Download as pdf or txt
Download as pdf or txt
You are on page 1of 9

Research Consent Form Participant ID________________

Improving social engagement using biofeedback-linked serious game

Principal Investigator:
Dr. Herbert, , Assistant Professor, College of Medicine and Health Sciences,;

Researcher’s Statement:
We are asking you to be in a research study. The purpose of this consent form is to give you the
information you will need to help you decide whether to be in the study or not. Please read the
form carefully. You may ask questions about the purpose of the research, what we would ask you
to do, the possible risks and benefits, your rights as a volunteer, and anything else about the
research or this form that is not clear. When we have answered all your questions, you can decide
if you want to be in the study or not. This process is called “informed consent.” We will give you a
softcopy of this form for your records.

Purpose of the Study

The research aims to study how effective it is to use biofeedback connected games particularly
focusing on Geometry Dash, a game on tablets to boost interaction. By combining the Heartmath
biofeedback program with the Geometry Dash gaming platform and monitoring EEG, heart rate,
respiration and electrodermal activity (EDA. The study will look into the harmony between two
players involved in the game. Positioned next to each other. This inquiry adds to the research on
social interaction through interactive gaming offering insights into how biofeedback linked
interactive gaming influences adaptive reactions to stress in a social setting.

Study Procedures
If you wish to proceed as a research participant, we ask you to keep external influences to a
minimum and not take up a new lifestyle intervention / habit such as a new exercise routine or
trying yoga for the first time while being in the study. During the study you will be required to
first:
1) Sign the Informed Consent Form.
2) Complete the Current Health Status Questionnaire and the DASS-21 to ensure your suitability
for inclusion into the study and the questionnaires.
3) Complete the Game Experience Questionnaire to measure your experience of media enjoyment
4) An information session will be provided after you sign the required forms, we will explain the
biofeedback of serious games technique to you, and the requirements of the research, and you
can ask questions.
5) You will be assigned a code. The link between the subjects’ identity and code will be
confidential. All data will be linked to the code rather than the subjects’ personal information.
6) Your physiological signals (brainwaves (EEG), heart rate, PPG, temperature, respiration, and
sweating) will be recorded for 10 minutes at the beginning until the end of the training
session.
7) You will undertake 1 session for 10 minutes.

For the data collection, these are the following steps that will be followed:
1. Each group of 2 subjects will undertake 1 session lasting approximately 10 minutes at Khalifa
University
2. Throughout the training session all subjects will have their physiological features recorded
that includes brainwaves (EEG), heart rate, PPG, temperature, respiration, and sweating.
3. First the physiological features will be recorded when the subjects are facing a wall or window.
4. Second, the physiological features will be recorded when the subjects are playing but not
looking at each other.
5. Last, the physiological features will be recorded when the subjects are playing and facing each
other at the same time.

Recording Devices
For the recording of physiological signals such as heart rate, breathing rate, and PPG
(photoplethysmogram) signal, we will be using the Bitalino (Plux) hardware and software. This
consists of a strip across your stomach to measure respiration and three Velcro strips attached to
your fingers to measure pulse rate, temperature, and electrodermal activity (EDA). Brainwave
activity is measured by sensors placed on the ear lobes and the forehead. The Bitalino (Plux)
system will also record the PPG (photoplethysmogram) signal. This signal, measured by the finger
sensors, provides valuable information about blood volume changes and can be used to assess
cardiovascular health.

Figure 1. Bitalino sensor kit

Figure 2. Typical sensor placement for Nexus-10 system.

In the present study, we are intended to use EEG, respiration, Blood Volume Pulse (BVP),
Electrodermal Activity (EDA), and temperature as sensors. All sensors are placed non-invasively
to collect the data.
Risk, Stress, or Discomfort

Some people may experience anxiety, we recommend that you need to contact your general
practitioner to follow up. This is unlikely to happen while playing games on tablets.
A sensor on your earlobes, forehead, and around your fingers may be uncomfortable for the first
few minutes of the session. The recording sensors on the fingers which are attached to Velcro
straps may cause some itchiness and we can alleviate this by covering the Velcro band with tissue.
The stomach strap should not be too tight, it should fit snugly to record your breathing rate.
Finally one sensor will be placed on the center on top of your head, which requires a small
amount of paste to be placed on the sensor so it will hold. The paste is removed from your scalp
using an alcohol wipe and does not cause any irritation.
This research is completely voluntary, and you can stop anytime if you do not wish to continue.
We would like to thank you for your involvement in this rather challenging research project.

