Music for the Management of Pain in Primary Dysmenorrhea in Students of the School of Medicine and Health Sciences From the Universidad Del Rosario
Phase: NA
Conditions: Pain, Menstrual, Primary Dysmenorrhea
Sponsor: Universidad del Rosario

*** Disclaimer: This document is a direct translation of the original protocol of the 
research proposal titled “El uso de la música para el manejo del dolor por dismenorrea 
primaria en estudiantes de la Escuela de Medicina y Ciencias de la Salud de la 
Universidad del Rosario”. The protocol was submitted to Universidad del Rosario´s 
Institutional Review Board in Spanish, as per of their requirements. The research 
protocol was approved by the IRB on July 18, 2017 at the Capital District of Bogotá, 
Colombia under the identification number DVN021-1-099-CEI856. Footnotes have 
been added in parts that had changes. Principal Investigator Juan S. Martin-
Saavedra, MD, did the translation of the document. Communications with the IRB 
and the approved informed consent used were not translated but if required please 
request to the principal investigator. *** 
 
GENERAL INFORMATION 
 
ORIGINAL TITLE (in Spanish): El uso de la música para el manejo del dolor por 
dismenorrea primaria en estudiantes de la Escuela de Medicina y Ciencias de la Salud 
de la Universidad del Rosario 
 
TITLE: Music listening for the management of pain in primary dysmenorrhea of 
students from the School of Medicine and Health Sciences, Universidad del Rosario 
 
PRINCIPAL INVESTIGATORS:  
Angela María Ruiz-Sternberg, MD, MSc. 
 Full Professor –School of Medicine and Health Sciences, Universidad del 
Rosario 
 Email: angela.ruiz@urosario.edu.co 
 Phone: 2970200 ext. 3422 
 Mailing address: Cr 24 63C-69 
Juan Sebastián Martin Saavedra MD. 
 Research Assistant (Mandatory Social Service Physician) 
 Email: jss.martin.jsm@gmail.com/ juans.martin@urosario.edu.co 
 Phone: 3002230897 
 Mailing address: Cr 24 63C-69 
 
RESEARCH GROUP: Clinical Research Group 
ORGANIZATION: School of Medicine and Health Sciences, Universidad del Rosario 
 
SETTING: Bogotá D.C., Colombia 
 
RESEARCY TYPE: Clinical Trial 
LAST EDITED: April 20, 2017 
 
 
SUMMARY 
 
Primary dysmenorrhea is described as a crampy-like pain in the lower abdomen that 
occurs during menses. It is estimated as one of the most common pathologies in women 
of reproductive age. Nonetheless, it has been suggested as under-diagnosed and under-
treated. Currently, the first line of management is the NSAIDs (Non-Steroidal Anti-
inflammatory Drugs) and the OCC (Oral Contraceptives). Nevertheless, the effectiveness 

 
is below 100%, and contraindications, as well as adverse effects, exist. Music 
effectiveness in pain relief has been reported in different clinical context and is 
recommended as a complementary therapy for pain management. However, music has 
not been studied for pain relief in primary dysmenorrhea. The following project pretend 
to study the efficacy of music for pain relief in primary dysmenorrhea, in students from 
the School of Medicine and Health Sciences, Universidad del Rosario, Capital District of 
Bogotá, Colombia. This document proposes the conduction for a single blinded and 
randomized clinical trial. Participants would be allocated through computer 
randomization one of two groups. The experimental group would be exposed to a song 
composed by one of the investigators, and it will be compared to a silence group used as 
control. It is expected to identify a significant reduction in pain perception in primary 
dysmenorrhea in the experimental group compared to the control group. 
 
 
PROJECT DESCRIPTION 
 
 
1. Research question conception and justification 
 
Dysmenorrhea comes from the Greek words dys “hard or painful”, men “month or 
monthly”, and rrhea “discharge” (1). Dysmenorrhea is defined as painful menses, and is 
characterized by a crampy-like pain that locates in the lower abdomen. It is classified as 
primary or secondary dysmenorrhea (1-4). Primary dysmenorrhea may be defined as 
colic, or spasm, located at the lower abdomen during menses, that is not associated to any 
pelvic or uterine pathology (2, 4). The onset usually occurs during the first 24 months 
after menarche (1, 2). The pain begins some hours prior or after menses (1, 4), and it lasts 
between 8 to 72 hours, with the most sever symptoms during the first or second day of 
menses (1, 2). 
 
Primary dysmenorrhea is considered the most common gynecologic condition in women 
of reproductive age (2-4). Some studies have reported that dysmenorrhea has a negative 
impact of quality of life (2, 3), and is considered the first cause for school and work 
absence in these women (2, 4). 
 
First line of management is Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). Second 
line of management is Oral Contraceptives (OCC) or other forms of hormonal 
contraception (2-7). Nonetheless, efficacy of the treatment with NSAIDs and OCC is no 
under 100% (2, 4). Other types of treatment include: transcutaneous electrical nerve 
stimulation, nitroglycerin patch, and laparoscopic sacral and uterine nerve ablation (2, 4). 
Other described treatments include: acupuncture, local heat, herbal beverages, massage, 
music listening, and others (1). 
 
The International Association for the Study of Pain (IASP), defines pain as “An 
unpleasant sensory and emotional experience associated with actual or potential tissue 
damage, or described in terms of such damage”, and includes primary dysmenorrhea in 
the classification of chronic pain syndromes (8). Pain is a complex experience (9), and its 
complexity has motivated the study of complementary treatments for pain management 
such as music (10-19). However, to date, no studies on the effectiveness of music for pain 
relief in primary dysmenorrhea have been conducted.  
  

 
 
 Research questions:  
 
a) Could music improve the overall painful experience in primary 
dysmenorrhea?  
 
b) Could music be used as an alternative therapy for pain relief and reduce 
the analgesic requirements in primary dysmenorrhea?  
 
c) Could music, unknown to the patient, be able to effectively relieve acute 
pain in primary dysmenorrhea?  
 
 
 Project justification 
 
About 116 million of people suffer from any form of chronic pain (a prevalence that 
surpasses the prevalence of diabetes, cancer, and hypertension together) according to the 
Institute of Medicine (IOM) of the United States. Chronic pain is considered a disease 
and an epidemic. Additionally, 60% of the visits to the emergency department are for 
acute pain, and of those, 74% are of moderate to sever pain (9). 
  
