Manuscript type: Research article

Title: A STUDY ON EVALUATION OF RISK FACTORS, QUALITY OF LIFE AND PREVALENCE

OF PRIMARY HEADACHE DISORDERS: MIGRAINE, TENSION TYPE HEADACHE AND
CLUSTER HEADACHE.

Running title: A study on the association between risk factors, quality of life and the prevalence of
primary headache disorders among youth.

Names of the authors:

1. Daniel Ezra Philip - Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, PES
University, Bangalore, Karnataka 560050
ORCID: 0000-0003-1024-540X
Email: danielephilip@gmail.com
2. Asima Kubra - Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, PES
University, Bangalore, Karnataka 560050
ORCID: 0000-0002-2911-3610
Email: asimakubra97@gmail.com
3. Aditi Singh - Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, PES
University, Bangalore, Karnataka 560050
ORCID: 0000-0002-4820-9861
Email: aditisingh0404@gmail.com
4. Dr.Vineela Nekenti. - Assistant professor, Department of Pharmacy Practice, Faculty of
Pharmaceutical Sciences, PES University, Bangalore, Karnataka 560050
ORCID: 0000-0003-0347-2102
Email: vineelan@pes.edu
5. Dr.R. Srinivasan – Professor and Head, Department of Pharmacy Practice, Faculty of
Pharmaceutical Sciences, PES University, Bangalore, Karnataka 560050
ORCID: 0000-0002-1731-5901
Email: srinivasanr@pes.edu
Corresponding author: -Daniel Ezra Philip - Department of Pharmacy Practice, Faculty of Pharmaceutical
Sciences, PES University, Bangalore, Karnataka 560050

ORCID: 0000-0003-1024-540X

Email: danielephilip@gmail.com

Postal Address:

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences (Formerly, PES College of

Pharmacy), PES University, Hanumanthanagar, Bangalore - 560050, Karnataka, India.
The Editor

Indian Journal of Community Medicine

Subject: Submission of manuscript for publication

Dear Sir,

I would like to submit the manuscript entitled “A STUDY ON EVALUATION OF RISK FACTORS,
QUALITY OF LIFE AND PREVALENCE OF PRIMARY HEADACHE DISORDERS: MIGRAINE,
TENSION TYPE HEADACHE AND CLUSTER HEADACHE” by Daniel Ezra Philip, Asima Kubra, Aditi
Singh, Dr.Vineela Nekenti and Dr.R. Srinivasan for your kind consideration and publishing this as an
original article in your esteemed journal.

On behalf of all the contributors I will act and guarantor and will correspond with the journal from this
point onward.

We hereby transfer, assign, or otherwise convey all copyright ownership, including any and all rights
incidental thereto, exclusively to the journal, in the event that such work is published by the journal.

