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Pain Medicine 2013; 14: 621–627


Wiley Periodicals, Inc.

HEADACHE & FACIAL PAIN SECTION

Original Research Article


A Virtual Reality System Combined with
Biofeedback for Treating Pediatric Chronic
Headache—A Pilot Study

Shimon Shiri, PhD,*1 Uri Feintuch, PhD,†1 substantial need to develop other effective methods
Nilly Weiss, BA,** Alex Pustilnik, BA,* Tal Geffen, of treatment. Here we present the rationale, feasibil-
BA,¶ Barrie Kay, MD,‡,§ Zeev Meiner, MD,* and ity, and preliminary results of a pilot study applying
Itai Berger, MD§ a novel system, combining virtual reality and bio-
feedback, aimed as an abortive treatment of pediat-
*Department of Physical Medicine and Rehabilitation, ric chronic headache.
Hadassah Hebrew University Medical Center,
Jerusalem, Israel Design. A prospective single-arm open-label, pilot
study. Ten children attending an outpatient pediatric
† neurology clinic were treated by the proposed
School of Occupational Therapy, Hebrew University,
system. Participants practiced relaxation with
Jerusalem, Israel biofeedback and learned to associate successful
relaxation with positive pain-free virtual images of

Pediatric Neurology Unit, Hadassah-Hebrew themselves.
University Medical Center, Jerusalem, Israel
Results. Nine patients completed the 10-session
§
Neuro-Cognitive Center, Pediatric Division, intervention. Ratings of pain, daily functioning, and
Hadassah-Hebrew University Medical Center, quality of life improved significantly at 1 and at 3
months posttreatment. Most patients reported
Jerusalem, Israel
applying their newly acquired relaxation and
imagery skills to relieve headache outside the lab.

Department of Psychology, The Hebrew University,
Jerusalem, Israel Conclusion. This novel system, combining bio-
feedback and virtual reality, is feasible for pedi-
**Department of Psychology, Ben-Gurion University of atric use. Randomized controlled studies in larger
the Negev, Beer-Sheva, Israel populations are needed in order to determine
the utility of the system in reducing headache,
Reprint requests to: Shimon Shiri, PhD, Department of improving daily functioning, and elevating quality
Physical and Medical Rehabilitation, Hadassah of life.
University Hospital—Mount Scopus, Jerusalem 91120,
Israel. Tel: 972-2-5610626; Fax: 972-2-5844885; Key Words. Headache; Virtual Reality; Biofeed-
E-mail: shimonshiri@hadassah.org.il. back; Mirror Neurons; Self-Face Recognition

1
Equal contributors.
Introduction

Abstract Headache is one of the most common chronic distressing


health conditions among children, and considered the
Objective. Pediatric headache is highly widespread most frequent neurological symptom and commonest
and is associated with distress and reduced quality manifestation of pain in childhood [1,2]. Headache, espe-
of life. Pharmacological treatment of chronic head- cially in adolescents, is associated with other physical
ache in children has been only partially effective and psychiatric comorbidities [1–3]. In population-based
and, as in medication-overuse headache, can some- studies, it was mentioned that almost 60% of children are
times be counterproductive. Therefore, there is a prone to headache, of variable frequency [4].

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Shiri et al.