Since 1994, the IASP included dysmenorrhea as a chronic pain syndrome (8), and as a 
pelvic chronic pain syndrome (2, 20). Firs line of management for primary dysmenorrhea 
includes NSAIDs and OCC (2, 4, 20). Due to the little knowledge on these drugs and the 
disease, the inadequate formulation, the self-formulation, the adverse effects, and the 
contraindications; primary dysmenorrhea is currently under treated with an efficacy 
below 100% (2, 4). This has increased the use of non-pharmacological treatments as 
complementary therapies (1, 2, 4). However, better knowledge on this forms of treatment 
are needed, which supports the conduction of proper clinical trials. 
 
 Background 
 
Prevalence of Dysmenorrhea in College and High School 
 
Prevalence of dysmenorrhea varies a lot in the literature (2, 4, 21). Several studies of the 
prevalence and characteristics of dysmenorrhea among College students (1, 3, 22-24) and 
High School students exist (25, 26). Prevalence in non-college students has been reported 
of 72% in Japan (26) and 85% in Hispanic population of the USA (25). The prevalence 
in college students has been reported of 62,4% in Mexico (22); 45,3-87,7% in Turkey (1, 
3, 23); and 86.4% in Jordan (24).  
 
In Colombia, Yañez et al. reported that the prevalence in students from Medicine and 
Psychology, from Universidad del Rosario during the year 2010. Mean age was 19.3 years 
(SD 2.8), and the results reported a prevalence of 73% (n=92 of 126), from which, 96.7% 
reported the pain was of 3 or more on a VAS (severe to moderate). Additionally, 91.3% 
of the students used a drug, of which, 66.7% were self-formulated (27). This study shows 
the high prevalence of this pathology in the target population of this research. 
 
Currently, dysmenorrhea is diagnosed clinically (5-7) but the definition changes among 
different authors (2), which explains the variability in the prevalence. Other important 

 
issues that may explain this are the life style among women. Different life styles seem to 
affect the symptoms in dysmenorrhea (2, 5-7). For example, several authors agree that 
exercise is associated with a smaller prevalence (1, 4, 7). Also, a diet rich in Omega-3 
seems to be associated to a smaller prevalence (4, 7). Additionally, some identified risk 
factors are tobacco use, and family history of dysmenorrhea among other (2, 4-7). 
 
Physiopathology 
 
The most accepted physiopathology of dysmenorrhea involves the over production of 
arachidonic acid derivate, especially prostaglandins (PG) (2, 4, 8, 28). Increase in PG of 
patients with dysmenorrhea have been reported, mainly PGE2 and PGF2α have been 
associated with it (2, 4, 28). Other molecules, such as Leukotrienes LT-C4/D4 and LTE4 
(4, 24), nitric oxide (4), and vasopressin (2, 4), seem to be associated. Nonetheless, the 
better understood are the PG, and direct association between concentrations of PG and 
the severity of dysmenorrhea have been reported (2, 4). 
 
It is accepted that the increase in PG induce hyper contractility of the uterus, which in 
consequence produce a blood flow fall and transitory ischemia during each contraction 
(2, 4, 28). At the end of menstrual cycle, endometrial tissue is torn and PG are therefore 
secreted (2). Right before ovulating phase, there is an increase in phospholipids with 
Omega-6-like chains (e.g. arachidonic acid), and occurs at the time when progesterone 
decreases (4, 28). Progesterone decrease seems to stabilize lizosomes that are rich in PG 
in the uterus (2, 28). 
 
Some physiologic differences have been described between women suffering from 
dysmenorrhea, and those that not. Women suffering from primary dysmenorrhea usually 
have higher uterine tone at steady and active states; they have a higher contractile 
frequency, and a more irregular uterine contractility. Molecular studies have reported an 
increase in the expression of pro-inflammatory genes in patients with dysmenorrhea. 
Moreover, it has been suggested that hormonal patterns also differ among these patients 
(2). 
 
Treatment  
 
As mentioned, NSAIDs, are the first line for the management of pain in dysmenorrhea, 
nevertheless, the effectiveness is reported between 64 to 100% (2, 4). Inadequate use of 
these drugs has been reported (4), and about a 15% of patients do not respond to NSAID 
treatment (2, 4). It has also been described that 54% of adolescents identifies the drugs 
that can be used for dysmenorrhea, and about 28% do not recognize a NSAID among 
three types of drugs (4). 
 
Inadequate use of NSAIDs requires stratification of cardiovascular, renal and gastric 
risks. NSAIDS should be avoided in hepatic failure, stage 3 renal disease or with any 
kidney disease. They should also be avoided in peptic disease, peptic ulcer, and 
inflammatory bowel disease (29). At the moment, no evidence exist indicating a superior 
NSAID (4, 29). Regarding oral contraceptives (OCC), meta-analysis have shown that 
long term use of OCC is associated to thromboembolic events (28, 30). Other forms of 
analgesic treatments have been described among women suffering of dysmenorrhea (1, 
2, 28). 
 

 
A recent study evaluated the characteristics of primary dysmenorrhea in college students, 
and they also evaluated their knowledge and usage of complementary forms of therapy 
(non-pharmacological). This research included 488 students from University of Manisa 
Celal Bayar of Turkey, and 87.7% reported to suffer dysmenorrhea. From those, 80.9% 
reported suffering from a moderate (4-7.9 in a VAS) to severe (8 to 10) pain. Additionally, 
they found that only 55.1% any kind of analgesic, while 72.2% used any form of non-
pharmacological therapy (1). 
 
Other authors have also reported that 98% of women have used at least one form of 
complementary therapy, however, effectiveness has been perceived of about 40% (2, 4). 
The most commonly described and used methods include local heat (known by 82.1% 
and used by 85.7%), taking a shower (87.6% and 79.2%), and massages (76.6% and 
59.6%). Music is described as known by 43.5% but used only by 31.3% (1). Several 
authors have referred that some habits such as doing exercise (1, 4), diets rich in omega-
3 (4, 28, 29), and vitamin B1, vitamin E, and drinking ginger tea have been reported to 
be effective, but more studies are still needed (28). On the other hand, doing exercise and 
local heat patches have shown the largest evidence of its analgesic effectiveness (2, 28). 
 