Thanking you,

Yours sincerely

Daniel Ezra Philip

TITLE:
A STUDY ON EVALUATION OF RISK FACTORS, QUALITY OF LIFE AND
PREVALENCE OF PRIMARY HEADACHE DISORDERS: MIGRAINE, TENSION
TYPE HEADACHE AND CLUSTER HEADACHE.
ABSTRACT:
Objective: Headache disorders are a common nervous system disorder that affects many people
worldwide. Enhancing awareness about this in youth can help in addressing the consequences of
the disorder that may extend to adulthood. This study aimed to determine the prevalence and
associated factors of headache disorders in the population.
Methods: The students of the institution were approached batch-wise and were briefed about the
study and its purpose. Informed consent was obtained from all the students who were willing to
participate in the study. The enrolled subjects were provided with the link of the self-
administered questionnaire, which comprised of 4 sections, section 1, 2 and 3 comprised of
HARDSHIP questionnaire while section 4 comprised of WHOQOL 8 questionnaire.
Results: The prevalence of headache disorders in youth was found to be 48.78% using a
HARDSHIP. Annual household income and sleep duration was found to have a statistically
significant association with the prevalence of headache disorders (*P-value:<0.00001). The
prevalence of Migraine, TTH and CTH were found to be 19.76%, 23.17% and 5.61%
respectively.
Conclusion: This study reports the prevalence of headache disorders among students in the age
group 16-25, in the university students, and also the magnitude of the associations between
various factors and primary headache. The prevalence of TTH was significantly higher than
Migraine (1.2 times) and CH (nearly 4.2 times) in the study population. The study found that the
following factors were significantly associated with primary headache disorders female gender,
Annual family income, sleep duration, intake of caffeinated beverages.
KEYWORDS:
Headache, prevalence, HARDSHIP
INTRODUCTION
Headache disorders impact approximately 1.7-4% of the global populace each month, ranking as
the second leading disability cause.[1]. However, their common occurrence often results in
undiagnosed cases, as individuals routinely overlook their significance, undermining the need for
proper medical attention.
The headache disorders are classified into primary and secondary type based on their criteria.
The current global prevalence of primary headache is 47%; migraine headache, 10%; tension-
type headache, 38%; and chronic daily headache, 3% [1]. Primary headache consists of migraine,
tension type headache, and cluster headache - constitute nearly 98% of all the headache types; of
which the most common type is tension type headache disorder[1]. Cluster headache is
uncommon but it is also often misdiagnosed or mismanaged.
The primary headache disorders can be easily distinguished based on the duration of the pain.
Classification of these is based on an untreated headache episode that lasts for less or more than
4 hours. Majorly, the short duration headaches belong to 'trigeminal autonomic cephalalgia’, of
which cluster headache is most prevalent. The long duration headache can be either migraine or
TTH.
Headache represents a multifactorial disorder that lowers quality of life, and has negative effect
on school or college life and also promotes absenteeism. Irena Jurišić .et. al [2] study says that
gender, smoking, drunkenness and back pain elevates headaches.
The World Health Organization (WHO) reports that migraines are more prevalent in women than
in men, exhibiting a 2:1 ratio [3]. Tension-Type Headaches (TTH), which typically begin during
teenage years, affect three women for every two men. Conversely, Cluster Headaches (CH) are
quite rare, affecting fewer than 1 in 1000 adults, with six men affected for each woman. [3]
MATERIALS AND METHODS
Design and setting
A community based cross-sectional study was carried out for a period of 6 months, from
September 2020 to February 2021. The study included students belonging to the age group of 16-
25 years. The study obtained IEC approval. Furthermore, we secured authorization to use the
HARDSHIP questionnaire through email correspondence with Mr. Timothy J. Steiner.
For subjects to be included in the study, they had to meet the inclusion criteria of being within 16
-25 years of age and attending either pre-university or a degree college. Exclusion criteria were
subjects below 16 years of age, subjects above 25 years of age, and subjects not attending pre-
university or Degree College. Data collection was performed using the HARDSHIP
Questionnaire, and a self-made proforma of socio-demographic factors, the WHOQOL scale was
also incorporated into the same. The questionnaires were distributed to the students via a Google
Forms link. The data collection procedure was clarified for the participants, with a strong
emphasis on maintaining confidentiality throughout the process. Informed consent was obtained
from the participants.
Measures
Headache-Attributed Restriction, Disability, Social Handicap and Impaired Participation
(HARDSHIP) questionnaire[11] is an instrument developed for demographic enquiry, diagnostic
questions based on ICHD-3 beta criteria. The self-administered questionnaire, which comprised
of 4 sections, section 1, 2 and 3 comprised of HARDSHIP questionnaire while section 4
comprised of WHOQOL 8 questionnaire. HARDSHIP questionnaire consists of questions related
to subject screening for headache, episodes of daily headache, diagnosis of headache, besides
WHOQOL 8 comprises of questions to assess the quality of life among the study subjects.
Socio-demographic factors: A self-designed proforma which included questions regarding socio-
demographic factors such as age, gender, religion, annual income, duration of sleep, intake of
caffeinated beverages, menstrual headaches and BMI based questions were incorporated.
Sample size and statistical analysis
The sample size was determined using the standard normal variate at 5% type I error. The
expected proportion was set as 63.9%, obtained from a previous study conducted by Girish N
Rao[13] , and absolute error was set as 5%. The sample size was found to be 355 or more.