Headache treatment for children and adolescents common principles with models promoting the use of
includes both pharmacologic and non-pharmacologic virtual mirrors, as presented in a recent preliminary
measures [5,6]. However, medication-overuse headache, study [20].
resulting from the overuse of analgesics, triptans, or other
acute headache compounds, is highly prevalent and has In this study, we present the rationale, feasibility, and pre-
in itself severe effects on quality of life [7]. Therefore, liminary results of applying an innovative system, com-
non-pharmacologic interventions are encouraged and fre- bining VR and BF, aimed as an abortive treatment for
quently used among children including lifestyle adjust- pediatric chronic headache. The system has been
ments (regular sleep, dietary adjustment, or regular designed in light of learning models of chronic pain, in
exercise program), stress management, and other behav- which the role of operant conditioning in chronic pain is
ioral therapies [8]. highlighted [21,22]. In the present context, operating the
system allows patients to associate between their ability to
Biofeedback (BF) and guided imagery (GI) have been iden- relax (as indicated by reductions of their galvanic skin
tified as competent non-pharmacologic paradigms for response [GSR]) with headache decline (as illustrated by
headache treatment [9]. BF appears to be effective in virtual images). As in our previous study [23], a self-
reduction of tension headache and migraine and in reduc- face viewing interface was adopted to allow robust
ing anxiety, depression, and medication overuse [10–12]. neural activity.
GI has been reported as an efficient treatment for head-
ache in the general population [13] and particularly with We hypothesized that the learning process of associating
children [13,14]. Further, GI has been associated with between their ability to relax and viewing themselves in a
increased brain plasticity, which is essential to enhance headache-free state would enhance the participating chil-
therapeutic progress [15,16]. dren’s ability to better cope with their headache and its
consequences [24].
In this study, we present a novel virtual reality (VR) system,
which simultaneously employs both BF and positive Methods
images, similar to images suggested in GI. VR applications
have been applied successfully to treat acute pain by Participants
creating various pain-free virtual environments [17,18].
These applications have traditionally been used to distract The study was designed as a prospective single-
from acute pain during painful medical procedures. arm open-label, pilot study. The study was conducted
Recent studies suggest that chronic pain, too, is a prom- in an outpatient pediatric neurology clinic at a tertiary
ising candidate for VR interventions [19]. care university hospital. Pharmacotherapy continued
during the study period; there were no new preventive
We hypothesized that VR can serve as an efficient and medications started during the study period. The chil-
perhaps more potent replacement to GI, as it can provide dren suffered from chronic headache but were otherwise
therapeutic images even to individuals with difficulty in healthy. Their detailed characteristics are presented
following imagery suggestions [18]. Our approach shares in Table 1.

Table 1 Demographic characteristics

Symptoms Treatment
Duration Duration
Participant Diagnosis Age (Years) Gender (Years) Medications (Months)

1 CTH 16.5 F 5.5 AC; NS 60


2 CTH 12 M 1 AC 11
3 CTH 12 F 2 AC; NS 12
4 CTH 10 M 3 AC 30
5 CM 17 M 5 AC; NS; T 36
6 CM 17.5 F 0.5 AC; NS; AM* 6
7 CM 13.5 M 1 AC 12
8 CM 13 M 3 AC; NS 24
9 CM 10.5 M 0.25 — —
10 CM 12 M 3 AC 18

* Dose and duration of treatment using amitriptyline was 10 mg for 1 month.


F = female; M = male; CTH = chronic tension headache; CM = chronic migraine; AC = acetaminophen/paracetamol;
NS = nonsteroidal anti-inflammatory drug; T = triptans; AM = amitriptyline.

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A Virtual Reality Biofeedback System

Headache diagnosis was established by a certified pedi- integrated with a graphical representation of the pain,
atric neurologist based on the International Classification which the patient found appropriate. Thus, as can
of Headache Disorders criteria [25]. After an interview be seen in Figure 1, each patient’s set of self images
with the child and parents with specific attention being represented a full spectrum of emotional states, from agony
paid to headache and treatment, a neurological exami- to happiness.
nation, and further evaluation, including ophthalmic
examination by a certified ophthalmologist and brain During each session, patients were instructed to gaze at
imaging where clinically indicated were performed and the screen and try to relax, as it displays a virtual rep-
found to be normal. Six of the children fulfilled the criteria resentation of the patients and their pain. Success-
for migraine headache and four children fulfilled the cri- ful relaxation, as indicated by GSR reductions, led
teria for tension-type headache. Nine out of 10 children to gradual fading of headache representations, while
were treated (previous to their inclusion in the study) by changing color and size. The algorithm was designed so
at least one medication. Data are specified in patients were led by their virtual self from a painful state
Table 1. to a relaxed pain-free state. At the beginning of each
session, the first 10 seconds were used to gather GSR
Exclusion criteria were intellectual disability, other chronic data and create a baseline. Then four thresholds were
condition, and primary psychiatric diagnosis (e.g., set to distinguish between the five emotional ranges,
depression, anxiety, autistic spectrum disorders, and psy- each associated with a representative facial picture. The
chosis). Children diagnosed with learning disabilities distance between the thresholds was set by the thera-
and/or attention/deficit-hyperactivity disorders were not pist and adjusted according to the patient’s progress. In
excluded from the study, yet all participants study in order to achieve a smooth transition between the five
regular school classes. Ethical approval was obtained phases, we implemented an approach of overlapping
from the Internal Review Board (Helsinki Committee) of ranges. This was done in order to avoid unstable
Hadassah-Hebrew University Medical Center. All children jumps between two pictures when the GSR signal fluc-
agreed to participate in the study and all parents signed an tuates around the threshold value. Thus, once crossing
informed consent form. the threshold and moving from one range to the adja-
cent one and changing the picture presented on the
Intervention screen, the GSR level was actually set to be in the
center of the new range, thus requiring a substantial
The system consists of a desktop computer and the increase or decrease of the signal in order to cross the
ProComp Infiniti system by Thought Technology (Montreal, next threshold.
Quebec, Canada). The latter gathers physiological data
using two electrodes tracking the patient’s GSR, which Protocol
was used as a BF device because of its sensitivity for
headache [26]. This signal is processed online by our The patients attended an introductory meeting where the
system, which provides a visual feedback based on the treatment and its rationale were explained. They, as well as
patient’s emotional state. The visual presentation is based their guardian, signed a consent form and had their picture
on a set of images acquired during the introductory taken in various emotional states (either mimicked at the
meeting. During this session, patients had their picture lab or photographed by the parent in the natural setting at
taken with different facial expressions such as “happy,” home), to which they attached graphical images repre-
“neutral,” “agony” etc. Each of these pictures was then senting their pain at each state.