Neurologic changes in patients with primary dysmenorrhea 
 
It has been suggested that the repetitive exposure to painful stimuli induces a central 
sensitization (2, 31). Central sensitization is defined as an augmented response to painful 
stimuli (hyperalgesia), or to non-painful stimuli (alodinia) (2, 31, 32). It is described as 
neuronal plasticity event that occurs secondary to the exposure to painful stimuli (32). 
 
In 1944, Haman, did the firs study that described hyperalgesia in patients with 
dysmenorrhea (33). Later on, several studies have reported mixed results (2, 31), 
however, some authors included dysmenorrhea as a central sensitization syndrome (31). 
It has been suggested that the mixed results are due to methodological differences such 
as the painful stimuli used, and the menstrual cycle phase studied (2, 34). On recent 
research evaluated pain perception secondary to cervical distention, finding that higher 
perception to the painful stimuli during the follicular phase in women with primary 
dysmenorrhea compared to those without the diagnosis (35). Other study reported higher 
perception to deep muscular pain, induced through injection of saline solution, during the 
three cycle phases (menstrual, luteal and follicular) in patients with severe dysmenorrhea 
(34). 
 
Several authors have also described an association between primary dysmenorrhea and 
higher incidence of chronic pain syndromes such as irritable bowel, bladder pain 
syndrome, and fibromyalgia among others (2, 31, 36). It has been suggested that this 
higher incidence in patients with dysmenorrhea is due to mal-adaptive changes at the 
central nervous system (2, 36). In 2015, Wei et al., found differences in brain connectivity 
between the periaqueductal gray matter (PAG) with dorso- and mediolateral regions at 
prefrontal cortex of women with a 9 year history of dysmenorrhea (36).  
 
Music as a non-pharmacological analgesic 
 
It has been reported that music activates several and different central nervous system 
structures (37-49). Some these, are cortical areas that are related to pain perception such 
as primary somatosensorial cortex, insulae, and cingulate cortex (37, 39, 40). It has also 

 
been reported activation of subcortical areas that participate in descending modulation of 
pain (39, 40), including the PAG and dorsolateral prefrontal cortex (40). This supports a 
neuromodulator effect by music-induced analgesia rather than a simple distraction, 
making music a more appealing intervention for pain relief in pathologies such as 
dysmenorrhea. 
 
Between 2004 and 2015, six systematic reviews (10-15) and four meta-analyses (16-19) 
evaluating the efficacy of music listening for pain relief were identified. Three of these 
revisions described a significant effect in postoperative pain (11, 12, 14), and the meta-
analysis by Hole et al., reported a mean pain reduction of 23mm on a VAS (19). One 
meta-analysis evaluated oncologic pain (18), one evaluated rheumatologic pain, 
specifically in fibromyalgia and ostoartritis (15), and one meta-analysis evaluated pain in 
endoscopic procedures (colonoscopy, endoscopy, others); all of these reported a 
significant effect by music. Two revisions included different types of pain and also 
identified a significant effect (10, 13). Only one review did not find significant effects. 
The review by Bechtold et al. evaluated the effects of music in pain associated to 
colonoscopy, not finding any significant difference (16). 
 
It is important to note that Cepeda et al., Tsai et al., and Hole et al., identified large 
heterogeneity between their included studies due to different clinical settings, different 
populations, and different music interventions (13, 18, 19).  
 
The effect of music in analgesic requirements has also been evaluated. Some of the 
aforementioned reviews found significant reductions (13, 17, 19). Nonetheless, results by 
Bechtold et al. found no differences (16). Among the other reviews, two described varied 
results (11, 12), and four did not evaluate the analgesic requirements (10, 14, 15, 18). 
 
Regarding the use of music in gynecologic pain, Cole et al. included in their analysis 
studies in labor pain and a study on pain in cesarean section, finding significant effect in 
both (19). Since 2004, several publications on gynecological pain have been published. 
One evaluated pain in surgical abortion (41), four studied pain after cesarean section, (42-
45) and three assessed labor pain (46-48). Excluding the research on surgical abortion 
(41), and one on pain in cesarean section (46), all studies describe significant reductions 
of pain in those that listened music (42-44, 47-48). Despite that music has shown 
effectiveness in gynecologic pain, and some referring pain in dysmenorrhea to be similar 
to labor pain (3, 4); results are can´t be extended to women suffering from dysmenorrhea 
and studies directly evaluating this conditions are required. 
 
2. Objectives: 
 
2.1. General objective 
 
To evaluate the efficacy of a receptive music intervention compared to a control group 
exposed to silence, on the painful experience in primary dysmenorrhea in college students 
18 years or older from the School of Medicine and Health Sciences, Universidad del 
Rosario, Bogotá D.C., Colombia. 
 
2.2. Specific objectives 
 

 
 To describe demographic, medical history, gynecologic and obstetric history of 
the studied population. 
 To describe the analgesic strategies and drugs used for pain relief in primary 
dysmenorrhea in the studied population. 
 To evaluate the quantified perception of usual pain in primary dysmenorrhea 
using a VAS in college students 18 years or older. 
 To explore if a difference exist in the acute quantified perception of pain in 
primary dysmenorrhea, using a VAS, among 18-year or older college students 
prior to receive the music or silence interventions. 
 To evaluate if a difference exist in the acute quantified perception of pain in 
primary dysmenorrhea, using a VAS, among 18-year or older college students 
after receiving the music or silence interventions. 
 To explore if a difference exist in the change of quantified pain perception using 
a VAS in primary dysmenorrhea, from the moment prior to the intervention until 
the moment after the intervention, among 18-year or older college students that 
listened to music or stayed in silence.  
 To evaluate if a difference exist in the acute quantified perception of pain in 
primary dysmenorrhea, using a VAS, among 18-year or older college students 3 
to 6 hours after receiving the music or silence interventions  
 To explore if a difference exist in the change of quantified anxiety in primary 
dysmenorrhea, evaluated with the Zung’s scale, from the moment prior to the 
intervention until the moment after the intervention, among 18-year or older 
college student that listened to music or stayed in silence. 
 To evaluate if a difference exist in requirements of pharmacological analgesics 
for pain relief in primary dysmenorrhea, among college students that received 
music compared to those that stayed in silence after the intervention, and 3 to 6 
hours after the intervention. 
 To evaluate if differences exist in heart rate, systolic blood pressure, and diastolic 
blood pressure, using a calibrated digital sphygmomanometer, between 18-year 
or older collge students receiving music and those staying in silence. 
  
