk barefoot on grass or sand. It has been proposed that this
practice has physiological benefits for lowering stress and promoting mental
well-being. I don’t think you will be able to compare
these two groups. I believe I have made
several comments regarding this. My
concern is your grounding patients most likely are in therapy and you can’t
ethically pull them out. You can either
compare to baseline or compare psychotherapy to psychotherapy combined with
grounding. And the psychotherapy
techniques must be identical in this case to prevent extraneous variables.
Page 8
Participant Informed
Consent: Participants will receive comprehensive information about the study’s
objectives, procedures, potential risks, and benefits. How will this take
place? How will you recruit patients?
Referral? Flyers only? Phone call?
Baseline Assessments:
Baseline assessments will include the collection of demographic information,
medical history, and current lifestyle habits using standardized surveys. Which surveys will be
used? These need to be attached and you
can refer to them as “Appendix A” etc
Uniform Group Activities:
All participants will be placed in the same group with consistent activities
related to nutrition, diet, activity, or a combination of these factors. You will group them
physically or in the data?
Pre and Post-Intervention
Tests: Physiological
measurements, including height, weight, waist circumference, and body
composition, will be systematically documented at predetermined intervals. Are these recorded in the beginning? You need to be very clear what variables you
are collecting and have the surveys attached.
Intervention: The
intervention phase will involve either daily grounding therapy or baseline
measures, depending on the assigned group. How are you assigning groups? Are these new patients? Are they already in
psychoterhapy?
Data Collection: Data
will be collected before and after the 10-week intervention period.
Data Analysis:
Quantitative data collected through surveys and physiological measurements will
be subjected to statistical analysis using appropriate techniques such as
t-tests, ANOVA, and regression analysis.
Where is the tool you were
going to use to measure anxiety? I don’t
see that listed here?
Tasks (pg 8):
Initial Assessment (1-2 hours): Includes a review of
medical history, a physical exam, and anthropometric measures. Conducted in a
clinical setting by skilled research professionals. How will this be
funded? Will you be doing this? What specific data is collected? Need to reference the surveys Where will this occur?
7-day assessment of dietary intake- is this needed for your study? This doesn’t seem relevant?
Participants keep a thorough food journal for a week. is this needed for your study? This doesn’t seem relevant?
Keep track of all food and drink consumption, serving
sizes, and cooking techniques. is this needed for
your study? This doesn’t seem relevant?
Evaluations of the Follow-up (30 minutes to 1 hour): To
take place following the intervention period and reflect the first assessment. Where will this take place? Who will do this?
The tasks should just list the surveys and expectations
of what the subjects will do. The
details should be further outlined in the methodology section. You seem to be collecting a lot of data that
has nothing to do with your study? Your
PICOT in the class have discussed the impact of grounding on anxiety. You can gather demographic measures, but the
data needed is regarding anxiety. Where
is your measuring tool you discussed for measuring anxiety? The diet and physiological measures etc are
not needed for this study.
Recruitment
procedures (pg 8)
Potential
participants will be located through a variety of means, such as
recommendations, neighborhood announcements, web advertisements, and outreach
to senior organizations– you will need to attach all
advertisements and outreach scripts.
This needs to be described in detail in the methodology. Are these facilities associated with the
research site?
The
full study disclosure and permission forms will be delivered to eligible
participants electronically or by mail, with the option of in-person sessions
for those who prefer them. In person consent or
grounding teaching? Strict
privacy safeguards will be put in place, including participant anonymity and
data security.
You are not using deception- so no debriefing is
necessary
Page
9
You checked yes and no on photographs but did not check
anything under video tapes?
You must collect identifiers in order to compare the pre
and post of your anxiety screening tool. Unless you expect the subjects to
correctly remember their number? You
will need a coding system and have this locked behind TWO locks ie password
protected computer and locked drawer etc
Page
11
It
is advised to apply password security methods for your files and save them on a
secure computer or make use of cloud storage services that offer encryption
features in order to ensure the integrity of the data.
Create
and use surveys or questionnaires to collect primary information from people.
Paper-based forms must be stored in a designated, secure location with access
limited to those who have been given permission in order to ensure their
security.
I would specifically write what you are going to do. Shouldn’t be general
Page 12 Risks and benefits
You need to check over 65
Page 13
1. To ensure their informed consent, all participants will get change to
receive thorough information about
the research’s objectives, procedures, potential risks, and benefits prior to
participating in the study. Participants will be given enough time to ask
questions and give written consent, but only if they fully understand and voluntarily
agree to participate. How will you determine if someone is capable of informed
consent? Any concerns with this?
2. Ethical Approval: An institutional review board (IRB)
will thoroughly assess the study project’s ethical considerations. To protect
the welfare and rights of the study subjects, the Institutional Review Board
(IRB) is in charge of ensuring that the research is conducted in compliance
with ethical standards.
3. Maintenance of Confidentiality and Anonymity: The study
will guarantee the highest level of subject data during its duration. The
removal or anonymization of identifying information will be conducted, and the
access to personal data will be restricted solely to approved researchers. Change to the primary
investigator
Page 14
Participants will be given enough time to ask questions and
give written consent, but only if they fully understand and voluntarily
agree to participate. How do you determine if they fully understand?
Benefits for society- section needs
editing and clarification of the comparison.
I would delete “Despite minor concerns like discomfort or inconvenience,
the advantages of better mental health for society outweigh them” You should not be causing discomfort for the
subjects?