The data was entered into MS Excel and then analyzed using Epi info software. Socio-
demographic factors were described using descriptive statistics, including frequencies and
proportions. The association between these factors and headache disorders was tested using a
Chi-square test. Statistical significance was determined by a P-value below 0.05.
RESULTS
A total of 430 responses were collected from the study participants in the age group of 16-25
years. The responses of 20 subjects were excluded due to incomplete inputs. Hence the data
obtained from the 410 responses was available for the final analysis. In the current study, the
mean age of study participants was 21.4±2.2. The response rate of the study subjects was found
to be 95.34%.
Table 1: Demographic details of the study population

Age
16-20 111 (27.07%)
21-25 299 (72.92%)

Gender
Male 167
Female 243

BMI
Underweight 33
Normal 263
Overweight 92
Obese 22

Prevalence of headache disorders

Based on the “HARDSHIP QUESTIONNAIRE” the prevalence of headache disorders was
found to be 48.78% (n=200). The current study was mainly focused on the primary headache
disorders such as Migraine, TTH and CTH. The prevalence of Migraine, TTH and CTH were
found to be 19.76%, 23.17% and 5.61% respectively.
Table 2: Prevalence of subtypes of headache disorder based on gender

Subtypes Male Female Total

Frequency Percentage Frequency Percentage
(n) (%) (n) (%)
 Migraine 30 40 45 60 75
TTH 33 37.89 55 62.10 88
CH 4 22.23 14 77.78 18

Factors associated with headache disorders

The association between the hypothesized risk factors & the prevalence of headache disorders
was studied using the chi-square test (Table 3). The hypothesized risk factors such as family
income, sleep duration, intake of caffeinated beverages, were found to have statistically
significant association with headache disorders, at p < 0.05.
Table 3: Chi Square test results to determine association between postulated risk factors
(independent variables) and headache disorders

SL. Risk factors and Presence of Absence of Total χ2 p-value

NO Category headache headache n
disorders n disorders n
(%) (%)

GENDER
1. Female 125 (51.44%) 118 (48.5%) 243 1.68 0.193

Male 75 (44.9%) 92 (55.08%) 167

2. ANNUAL INCOME

>10 Lakhs 11 (22.90%) 37 (77.08%) 48 122.64 <0.00001*

8-10 lakhs 7 (28%) 18 (72%) 25

5-8 Lakhs 29 (20.86%) 109 (78.41%) 139

3-5 Lakhs 76 (76.7%) 23 (23%) 99

< 2 Lakhs 77 (77%) 23 (23%) 100

3. SLEEP DURATION

2-4 hours 64 (90.14%) 7 (9.80%) 71 122.35 <0.00001*

4-6 hours 73 (68.86%) 33 (31.13%) 106

6-8 hours 37 (20.6%) 142 (79.3%) 179

>8 hours 26 (48.14%) 28 (51.85%) 54

4. INTAKE OF CAFFEINATED BEVERAGES

>3 servings a day 38 (82.60%) 8 (17.39%) 46 84.653 <0.00001*

 3 servings a day 64 (77.10%) 19 (22.89%) 83

2 servings a day 25 (27.17%) 67 (72.82%) 92

1 serving in a day 27 (40.9%) 39 (59.04%) 66

>3 times in a week 8 (47.05%) 9 (52.94%) 17

twice in a week 18 (62%) 11 (37%) 29

None 20 (25.08%) 57 (74.02%) 77

5. BMI

Obesity 12 (54.54%) 10 (45.45%) 22 5.62 0.131

Overweight 53 (57.60%) 39 (42.39%) 92

Normal 123 (46.76%) 140 (53.23%) 263

Underweight 12 (36.36%) 21 (63.63%) 33

6. MENSTRUAL CYCLE

Right before menses 13 (56.52%) 10 (43.47%) 23 1.38 0.70

First 3 days of menses 8 (61.53%) 5 (38.46%) 13

between two menses 5 (62.5%) 3(37.5%) 8

No effect of menses 99 (49.74%) 100 (50.25%) 199

*Statistically significant at p<0.05

Table 4: Association of independent variables with headache disorders among
participants

Sl. Category Presence of headache Absence of headache RR Value

No. disorders n (%) disorders n (%)

1. Gender

Female 125 (51.44%) 118 (48.55%) Ref

Male 75 (44.91%) 92 (55.08%) 0.87

2. Annual Income
 >10 Lakhs 11 (22.90%) 37 (77.08%) Ref.

8-10 lakhs 7(28%) 18 (72%) 1.22*

5-8 Lakhs 29 (20.86%) 109 (78.41%) 1.33*

3-5 Lakhs 76 (76%) 23 (23%) 3.34*

< 2 Lakhs 77 (77%) 23 (23%) 3.36*

3. Sleep duration

>8 hours 26 (48.14%) 28 (51.85%) Ref.

