Primary Dysmenorrhea Clinical Trial
Official title:
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
Primary dysmenorrhea is defined as lower abdominal pain that occurs during menses and is not
secondary to any type of pelvic disease. It is considered the most common condition in
reproductive age women. First line of treatment are non-steroidal anti-inflammatory drugs
(NSAIDS), or oral contraceptives (OCC). This two forms of treatment have not demonstrated
100% efficacy, and adverse events and contraindications for both exist. Moreover, studies
have demonstrated that an important women do not use, or don't like to use, pharmacological
treatment. Music have demonstrated analgesic effects in different clinical contexts, and has
emerged as an important form of complementary therapy in the management of pain. To the
researcher's knowledge, no studies have been conducted to evaluate music's effectiveness in
pain secondary to primary dysmenorrhea.
The following is the protocol for a randomized, single blinded, clinical trial, where an
experimental group listened to a 30 minute song, and was compared to a control group that
rest in silence for the same time and conditions. It was expected that music will produce a
larger, and significant, effect on pain reduction when compared to the control silence group
according to pain measured through a 10 cm Visual Analogue Scale (VAS) in young women from
the School of Medicine and Health Sciences at the Universidad del Rosario, Bogota DC,
Colombia. Additionally, the investigators wanted to evaluate the clinical effect of music and
analgesic requirements, anxiety and vital signs were also measured.
Primary Dysmenorrhea (PD) is defined as pain in the lower abdomen, that occurs always during
menses, in the absence of pelvic pathology, and lasts about 24-72 hours. It initiates during
the first 24 months after menarche. Other symptoms like, emotional lability, anxiety, nausea,
headache, and others may accompany the pain. It is considered the most common condition of
reproductive age women, and is considered one of the most important causes for school or work
absence in this population.
Music has been proposed as a complementary therapy for the management of pain, and a large
body of clinical evidence supports its use on clinical context. Additionally, functional
imaging research has found that music activates areas related to pain modulation and
perception like the periaqueductal gray matter. Moreover music seems to modify brain activity
during pain perception. Music has been shown to be effective in relieving pain secondary to
surgery, in cancer related pain, and other types of pain, but it has not been studied for
primary dysmenorrhea.
This randomized clinical trial was designed with the following objectives
General Objective: To evaluate the efficacy of music listening, compared to a control group
that rested in silence, in the painful experience secondary to primary dysmenorrhea in women
of 18 years or older from the School of Medicine and Health Sciences at the Universidad del
Rosario, Bogotá DC., Colombia.
Specific Objectives:
1. Description of demographic data, clinical, gynecological, and obstetric background from
the study population.
2. Description of pain management, secondary to PD, used by the study population.
3. Evaluate the usual pain secondary to PD, as reported by the study participants through a
Visual Analogue Scale (VAS)
4. To explore if the acute perception of pain secondary to PD, as reported by participants
using a VAS, before the intervention, is different between the study groups.
5. To evaluate if the acute perception of pain secondary to PD, as reported by participants
using a VAS, after the intervention, differs between those that listened to music and
those that rested in silence.
6. To explore if a difference in the reduction of pain, as reported by participants using a
VAS, from the moment before to the moment after the intervention exists between those in
the music group compared to those in the silence group.
7. To evaluate if the acute perception of pain secondary to PD, as reported by participants
using a VAS, 3-6 hours after the intervention, differs between those that listened to
music and those that rested in silence.
8. To evaluate if the anxiety secondary to PD, as reported by participants using a
validated Spanish short version of the Zung scale, differs between groups, before and
after the intervention.
9. To evaluate if a difference in the reported requirements of analgesic drugs is different
between the study groups after and 3-6 hours after the intervention.
10. To evaluate if a difference in heart rate, systolic and diastolic blood pressure is
identified between groups, using a previously calibrated digital sphyngmomanometer.
The investigators hypothesized that listening to an instrumental song, unknown to the
patient, will have a significant effect on pain relief. Additionally, investigators
hypothesized that music listening will have a clinical effect big enough to also impact
analgesic requirements and anxiety scores .
Primary endpoint was pain reduction from the moment before to after the intervention. Pain
reduction is the better way to evaluate analgesia efficacy and was the proper approach for
these protocol's main objective, which was efficacy of music on pain relief secondary to
primary dysmenorrhea.
For achieving these aims and answering research questions, a randomized clinical trial was
designed. As patients can't be blinded from listening or not to music, a single blinded
approach was decided. Furthermore, methodology for recruitment was designed to blind patients
from allocation until the day of the intervention and a speech was used to avoid patients to
identify the primary endpoint. Additionally, patients were explained that two interventions
were used, but it was not specified that silence group was the control group, to assure
proper blinding and avoid further bias of results. Silence was decided as a control
intervention as comparison with drug placebo may not be adequate due to differences in the
types of intervention.
To isolate the music effects the investigators decided on using a completely new and unknown
song. The song was planned and composed exclusively for the research, so all patients
allocated to the music group listened to the exact same musical piece.
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