Figure 1 Patient’s set of self-images.

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In the following 10 sessions, patients were connected to Headache


the GSR electrodes and instructed simply to watch their
image on the screen and try to relax. These sessions Patients were asked to grade on a VAS (0–10):
lasted up to 30 minutes depending on the patient’s per-
formance. In the latter stages of the intervention, patients 1. To what extent does your headache limit your
were instructed to try and implement their new relaxation daily function?
skill whenever experiencing a headache. 2. On average, how severe was your headache during the
previous week?
Outcome Measures
As can be seen in Table 2, the values have declined from
the pretest to the posttest to the final follow-up. Wilcoxon
The patient’s pain was measured using visual analog scale
paired sample test has produced a significant improve-
(VAS) to report the average pain level over the past week,
ment before and after the intervention for Question 1
as well as the level of functional limitation imposed by the
(P < 0.05) and approached significance for Question 2
pain attacks. Quality of life was assessed using the Pedi-
(P = 0.068). When conducting the Friedman nonparamet-
atric Quality of Life Inventory (PedsQL™) developed by Dr.
ric test for related samples, this improvement seems to
James W. Varni et al. [27]. This questionnaire contains 23
persist over a longer period of time, beyond the duration of
Likert scale questions, evaluating various aspects (e.g.,
the intervention for both VAS ratings (P < 0.01 and
physical, social, and emotional) of the patient’s quality of
P < 0.05, respectively).
life. The patients were also asked to rate their satisfaction
following operating the system and were asked to report
Quality of Life
freely about their experience during the treatment.
When examining the data of the PedsQL, collected at the
Data were collected prior to the intervention, immediately
different time points, one can observe an improvement in
following its completion, 1 month later, and at 3 months
the quality of life, measured before and after the interven-
follow-up.
tion. This change, from 48.67 to 39.78, was found to be
significant by the Wilcoxon test (P < 0.01). Here, too, the
Statistical Analysis improvement was stable beyond the treatment period and
remained throughout the follow-up period, as indicated by
Due to the small sample size and the low measurement the Freidman test (P < 0.01). It should be noted that in all
scale, we have chosen to analyze the data using nonpara- outcome measures, no difference were found between
metric tests. The Pretest-Posttest measures were ana- the migraine and tension-type headache patients. Given
lyzed using the Wilcoxon signed rank test for paired the small sample size, the ability to detect differences
sample. Analysis of the four time-points data (pretest, between these two small samples is limited.
posttest, 1 month, 3 months) was conducted using the
Freidman test. User Satisfaction and Feedback

The patients were asked to rate on a Likert scale (1–5)


Results
whether the treatment was helpful and whether they
would recommend it to a friend suffering from a similar
Participants
condition. They were also asked to freely report whether
and how the treatment had influenced their daily life and
Mean age of participants was 13.4 ⫾ 2.7 years and the
whether they used the relaxation technique they were
mean duration of reported headache 29.1 ⫾ 21.8
taught, and if so, to describe an example. As indicated in
months. Average headache frequency reported as 17
Table 2 the user feedback tended to be positive.
days per month, average duration per headache attack
reported as 19 hours (before taking medications),
When reviewing the patient data, it is evident that there are
the frequency of acetaminophen, nonsteroidal anti-
two subpopulations. Seven of the patients demonstrated
inflammatory drug, or triptan usage reported as 16
a high level of satisfaction, rating their experience as 4 or
days per month. Taking headache-abortive medications
5, whereas two patients did not feel the treatment helped
at this frequency decreased the headache duration
them, rating it as 1 or 2. Yet, it is of interest to note, upon
to an average of 6 hours, but did not change heada-
examining the PedsQL scores, that even these two
che frequency.
patients have shown at least 20% improvement from their
pretest score to their posttest and follow-up scores. This
Adherence effect was similar to that of the other patients.