2-4 hours 64 (90.14%) 7 (9.80%) 1.88*

4-6 hours 73 (68.86%) 33 (31.13%) 1.43*

6-8 hours 37 (20.60%) 142 (79.30%) 0.42

4. Intake of caffeinated beverages

None 20 (25.08%) 57 (74.02%) Ref.

>3 servings a day 38 (82.60%) 8 (17.39%) 3.18*

3 servings a day 64 (77.10%) 19 (22.89%) 2.96*

2 servings a day 25 (27.17%) 67 (72.82%) 1.04*

1 serving in a day 27 (40.90%) 39 (59.04%) 1.57*

>3 times in a week 8 (47.05%) 9 (52.94%) 1.81*

twice in a week 18 (62%) 11 (37%) 2.38*

5. BMI

Normal 123 (46.76%) 140 (53.23%) Ref.

Obesity 12 (54.54%) 10 (45.45%) 1.16*

overweight 53 (57.60%) 39 (42.39%) 1.23*

Underweight 12 (36.36%) 21 (63.63%) 0.77

6. Menstrual cycle
 No effect of menses 99 (49.74%) 100 (50.25%) Ref.

Right before menses 13 (56.52%) 10 (43.47%) 1.13*

First 3 days of menses 8 (61.53%) 5 (38.46%) 1.23*

Between two menses 5 (62.5%) 3 (37.5%) 1.25*

*Relative Risk > 1: Positive Association between Independent Variable & headache disorder.

Table 5: Chi Square test and relative risk results to determine association between Quality
of life (WHOQOL - 8) and Headache Disorders (in healthy subjects vs. subjects with
headache disorder).

SL.N QOL Presence of Absence of n χ2 p-value OR value

O headache headache
disorders disorders
n(%) n(%)

1. High 128 (42.38%) 174 (57.61%) 302 ref

2. Moderate 69 (66.34%) 35 (33.65%) 104 18.89 0.000079 1.56*

3. Low 3 (75%) 1 (25%) 4 1.7*

High = > 66%, moderate = 33-66%, low = < 33%

DISCUSSION
The current study reported high prevalence of primary headache disorders among the Indian
youth. This outcome of the study was consistent with the results of Yared Zenebe et al. [4] study
in Ethiopia, Gender- and age-adjusted 1-year prevalence of headache was 72.8% in adolescents
and children. However, studies by Mahdieh Momayyezi et al. [5] & Jasem Yousef et al. [6],
reported low prevalence of Migraine and TTH in Iran and Kuwait respectively. The prevalence
of migraine and TTH was the highest in Ethopia with 38.6% and 19.9% respectively, as
compared to Iran and Kuwait, where the prevalence of migraine & TTH was 6% & 4.9% and
10.9% & 6.2% respectively. The studies performed by Qianyun Xie et al. [8] ,Mauro E Jurno et al.
[7]
, on CH in China and Brazil showed 1.70% and 0.0414% respectively, which were
comparatively lesser than the prevalence rate observed (CH 4.39%) in the current study. While
the participants enrolled in the current study were between 16-25 years of age, the average age of
participants in other studies differed considerably.
The current study showed that the factors such as annual income, sleep duration, intake of
caffeinated beverages. (p <= 0.05)
In the current study, incomes were classified into 5 groups : >10 lakhs, 10-8 lakhs, 5-8 lakhs, 3-5
lakhs, <2 lakhs. [Table 3 and 7] A study conducted by Walter F et al. [9], observed that the
occurrence of migraine was more in subjects with lower household annual income. The current
study showed a statistically significant association between the low household income and the
prevalence of headache disorders at p<0.05. [Table 3 and 7] Individuals’ health condition can be
influenced by their economic conditions.