Benefits from the Study

In this study, people will participate as volunteers and will not receive any reward for doing this
experiment. However, it’s well known how physiological health is important in our overall health
and wellbeing. And, focusing during playing video games can put you under stress and pressure,
especially when there are other players around you. Therefore, participants will have the
opportunity to observe the mental and biological changes during playing video games. Also, they
will be more able to recognise these changes whenever they play video games.
Your voluntary involvement in this study will help the researchers understand more about the
efficiency of using biofeedback / synchronization in monitoring the changes in your body and
brain during playing a game on a tablet. It will also provide some insights about how eye contact
and playing a video game with someone else playing around will influence the changes in your
brain (synchronization). Understanding the effects of a session of biofeedback, synchronization
and eye contact ,during playing video games, in physical and mental parameters is important for
bringing this training to use in our community.

Confidentiality of Research Information


The study is confidential. You will be only identified by a code rather than any personal
information. All information linking your identity to the collected data is stored confidentially in a
separate computer folder only known to the PI and password protected. The constructed
database will only show the coded data.

The aim is to publish the results from this study in international/national scientific/engineering
journals/conferences/meetings, but, the results will only represent the whole population of data,
and no individual information will be made available to the public.
All the information you provide will be confidential. However, if we learn that you intend to harm
yourself or others, we must report that to the authorities.

Other Information
You may decide not to participate once the project has started. In this case you are free to
withdraw from this study at any time without penalty or loss of benefits to which you are
otherwise entitled.
Herbert Jelinek

Printed name of study staff obtaining consent Signature Date

___________________________________________________________________________________
Printed name of Subject Signature Date
DASS21 Name: Date:

Please read each statement and circle a number 0, 1, 2 or 3 which indicates how much the statement
applied to you over the past week. There are no right or wrong answers. Do not spend too much
time on any statement.

The rating scale is as follows:

0 Did not apply to me at all


1 Applied to me to some degree, or some of the time
2 Applied to me to a considerable degree or a good part of time
3 Applied to me very much or most of the time

1 (s) I found it hard to wind down 0 1 2 3

2 (a) I was aware of dryness of my mouth 0 1 2 3

3 (d) I couldn’t seem to experience any positive feeling at all 0 1 2 3

I experienced breathing difficulty (e.g. excessively rapid breathing,


4 (a) 0 1 2 3
breathlessness in the absence of physical exertion)

5 (d) I found it difficult to work up the initiative to do things 0 1 2 3

6 (s) I tended to over-react to situations 0 1 2 3

7 (a) I experienced trembling (e.g. in the hands) 0 1 2 3

8 (s) I felt that I was using a lot of nervous energy 0 1 2 3

I was worried about situations in which I might panic and make a fool
9 (a) 0 1 2 3
of myself

10 (d) I felt that I had nothing to look forward to 0 1 2 3

11 (s) I found myself getting agitated 0 1 2 3

12 (s) I found it difficult to relax 0 1 2 3

13 (d) I felt down-hearted and blue 0 1 2 3

I was intolerant of anything that kept me from getting on with what I


14 (s) 0 1 2 3
was doing

15 (a) I felt I was close to panic 0 1 2 3

16 (d) I was unable to become enthusiastic about anything 0 1 2 3

17 (d) I felt I wasn’t worth much as a person 0 1 2 3

18 (s) I felt that I was rather touchy 0 1 2 3

I was aware of the action of my heart in the absence of physical


19 (a) 0 1 2 3
exertion (e.g. sense of heart rate increase, heart missing a beat)

20 (a) I felt scared without any good reason 0 1 2 3

21 (d) I felt that life was meaningless 0 1 2 3


DASS-21 Scoring Instructions

The DASS-21 should not be used to replace a face to face clinical interview. If you are experiencing significant
emotional difficulties you should contact your GP for a referral to a qualified professional.

Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to
measure the emotional states of depression, anxiety and stress.

Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The depression
scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement,
anhedonia and inertia. The anxiety scale assesses autonomic arousal, skeletal muscle effects, situational
anxiety, and subjective experience of anxious affect. The stress scale is sensitive to levels of chronic non-
specific arousal. It assesses difficulty relaxing, nervous arousal, and being easily upset / agitated, irritable /
over-reactive and impatient. Scores for depression, anxiety and stress are calculated by summing the scores
for the relevant items.

The DASS-21 is based on a dimensional rather than a categorical conception of psychological disorder. The
assumption on which the DASS-21 development was based (and which was confirmed by the research data) is
that the differences between the depression, anxiety and the stress experienced by normal subjects and
clinical populations are essentially differences of degree. The DASS-21 therefore has no direct implications for
the allocation of patients to discrete diagnostic categories postulated in classificatory systems such as the
DSM and ICD.