3. Material and Methods 
 
Design 
 
A prospective and single blinded randomized clinical trial will be conducted. Two groups 
will be compared, the experimental group will receive a music intervention, and control 
group will stay under the same condition and the same time with headphones in silence. 
 
Study population 
 
Female students 18 years or older matriculated to one of the programs registered at the 
School of Medicine and Health Sciences from Universidad del Rosario. Students 
volunteering to participate, those giving written consent to participate in this protocol, 
and those complying our eligibility criteria: 
 
 
 Inclusion criteria 
 
1. Students at least 18 years old. 

 
2. With legal and cognitive capacity to give written consent to participate. 
3. Patients that comply to characteristics and definition of primary dysmenorrhea 
according to literature (2, 4-8): 
a. Crampy-like pain located in the inferior abdomen, lumbar region, or 
inguinal region 
b. Pain initiating no longer than 24 hours prior to the first bleeding during 
the menstrual cycle 
c. Pain lasting 24-72 hours 
d. Pain that always occurs with menses 
4. Ability to understand and respond all questionnaires and measuring tools. 
 
 Exclusion criteria 
 
1. Prior diagnosis of endometriosis, adenomiosis, myomatous uterus, or any 
other gynecologic cause of secondary dysmenorrhea.  
2. Any degree of hearing impairment or use of auxiliary hearing devices. 
3. Diagnosed cognitive deficit or neurologic condition. 
4. Prior diagnosis of psychiatric disease, use of anxiolytic or anti-depressive 
drugs, or history of substance or alcohol abuse in the last two years. 
5. Diagnosis of cancer, diabetes mellitus, or cardiac disease. 
6. Advanced music training (receiving advanced music theory in adition to 
normal music education given by schools).  
7. Irregular menstrual cycles. 
8. Diagnosis of any endocrine disease.  
9. Current use, or use in the last two months, of oral contraceptive or other 
hormonal contraceptive method. 
10. Prior gestation or labor.  
 
Variables and measurement tools: 
 
 Demographic data: age, current studying semester, religion, and civil status will be 
collected. 
 Medical history: medical, surgical and obstetric history will be collected. 
 Menstrual cycle data: the following will be collected: 1. Menarche; 2. Time between 
each cycle; 3. Menses duration; 4. Contraceptives use. 
 Pain associated to menses: using a visual analogue scale (VAS), the usual pain 
associated to menses will be collected. The VAS useas a 10 cm line that that goes 
from 0 “I have never felt pain during my menses” to 10 “I always feel the worst of 
pain of my life during menses”. 
 Strategies used for pain relief: simple questions will be used to ask drugs and dosis 
used for pain relief, and non-pharmacological treatment use. 
 Pain intensity: a VAS will be used to measure pain intensity during menses. The 
following question will be used “How intense is your pain at this moment?” where 0 
is “I do not feel any kind of pain” and 10 is “I am feeling the worst pain of my life”. 
 Anxiety: a 10 item short version of the self-applied scale for the measurement of 
anxiety by Zung will be used (49). Zung´s scale was developed in 1971 (50), it is of 
free use, and has been studied and validated in Spanish and in colombian population 
(49, 51). De la Ossa et al., evaluated internal consistency and functional structure of 
the original scale compared to a 5 item and 10 items short versions, finding high 
consistency for all three especially for the 10-item version (49). The short version 

 
consist of items 1, 2, 3, 4, 6, 7, 8, 11 and 15 (Supplement 5). Each item has 4 possible 
answers (never, some times, most of the time, all the time), and the patient should 
only give one per item.  
 Acute analgesic requirements: the following questions will be used: 1. ¿In this 
moment would you like to take any kind of drug for pain relief? If the answer is yes, 
the generic name of the drug will be asked.  
 Analgesic requirments during the day: a collecting item that requests the following: 
1. Drug name; 2. Drug presentation; 3. Dose used; 4. Time for using the drug.  
 Vital signs: using a calibrated sphygmomanometer the following will be measured: 
systolic blood pressure, diastolic blood pressure, mean blood pressure, and heart rate. 
Blood pressure will be measured at level of the radial artery of the dominant arm. 
Measurement will be done with the patient sitting and with the arm extended at the 
level of the heart window. 
 
Procedure 
 
An open enrollment will be offered to all female students of at least 18 years old from the 
School of Medicine and Health Sciences from the university. The researchers will 
approach students that want to participate at any moment, and eligibility criteria will be 
assessed using a simple questionnaire based on inclusion and exclusion criteria. 
 
The study will be explained in detail to the students that are found to be eligible. A speech 
will be design prior to enrollment to avoid disclosing different information among 
participants. The speech will mention that: “…they will participate in a research about 
the effects of music in primary dysmenorrhea, in which they will be compared to a control 
group…”1. The speech will explain the rest of the details for the experimental part of the 
study. Finally, they will be requested to sign informed consent for participation.  
 
After signing informed consent, patients will be allocated by computer generated 
randomization. Randomized codes will be generated and information about the study will 
be put in envelops. The information inside the envelope will not disclose the allocated 
group. 
 
The intervention will be conducted after pain associated to menses begins. The 
information in the envelopes will contain instructions for the intervention. These will 
explain how to access the intervention, additionally, it will contain information on what 
to do while enrolled to the study. The patient will be instructed to avoid taking drugs or 
doing any analgesic therapy before receiving the allocated intervention. Nevertheless, it 
will be clarified to the patient that she can do any form of analgesia if needed but it should 
be informed to researchers. The intervention will be avoided if patients have to endure 
pain for 12 hours or more, or those that use any form of analgesia before the intervention. 
Both of these will be clearly instructed to participants. Patients that can’t receive the 
interventions due to the afore-mentioned situations will not be excluded as they can 
receive the intervention at any other menstrual cycle.  
 
Patients will contact the researchers for the intervention, at that moment, patient will give 
the coded number and researchers will identify a package to give (package A or package 
                                                 
1 [not in the original protocol] - Note: the final speech did not disclose the experimental group or the 
main outcome (pain) as requested by IRB for approval (communication DVN021-1-088 and approval 
communication DVN21-1-099-CEI856) - . 

