Informed Consent Form for Participants

This informed consent form is for PATIENTS who are currently admitted in FEU-NRMF, and who we are
inviting to participate in research. The title of our research project is Effects of Auditory Stimulation
on Anxiety in Pre-operative Patients
This research will be conducted by the following member:

PRINCIPAL INVESTIGATOR:
REFUERZO, Jirah Angelica M.

CO-INVESTIGATOR:
TRINA C. TAN, RN, MAN
BARTOLOME, Glaiza Rica V.
CABUS, Kristal G.
DELA ROSA, Josephine Colline R.
GARFIN, Katherine F.
This Informed Consent Form has two parts:

Information Sheet (to share information about the research with you)
Certificate of Consent (for signatures if you agree to take part)

You will be given a copy of the full Informed Consent Form

PART I: Information Sheet
Introduction
We are 3rd year students from section , currently taking up . We are doing research on the
EffectsofAuditoryStimulationonAnxietyinPreoperativePatients. We are going to give
you information and invite you to be part of this research. You do not have to decide today
whether or not you will participate in the research. Before you decide, you can talk to anyone
you feel comfortable with about the research.
There may be some words that you do not understand. Please ask us to stop as we go
through the information and we will take time to explain.
Purpose of the research
This study may aid in the provision of interventional measures as an act of relaxation
tool, in this case it could possibly minimize the anxiety level of pre-operative patients. The
study would likewise further improve and enhance the physical, mental, and emotional well-
being of individuals.
Type of Research Intervention
This research will involve the use of Autonomous Sensory Meridian Response to the
pre-operative patients with High Anxiety Level.
Participant selection
We are inviting all Patients who are in the Surgery Ward (4C) & Medicine Ward (5B)
of FEU-NRMF to participate in the research on the Effects of Auditory Stimulation on
Anxiety. We will choose the participants by using Convenience sampling method. Total
number of participants is 73.
Responsibilities of the Participant
As a participant, you are expected to observe and do the following:
1. Completely read the consent form and ask the Principal Investigator (PI) any
questions you may have. You should understand what will happen to you
during the study before you agree to participate.
2. Know the dates when your study participation starts and ends.
3. Carefully weigh the possible benefits (if any) and risks of being in the study.
4. Talk to the Principal Investigator (PI; the person in charge of the study) if you
want to stop being part of the research study.
5. Contact the PI with complaints or concerns about your participation in the
study.
6. Report to the PI immediately any and all problems you may be having with
the study procedure/device.
7. Fulfill the responsibilities of participation as described on the consent forms
unless you are stopping your participation in the study.
 8. Tell the PI or the person you are working with on the study when you have
received the compensation you were promised for participating in the study.
9. Ask for the results of the study, if you want them.
10. Keep a copy of the consent form for your records.Voluntary Participation
Your participation in this research is entirely voluntary. It is your choice whether to
participate or not. You may change your mind later and stop participating even if you agreed
earlier.
Duration
Participation will take approximately 60 minutes to complete.
Risk
There are minimal risks associated with participating in this study. It will not give you
any harm and is completely safe.
Benefits
At the end of the study, a thorough explanation of the research study and hypotheses
will be provided. We will describe the potential implications of the results both if our
hypotheses are supported and if they are disconfirmed. This research study maybe either
beneficial or not beneficial for you but your participation is likely to help us find the answer
to the research question.
Reimbursement
You will not be given any money or gifts to take part in the study. There is no money
involved in this research.
Confidentiality
With this research, something out of the ordinary is being done in your community. It
is possible that if others in the community are aware that you are participating, they may ask
you questions. We will not be sharing the identity of those participating in the research.
The information that we collect from this research project will be kept confidential.
Information about you that will be collected during the research will be put away and no-one
but the researchers will be able to see it. Any information about you will have a number on it
instead of your name. Only the researchers will know what your number is and we will lock
that information up with a lock and key. It will not be shared with or given to anyone except
Research and Development Office and the Ethics Review Committee.
Sharing the Results
You can access the result after conducting the study by sending it to you through e-
mail or text message before it will be published, in which other students of the course can
read it and can be used as reference by other researchers. However, confidential information
will not be made available to the public.
Right to Refuse or Withdraw
You do not have to take part in this research if you do not wish to do so. You may also
stop participating in the research at any time you choose. It is your choice and all of your
rights will still be respected.
Who to Contact
 If you have any questions you may ask us now or later, even after the study has
started. If you wish to ask questions later, you may contact: 09151387804
Ethics Review Board
The FEU-NRMF IERC Ethics Review Committee has approved the study, and may
be reached through the following contact for information regarding rights of study
participants, including grievances and complaints:
Milagros F. Neri, MD
Rm 218, 2nd floor, Institute of Medicine
Regalado Avenue near Dahlia Street, West Fairview, Quezon City 1118
Tel. No. +63 2 4270213 loc 1223
Email: feunrmf_ierc@yahoo.com

PART II: Certificate of Consent

I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it and any questions that I have asked have been answered to my
satisfaction. I consent voluntarily to participate as a participant in this research.
Print Name of Participant__________________

Signature of Participant ___________________

Date ___________________________
Day/month/year
Statement by the researcher/person taking consent
I have accurately read out the information sheet to the potential participant, and to the best of
my ability made sure that the participant understands that the following will be done:
1.
2.

I confirm that the participant will be given an opportunity to ask questions about the
study, and all the questions asked by the participant have been answered correctly and to the
best of my ability. I confirm that the individual has not been coerced into giving consent, and
the consent has been given freely and voluntarily.

A copy of this ICF has been provided to the participant.

Print Name of Researcher/person taking the consent________________________

Signature of Researcher /person taking the consent__________________________

Date ___________________________
Day/month/year