Recommended cut-off scores for conventional severity labels (normal, moderate, severe) are as follows:

NB Scores on the DASS-21 will need to be multiplied by 2 to calculate the final score.

Depression Anxiety Stress

Normal 0-9 0-7 0-14

Mild 10-13 8-9 15-18

Moderate 14-20 10-14 19-25

Severe 21-27 15-19 26-33

Extremely Severe 28+ 20+ 34+

nd
Lovibond, S.H. & Lovibond, P.F. (1995). Manual for the Depression Anxiety & Stress Scales. (2 Ed.)Sydney: Psychology Foundation.
Participant Code

Clinical History
❒ Male ❒ Female Age ………………. (yrs)

Have you been diagnosed with diabetes? ❒ Yes ❒ No


❒ Type I ❒ Type 2

Length of time since diagnosis …………… (yrs) Do you take insulin? ❒ Yes ❒ No
Have you been diagnosed with or experienced any of the following?
❒ Balance-related illnesses yrs ❒ Cognitive issues yrs ❒ PTSD yrs
❒ Heart problems yrs ❒ Muscle problems yrs ❒ Schizophrenia yrs

❒ Neurological disorders yrs ❒ Epilepsy yrs ❒ Anxiety yrs


❒ Heart attack yrs ❒ Reflux yrs ❒ Skin diseases yrs
❒ Stroke yrs ❒ Trauma disorder yrs ❒ Parkinson’s Dis. yrs
❒ Chest pain yrs ❒ Depression yrs ❒ Skeletal diseases.
❒ Pain in legs yrs ❒ ADHD yrs ❒ Other genetic diseases.
❒ Dizziness yrs
** If you have any special needs or serious health problems not
❒ Palpitations yrs mentioned above, PLEASE write them in the box below.
❒ Other cardiac symptoms

Lifestyle and Family History Questions:

▪ Do you smoke more than 5 cigarettes per day? ❒ Yes ❒ No


▪ Do you consume more than 2-3 glasses of alcohol per day? ❒ Yes ❒ No
▪ Are you currently taking medication for High Blood Pressure? ❒ Yes ❒ No
▪ Do you have a family history of diabetes? ❒ Yes ❒ No
▪ Do you have a family history of cardiovascular disease? ❒ Yes ❒ No
▪ Do you have a family history of depression disease? ❒ Yes ❒ No
▪ Do you have a family history of PTSD? ❒ Yes ❒ No
▪ Do you have a family history of schizophrenia? ❒ Yes ❒ No
▪ Do you have a family history of anxiety? ❒ Yes ❒ No
▪ Do you have a family history of neurological disease? ❒ Yes ❒ No
▪ Have you ever had a serious musculoskeletal injury? ❒ Yes ❒ No
▪ Are you currently following a weight loss diet? ❒ Yes ❒ No

How many hours of exercise would you do in a typical week?

Duration (hrs): ❒ none ❒ 1 ❒2 ❒3 ❒4 ❒5 ❒6 ❒7 ❒8 ❒9 ❒ 10 ❒ 10+

Intensity (all applicable): ❒ low ❒ moderate ❒ high


Participant Code

Medications

PHARMACEUTICAL and / or NATURAL MEDICATIONS

Medication name Reason for Prescription Other information


FUGA The fun of gaming: Measuring the human experience of media enjoyment

Appendix 1: Game Experience Questionnaire (GEQ)

Please indicate how you felt while playing the game for each of the items,
on the following scale:
not at all slightly moderately fairly extremely
0 1 2 3 4
< > < > < > < > < >

1 I felt content
2 I felt skilful
3 I was interested in the game's story
4 I could laugh about it
5 I felt completely absorbed
6 I felt happy
7 I felt tense
8 I felt that I was learning
9 I felt restless
10 I thought about other things
11 I found it tiresome
12 I felt strong
13 I thought it was hard
14 It was aesthetically pleasing
15 I forgot everything around me
16 I felt good
17 I was good at it
18 I felt bored
19 I felt successful
20 I felt imaginative
21 I felt that I could explore things
22 I enjoyed it
23 I was fast at reaching the game's targets
24 I felt annoyed
25 I was distracted
26 I felt stimulated
27 I felt irritable
28 I lost track of time
29 I felt challenged
30 I found it impressive
31 I was deeply concentrated in the game
32 I felt frustrated

page 41

You might also like