 
B)1. The researcher that gives the package will not be involved in data collection nor will 
have knowledge of them. The other researcher will not know which package was given 
to the student. After receiving the package, the other researcher will guide the patient to 
the place where the intervention will be conducted. 
 
Every package will contain an MP4 electronic device and a set of headphones. Packages 
will be identical and the music device will be set to look the same visually. The researcher 
will apply a first questionnaire to collect demographic data, medical history, surgical 
history, gynecologic and obstetric history, the first VAS evaluating usual pain (VAS1) in 
dysmenorrhea, and the first measurement of vital signs (all measurements will be 
collected according the explained protocol in the variables and measurement tool section). 
After this, another VAS evaluating acute pain (VAS2) and the short version of the Zung’s 
anxiety scale will be collected. 
 
The student will put on the headphones and the researcher will set the volume at 50 dB, 
and will play the file “AUDIO 1”, and then he will leave the place. The volume is under 
security ranges stablished by Resolution 8321 of 1983 from the Ministry of Health from 
Colombia. This stablished that, the maximum level of sound intensity would be 105 dB 
for continuous expositions during 1 hour. The student should stay for 30 minutes listening 
to the AUDIO 1 file following the instructions of the package. The instructions will also 
explain to the patient that she can’t mention what she listened through the headphones 
(during the intervention or even after it). Additionally, patient will be explained that she 
can’t modify the volume during the 30 minutes. The patient is free to stop the device and 
the intervention but this should be informed to the investigator immediately. After the 30 
minutes of the intervention the researcher will enter again the room. 
 
After ending the intervention and entering back, the researcher will collect the following 
data: pain perception according to VAS (VAS3), anxiety using the Zung’s scale, vital 
signs, and the patient will be asked if she desires to take any analgesia at that moment. 
Additionally, the patient will be given another questionnaire that includes: pain 
perception using a VAS (VAS4), anxiety using the short version of the Zung’s scale, 
information about any drug or other form of analgesia used. This questionnaire should be 
answered by the student 3-6 hours after the intervention. This questionnaire should be 
delivered to the investigators. The patients will be able to bring with them any type of 
analgesic (the ones they usually used) and to initiate their usual analgesia after collection 
of variables post-intervention.  
According to the objectives of this research, the intervention will be conducted in the first 
12 hours of pain in dysmenorrhea. The first participants will be able to receive again the 
intervention, nevertheless, any additional data after the first intervention will not be 
considered for the main analysis of the study. Prior to initiating the protocol, the medical 
service from the Quinta de Mutis will be contacted and informed to assure adequate 
service for primary dysmenorrhea management for patients that request it or for those that 
need it during the intervention or after ending it.  
                                                 
1 [not in the original protocol] - Note: testing of the MP4 devices showed a sound artifact while playing 
any type of audio file. In consequence, the intervention was conducted using the same laptop for both 
groups, and blinding was done by external researchers of the School not related to this trial. This 
assured that investigators (JSMS and AMRS) where completely blinded of allocation as explained in 
the manuscript and in the final version of the protocol registered at ClinicalTrials.gov under the 
identification number NCT03593850 (all changes were approved by the IRB in the communication 
letter DVN21-1-099-CEI856) - . 

 
 
Music intervention 
 
Both groups will receive their intervention in the same physical space that will be 
assigned by the School of Medicine and Health Sciences from Universidad del Rosario. 
The place will assure a calm environment without noise or interruptions by any situation 
external to the research. Both will receive the intervention in the same conditions. 
 
Each group will receive the following intervention: 
 Control group: an audio file named AUDIO 1 will be uploaded to the MP4 device. 
The file will be a 30 minute silence file. Students in the control group will be 
siting for 30 minutes with the headphones on and in silence. 
 Experimental group: an audio file named AUDIO 1 will be uploaded to the MP4 
device. The file will be a 29 minutes and 32 seconds in duration song. The song 
will be composed by the researcher Juan Sebastian Martin-Saavedra with the 
following characteristics: 1. Tempo 60-80 bpm; 2. The song will be composed on 
a C (Do) major scale and a 4/4 key signature for the entire musical piece, 
variations during the song will be made in the relative minor scale, A (La) minor; 
3. The son will contain string and wind instruments, no percussion instruments, 
singing, lyrics, or vocalizations will be used for the song, additionally, 
synthesizers will be used. The music song will be organized in the following way: 
o Introduction 
 It will start with 45 second of complete silence. This way while the 
researcher leaves the intervention room, he won’t be able to 
identify the allocated group. 
 Then, a synthesizer will play a C (Do) note in crescendo for 6 
minutes and 11 seconds. At the same time melodic progressions 
with violin, cello, and clarinet will play. 
o Part I 
 First, the guitar (main instrument) will be introduced while playing 
arpeggios in a four chord sequence in C major. This segment will 
last about 2 minutes and 41 seconds. 
 After that, the guitar will play three different chord sequences: the 
first will be an 8 chord sequence in C major, followed by a 4 chord 
sequence in A minor, and will end with a 4 sequence in C major.   
o Part II 
 A 4 chord sequence in C major will start and then change to another 
4 chord sequence in A minor (longest segment), and will finish in 
a 4 chord sequence in C major. 
 From the minute 28 and 25 seconds the final sequence will play 
again an arpeggio until ending in a decrescendo. 
o During parts I and II, the guitar will be accompanied all the time by the C 
note in the synthesizer, a bass melody, and in sporadic passages, melodies 
in violin, cello and clarinet. Every harmonic sequence in the guitar will be 
played in different styles used in rock, ballad, and bossa-nova. 
 
It was decided to use a completely new song with the aim to identify if an exclusive 
analgesic effect by music exists. It has been suggested that music chosen by the patient 
has a larger anxiolytic and analgesic effect, however, two systematic review did not found 
significant differences in their statistical analysis (13, 19). Therefore, this methodology 

 
was decided to further investigate if the election of music influences its effect in pain 
relief. 
 