All the patients, except for one, completed all the inter- Finally, most patients reported incidents where they expe-
vention sessions and cooperated during the whole rienced a headache and harnessed their new relaxation
process without difficulties. One patient, a 12-year-old skills to relieve it. Being a free report, we cannot know the
male, withdrew after six sessions, as he felt that the exact approach employed by the patients. Some reports
progress was not satisfactory. state laconically that “I tried to relax and I succeeded; the

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A Virtual Reality Biofeedback System

headache stopped,” or “Many times when I wake up with

Four Measurements
P Value across All
a headache, I concentrate and it decreases.” On the other
hand, many of the reports refer explicitly to components of
the intervention: “I imagined I was seeing the pictures of
myself in the treatment, and the headache reduced, and
then after a few minutes it went away,” or “I sat in front of

0.001

0.004

0.003
a mirror and drove away the headache.”



Discussion

38.94 (10.58)*
Posttreatment

1.63 (1.92)*

2.06 (2.08)*

4.1 (0.7)*
4.9 (0.2)*
In this work, we present the rationale, feasibility, and
3 Months

results of a pilot study operating a novel system, combin-


ing VR and BF to relieve chronic headache and its nega-
tive consequences among children. Following this
intervention, patients reported significant declines in head-
ache severity, improvements in daily functioning, and in
38.78 (10.17)*
Posttreatment

1.29 (1.98)*

2.23 (2.98)*

quality of life. These reports were consistent immediately,


3.8 (1.3)*
3.9 (1.6)*

1 month, and 3 months post intervention both in migraine


1 Month

and tension-type headache.

The system has been found to be feasible, and the par-


ticipants reported no negative side effects. Moreover, the
(Post-Pre)

ratings indicated that the children were mostly satisfied


P Value

with their experience operating the system and found this


0.069

0.015

0.006

treatment method as helpful and valuable to the degree



that most of them would recommend it to others with a


similar condition.
39.78 (10.24)*
2.22 (2.99)*

3.11 (2.63)*

4.1 (1.3)*
4.1 (1.6)*

Operating the system served as an additional treatment as


most participants were treated prior to their inclusion in
Posttest

the study by medications for an average of 29 months


without significant improvement. One could deduce that
the decline in their headache, the improvement in func-
tioning, and the elevations in QOL may have been the
48.67 (10.83)*
5.00 (3.08)*

4.28 (2.92)*

result of this intervention. Yet, the design of the study does


not allow us to draw conclusions as to the effectiveness of
the system, and further randomized controlled studies are
Pretest

necessary to establish this as a treatment for chronic



pediatric headache.

The system has been designed in congruence with learn-


23–115
Scale*

0–10

0–10

ing models of chronic pain, stressing the significance of


1–5
1–5

operant conditioning in promoting and exacerbating


chronic pain behaviors [21,22] Traditionally, operant
models of chronic pain have highlighted the role of positive
To what extent does your headache limit your

On average, how severe was your headache

To what extent would you recommend it to a

social reinforcements in pain behaviors such as facial pain


friend suffering from a similar problem?

expressions and complaints of pain and of negative rein-


Do you feel the treatment helped you?

forcements such as avoiding undesired or fear-provoking


activities [21]. In the present context, the behavior that has
Outcome measures

been enhanced is the patients’ ability to reach relaxation


as indicated by the system. A positive reinforcement for
during the previous week?

this behavior is the gradual presentation of a patient’s


image as pain free and happy [24]. A negative reinforce-
ment that increases the probability of successful relaxation
* Standard deviation.

is the gradual minimization of the headache representation


attached to the patient’s own face image presented on a
daily function

computer screen [24]. These reinforcements had been


presented immediately after reductions in GSR, as high
Table 2

PedsQL

immediacy increases the effectiveness of learning [28,29].


Other possible reinforcements of reducing GSR are the
relaxation and calmness and sense of control over bodily

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