Kelman and Rains [10] observed that nearly half the people with migraine had at least intermittent
signs of insomnia, 38% recorded sleeping fewer than 6 hours per night, and 50% reported sleep
disruptions that induced migraine. In the current study the duration of sleep was divided into: 2-
4hours, 4-6 hours, 6-8 hours, >8 hours [Table 3 and Table 4]. There was a statistically significant
association between the sleep pattern of the study subjects and the prevalence of headache
disorders, [Table 3 and 7] Hence with the good sleep habits; one may reduce both the number
and intensity of headaches.
Abu Bakar N et al. [12] conducted a systematic review on 80 papers which analysed Health related
quality of life (HRQol) of major primary headache disorders like migraine, TTH and CH. He
observed that Primary headache disorders significantly diminish quality of life, with degree of
impairment being dependent on headache type. There is a high prevalence of psychological
comorbidity associated with headache disorders, which affects quality of life.
The impact of quality of life of the study population was assessed by WHOQOL-8, which was a
part of HARDSHIP [11] questionnaire. This is depicted in Table 10. After its assessment it was
found that Quality of life was statistically significant at p<0.05, those study subjects with
moderate and low quality of life showed positive association with occurrence of headache
disorders.
CONCLUSION
The current study reports the prevalence of headache disorders among students in the age group
16-25, in the university students, and also the magnitude of the associations between various
factors and primary headache. The prevalence of TTH was significantly higher than Migraine
(1.2 times) and CH (nearly 4.2 times) in the study population. The current study found that the
postulated risk factors such as annual family income, sleep duration, intake of caffeinated
beverages had a statistically significant association with primary headache disorders. Quality of
life also showed to have a statistical significance with primary headache disorders. The early
diagnosis and management of headache disorders can help reduce or eliminate the consequences
of headache disorders and prevent any suppression in quality of life.

LIMITATIONS

1) The use of self-report might cause an arbitrary error due to recall bias.
2) Misunderstanding the questions and unwillingness to report stigmatizing symptoms &
knowledge of the diagnosis increases the possibility that respondents with primary headache
disorders give overly pessimistic appraisals of their symptoms, which affects the result of our
study.
3) Insufficient sample size due to the inability to acquire all the necessary data when students
didn’t provide all the information within the survey.
REFERENCES
1. Hagen K, Jensen R, et al. The global burden of headache: a documentation of headache
prevalence and disability worldwide. Cephalalgia. 2007;27(3):193-210.
2. Jurišić I, Pavić Šimetin I, Dikanović M, Cvitković A. Headaches in adolescents -
frequency, risk factors and other health complaints: A cross-sectional study in Croatia.
Acta Clin Croat. 2018;57(4):613-617.
3. World Health Organization. Headache disorders. 2016.
4. Zewde YZ, Zebenigus M, Demissie H, et al. The prevalence of headache disorders in
children and adolescents in Ethiopia: a schools-based study. J Headache Pain.
2020;21,108.
5. Momayyezi M, Fallahzadeh H, Momayyezi M. Prevalence of Migraine and Tension-
Type Headache in Yazd, Iran. Zahedan J Res Med Sci. 2015;17(4).
6. Al-Hashel JY, Ahmed SF, Alroughani R. Prevalence and Burden of Primary Headache
Disorders in Kuwaiti Children and Adolescents: A Community Based Study. Front
Neurol. 2019;10.
7. Jurno ME, Pereira BSR, Fonseca FAS, et al. Epidemiologic study of cluster headache
prevalence in a medium-size city in Brazil. Arq Neuropsiquiatr. 2018;76(7):467-472.
8. Xie Q, Huang Q, Wang J, et al. Clinical features of cluster headache: an outpatient clinic
study from China. Pain Med. 2013;14(6):802-7.
9. Stewart WF, Roy J, Lipton RB. Migraine prevalence, socioeconomic status, and social
causation. Neurology. 2013;81(11):948-55.
10. Kelman L, Rains J. Headache and sleep: examination of sleep patterns and complaints in
a large clinical sample of migraineurs. Headache. 2005;45:904–910.
11. Steiner TJ, Gururaj G, Andrée C, et al. Diagnosis, prevalence estimation and burden
measurement in population surveys of headache: presenting the HARDSHIP
questionnaire. J Headache Pain. 2014;15(1):3.
12. Abu Bakar N, Tanprawate S, Lambru G, et al. Quality of life in primary headache
disorders: A review. Cephalalgia. 2015.
13. Kulkarni GB, Rao GN, Gururaj G, et al. Headache disorders and public ill-health in
India: prevalence estimates in Karnataka State. J Headache Pain. 2015;16,67.
Reply to the reviewers’ comments

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