Data collection: 
 
The following figure shows the different moments for data collection: 
 
 
 
DD, demographic data; MH, medical-surgical history; GH, gyneco-obstetric history; 
VAS1, usual menses pain; VS, vital signs; VAS2, pain perception before the intervention; 
ZS1 anxiety before the intervention; VAS3, pain perception after the intervention; ZS2, 
anxiety after the intervention; AR1, analgesic requirements after the intervention; VAS4, 
pain perception 6 hours after the intervention; ZS3, anxiety 6 hours after the intervention; 
AR2, used drugs or other analgesic therapies up to 6 hours after the intervention. 
 
Sample calculation: 
 
Considering the objectives of this study, the main endpoint is the change in pain 
perception evaluated with a VAS. For the sample calculation a one sided alternative 
hypothesis, a significance level (p value) α of 0.01 and a power (1-β) of 0.90 (β=0.1) was 
stablished. 
 
The following are the null hypothesis (H0) and alternative hypothesis (H1): 
 H0: no differences in the change of the acute pain perception (ΔP) in primary 
dysmenorrhea, from before the intervention (VAS2) until the moment after the 
intervention (VAS3), among the control (CG) and the experimental (MG) groups. 
VAS2CG-VAS3CG =  VAS2MG-VAS3MG 
ΔP CG = ΔPMG 
 H1: Students listening to music (MG) will have a larger pain reduction (ΔP), from 
the moment before the intevention (VAS2) to the momento after (VAS3) the 
intervention, compared to silence group (CG). 

 
 
VAS2CG-VAS3CG <  VAS2MG-VAS3MG 
 
ΔPCG < ΔPMG 
 
The prevalence of primary dysmenorrhea in the students from two programs (medicine 
and psychology) of the School of Medicine and Health Sciences from Universida del 
Rosario was described as 73%, with a mean pain intensity of 5.8 (SD 2.0) using a VAS 
(27). Nevertheless, no studies reporting the efficacy of music listening for pain relief in 
dysmenorrhea has been published, therefore there are no data regarding the change of 
pain intensity in the studied group. Moreover, the control group will wear headphones in 
silence while resting in the same conditions, this type of control (placebo) has not been 
described in the literature and won’t allow an accurate sample calculation. Due to this, 
the first part of the study will be done as a pilot study for a better sample calculation. 
 
Nonetheless, it was decided to review data in similar context to do an initial sample 
calculation before the pilot. As mentioned, menses pain has been compared to labor pain, 
therefore, three studies evaluating this pain were review (46-48). One research compared 
music against massage and a VAS of 6 points was used so it was not considered (46). 
One study compared music against control (usual care) (47), and the other compared 
against Hoku point massage and a control group (usual care) (48). Both studies were done 
in primiparous women, and pain was measured with a 0-10 point and no additional 
analgesia was received until the intervention (47-48). These studies reported a mean age 
of 26.63 (SD 4.02) years old (47); and 21.43 (SD 2.58) years old (48). If averaged, the 
age of the studies is 24.03 years old, similar to the mean age of our target population 19.3 
(SD 2.8) (27).  
 
The mean pain before the intervention, measured at 4 cm of cervical dilation, was 6.43 
(SD 2.57) (47), and 5.58 (SD 1.29) (48). If both means are averaged, a mean perception 
is 6.01, which is similar to that of the target population (27). Mean score after the music 
intervention during the latent phase was 4.43 (SD 1.03) with a mean difference of -1.15 
that corresponds to a 20% pain reduction. For the control group the mean before the 
intervention was 6.13 and after was 6.48 that corresponds with a mean difference of + 
0.35 (increased). Comparing both differences, the change between groups was 1.58 
supporting the music group (48). The other study (47) did not report mean pain scores 
after the intervention, but they did report a mean difference between groups of 1.68 
supporting music group. Considering these reports, a mean difference between groups of 
1.5 in pain relief supporting music group was established. 
 
The following formula was used: 
n= ((AR+1)/1) · (Z[1-α]+Z[1-β])2 · σ2/Δ2 
n= sample per group 
AR (allocation rate) = 1 
Z[1-α]= 2.33 
Z[1-β]= 1.28 
σ= 2 
Δ= 1.5 
 

 
According to this, n=46.34. In consequence, 47 students per group was calculated. After 
the pilot testing a new calculation will be done with more data obtained from the studied 
population and the interventions to study1. 
 
Data analyses 
 
The SPSS for Mac, version 20, software was used for data analyses. For qualitative 
variables, frequency and percentages measurements will be used. For quantitative 
variables, central tendency measurements, variability and variance coefficients was used. 
 
The primary endpoint for the study will be the effect of music in pain in dysmenorrhea. 
The secondary endpoints will be the impact in analgesic requirements, vital signs, and 
anxiety quantification. Comparative analysis will be performed to evaluate if a 
relationship between the level of pain and analgesic requirements, anxiety levels, and 
vital signs exist. Finally, multivariate analysis (MANCOVA) will be conducted to further 
test statistical significance for the pain relieving effect of music (p < 0.01).  
 
4. Ethical considerations 
 
This study is classified as minimum risk in accordance to the stablished regulations by 
the Resolution 008430 of 1993 from the Ministry of Health of Colombia (Scientific, 
technical, and administrative norms for the research in health). 
 
All participants from the study will enroll and participate on their own desire and no 
perosn will be obligated to enroll, continue or complete the study participation. The study 
will not expose participants to drug interventions, surgical procedures or diagnostic 
procedures, physical therapy or other type of intervention that will add potential risks to 
physical integrity of participants. The study will be conducted in the Quinta de Mutis of 
the Universidad del Rosario, Bogota city. Therefore, no exposure to ambient risks will be 
related to this research. The sole intervention patients will receive is music through 
headphones. For conducting this research all recommendations from Helsinki declaration 
by the World Medical Associations will be considered.  
 
5. Activity chronogram 
 
 
ACTIVITY 
MES 
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 
PROTOCOL DEVELOPEMENT 
                                  
SEARCH FOR ADDITIONAL 
FUNDING IF REQUIRED AND IRB 
SUBMISSION 
                                  
DATA COLLECTION  
                                  
DATA ANALYSES 
                                  
PATIENT RECRUITMENT 
ACCORDING TO ELIGIBILITY 
CRITERIA 
                                  
                                                 
1 [not in the original protocol] – Note: before doing the first intervention it was deemed more 
appropriate to perform an interim analysis than a pilot study -. 

 
INTERVENTION AND DATA 
COLLECTION FROM INCLUDED 
PATIENTS 
                                  
DATA ANALYSES 
                                  
DISCUSSION OF DATA ANLYSES                                   
COMPLETE RESULTS REPORT  
                                  
MANUSCRIPT PREPARATION 
                                  
SUBMISSION FOR PUBLICATION                                   
MANDATORY SOCIAL SERVICE 
DURATION  
                                  
 
6. Expected results 
 
For our main objective, we expect to find a significant relief of pain perception in students 
with dysmenorrhea that listened to music. These results are expected to provide clin8ical 
evidence for a possible complementary therapy in the management of pain in 
dysmenorrhea, allowing to improve management of this condition and reduce analgesic 
drug requirements. Additionally, we expect to describe the prevalence, characteristics of 
pain and treatment strategies for dysmenorrhea used by the studied population. 
 
The main benefits will be for the women of reproductive age, which are affected by the 
studied condition. Furthermore, healthcare providers and medicine will benefit. 
Identifying new forms of evidence based non-pharmacological therapies will allow 
physicians or other healthcare providers to treat pain, or similar conditions to 
dysmenorrhea, in a holistic way, avoiding pharmacological therapy abuse and to reduce 
pharmacological adverse events. 
 
 
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PROJECTED BUDGET 

 
Exclusive expenses that may be required for the research: 
 Monthly salary for the physician in Mandatory Social Service as a research 
assistant for a 12 month period. The salary will be determined by the School of 
Medicine and Health Sciences.  
 Four MP4 devices and four headphone set compatible to the devices.  
 Calibrated digital sphygmomanometer. The School of Medicine and Health 
Sciences will be consulted to evaluate the availability of these instruments to be 
used for the study1.  
Total expenses associated to the research: 
 Monthly cost: 2’467,000 COP. 
 One-time costs: 240,000 COP (4 MP4 devices) + 170,000 (one new digital 
shpyngomanometer).  
The following table provides the complete projected budget: 
 
 
 
                                                 
1 [not in the original protocol] - Note: all tools (MP4 devices, laptop, and sphygmomanometer) were 
available at the School so no funding was required for the conduction of the trial  - 

 
SUPPLEMENTS 
SUPPLEMENT 1. FAST QUESTIONNAIRE: Eligibility criteria 
Answer Yes or No 
QUESTION 
YES 
NO 
Are you 18 years or older? 
 
 
Do you suffer from crampy-like pain located in the lower abdomen 
associated to menses? 
 
 
Have you ever been diagnosed with any of the following: 
endometriosis, adenomyosis, myomatous uterus? 
 
 
Have you ever been diagnosed with hearing impairment or require the 
use of hearing devices)? 
 
 
Have you ever been diagnosed with Cancer, Diabetes, Cardiac disease, 
neurologic disease, or endocrine disease? 
 
 
Do you currently use or have used in the last two months oral 
contraceptives or other hormonal contraceptive method? 
 
 
Have you ever been diagnosed with any psychiatric condition or have 
you ever required psychiatric drug use? 
 
 
Have you ever received additional music education besides that 
provided in your school? 
 
 
Have you ever been pregnant? 
 
 
 
 
 
 
 
 
 
 
 
 

 
SUPPLEMENT 2. QUESTIONNAIRE: Demographic and personal data 
Personal data 
 Age: 
 Studying program: 
 Ongoing semester: 
 Marital status : 
 Have you ever received additional music education besides that provided in your 
school? (Select one) SI     NO 
o If your answer was YES, please specify: 
________________________________________________________ 
Medical History 
Have you been diagnosed with any disease?           YES     NO 
Specify: _____________________________________________ 
Have you required surgery?  YES     NO 
Specify:______________________________________________ 
Is there any important disease in close family member (father, brother, grandparents, 
uncles/aunts)? YES     NO 
Specify:______________________________________________________________ 
Have you suffered an accident? YES       NO 
Specify:______________________________________________________________ 
Gynecologic history 
Please complete the following: 
 Pregnancy:___      Losses (Abortions):___         Born children:___  
 Age at menarche:  
 How many days do you have your menses? ______ 
 How many days do your menses last? ______ 
Regarding the pain associated to your menses: 
1. Which of the following describes better your pain? (Select one) 
a. Opressive (squeeze-like) 
b. Crampy (spasm) 
c. Burning (ardor) 
d. Other:____________________________ 
2. At what time do you start feeling pain? (Select one) 
a. 48-24 before my menses 

 
b. < 24 hours before my menses 
c. The same day of my menses 
d. First 24 hours after my menses 
e. Other:_______________________________ 
3. How much time do you feel pain during your menses? (Select one) 
a. < 10 hours 
b. 10-24 hours  
c. 24-48 hours (1-2 days) 
d. 48-72 hours (2-3 days) 
e. Other:_______________________ 
4. Which was the first time you felt pain with your menses? (Select one) 
a. With my first menarch 
b. 1-6 months after my menarche 
c. 6-12 months after my menarche 
d. 1-2 years after my menarche 
e. Other:________________________ 
5. Did you take any drug for pain relief during your last menses? YES    NO 
Drug name:_____________________________ 
Used doses (Number of tablets):_______________________________ 
E.g. Ibuprophen 4 tablets of 800 mg 
6. Did you use any form of non-pharmacological strategy for pain relief during 
your last menses? YES    NO 
Specify:__________________________________________________ 
For this part please read carefully instructions 
Visual analoge scale (VAS) consist of a 10 cm line. The line is marked with a 0 in 
one side and 10 in the other, and consider 0 as the least possible intensity and 10 as 
the greatest. For using the tool you have to put a mark that represents the perceived 
intensity that better answers the question. 
7. Consider 0 (I have never felt pain during menses) and 10 (I always feel my 
worst kind of pain). Which is your usual pain associated to menses? 
 
 
 
 
 
 
 
0 
10 

 
SUPPLEMENT 4. Questionnaire for the day of the intervention 
STUDIED VARIABLES 
The following document will be of exclusive use for the researchers during the day that 
the study is conducted. TIME:______ 
Please answer the following questions. 
1. With a single mark plese answer. How much pain are you feeling right now? 
Consider 0 as “I’m not feeling any pain” y 10 “I’m feeling the worst pain of my 
life” (patient must answer by herself). 
 
 
2. Please answer the following questions with: Never, Sometimes, Most of the time 
o Always. 
Question 
Never 
Someti
mes 
Most of 
the time 
Always 
Have you felt nervous or anxious lately 
 
 
 
 
Have you felt fearful lately 
 
 
 
 
Have you been irritated or have you panicked 
easily 
 
 
 
 
Have you felt down 
 
 
 
 
Have you felt tremulous 
 
 
 
 
Have you felt headache, pain on your back, 
or pain on your neck 
 
 
 
 
Have you felt weak and fatigue easily 
 
 
 
 
Have you felt palpitations or elevated heart 
rate 
 
 
 
 
Have you felt dizzy lately 
 
 
 
 
Have 
you 
felt 
nausea 
or 
stomack 
disturbances lately 
 
 
 
 
 
3. Answer Yes or No. Would you take an analgesic drug or other would you do 
another analgesic strategy at this moment?  If Yes, please specify: 
________________________________________________________ 
4. At this moment how much time have you felt pain? 
 
 
5. HR___ BP___ MBP____ 
 
 
0 
10 

 
Please complete the following after the intervention. 
1. With a single mark plese answer. How much pain are you feeling right now? 
Consider 0 as “I’m not feeling any pain” y 10 “I’m feeling the worst pain of my 
life” (patient must answer by herself) 
 
2. Please answer the following questions with: Never, Sometimes, Most of the time 
o Always. 
Question 
Never 
Someti
mes 
Most of 
the time 
Always 
Have you felt nervous or anxious lately 
 
 
 
 
Have you felt fearful lately 
 
 
 
 
Have you been irritated or have you panicked 
easily 
 
 
 
 
Have you felt down 
 
 
 
 
Have you felt tremulous 
 
 
 
 
Have you felt headache, pain on your back, 
or pain on your neck 
 
 
 
 
Have you felt weak and fatigue easily 
 
 
 
 
Have you felt palpitations or elevated heart 
rate 
 
 
 
 
Have you felt dizzy lately 
 
 
 
 
Have 
you 
felt 
nausea 
or 
stomack 
disturbances lately 
 
 
 
 
 
3. Answer Yes or No. Would you take an analgesic drug or other would you do 
another analgesic strategy at this moment?  If Yes, please specify:: 
________________________________________________________ 
4. HR___ BP___ MBP____ 
 
 
 
 
 
 
 
 
 
0 
10 

 
SUPPLEMENT 5. Data collection by the patient during the rest of the day 
PAIN INTENSITY DURING THE DAY 
This questionnaire is designed to be used by you (participant) 3 to 6 hours after having 
received the intervention. TIME:_____ 
Complete the following tables: 
1. If you have taken any kind of analgesic drug please fill this table with the 
following information: 
DRUG NAME 
TIME 
QUANTITY 
 
 
 
 
 
 
 
 
 
 
 
 
 
2. If you have performed any form of non-pharmacological strategy for pain please 
fill this table with the following information: 
USED STRATEGY 
TIME  
DURATION 
 
 
 
 
 
 
 
 
 
 
 
 
 
Please answer after 3-6 hours have passed from receiving the intervention. 
1. With a single mark plese answer. How much pain are you feeling right now? 
Consider 0 as “I’m not feeling any pain” y 10 “I’m feeling the worst pain of my 
life”. Please mark your answer on the line. 
 
 
 
2. Please answer the following questions with: Never, Sometimes, Most of the time 
o Always. 
0 
10 

 
Question 
Never 
Someti
mes 
Most of 
the time 
Always 
Have you felt nervous or anxious lately 
 
 
 
 
Have you felt fearful lately 
 
 
 
 
Have you been irritated or have you panicked 
easily 
 
 
 
 
Have you felt down 
 
 
 
 
Have you felt tremulous 
 
 
 
 
Have you felt headache, pain on your back, 
or pain on your neck 
 
 
 
 
Have you felt weak and fatigue easily 
 
 
 
 
Have you felt palpitations or elevated heart 
rate 
 
 
 
 
Have you felt dizzy lately 
 
 
 
 
Have 
you 
felt 
nausea 
or 
stomack 
disturbances lately 
 
 
 
 
 
 
 

 
SUPPLEMENT 6. Instructions to receive the intervention 
INSTRUCTIONS FOR RECEIVE THE INTERVENTION 
Thank you for participating in our study, please read carefully. 
WHEN WILL I RECEIVE THE INTERVENTION? 
When you start feeling pain associated to your menses the intervention will be able to 
be conducted. At this moment you should contact the researcher1.  
IMPORTANT: If it is not posible to receive the intervention during the first 12 hours 
of pain, the intervention will be avoided and it is recommended give your usual 
treatment to pain. If this happens, remember that you are not excluded from the study 
you would be able to receive the intervention in the next month. 
AT WHAT PLACE WILL THE INTERVENTION TAKE PLACE?  
The intervention will be conducted at the facilities of the Quinta de Mutis in an 
assigned place for it. The specific place will be specified when you contact the  
At what time will the intervention take place? 
The intervention will take place from Mondays to Fridays 7:00 am – 5:00 pm, 
nevertheless, you can contact the researcher to schedule the intervention outside of this 
time if needed. 
Please consider the following 
 No drug or other strategy should be used for pain relief until the intervention has 
been completed. Nonetheless, it is informed that you are in full freedom to do it 
if needed but it should be informed to the researcher. Please consider that the 
intervention will not be conducted if you use any drug or other form of 
analgesic strategy for pain relief PRIOR to receving the intervention. If this 
happens, you won’t be excluded from the study and would be able to receive the 
intervention for the next menses. 
 When you receiving the intervention, or after having received it, you can’t 
disclose to the researcher what you listened through your headphones. 
 If desired, you can stop the intervention before completing the 30 minutes but 
you have to inform the researcher who will enter and perform corresponding 
measurements. 
 If you want to receive the interention again, you can request it but the new data of 
new interventions will not be considered for the analysis. 
 Independent of the allocated group, you can request to researchers the music 
file used for this study. 
                                                 
1 Contact information: juans.martin@urosario.edu.co/ cel: 3002230897/ PBX: 2970200 ext 3426