Clinical trial NCT03593850: Music for Pain in Primary Dysmenorrhea
Official title: Music for the Management of Pain in Primary Dysmenorrhea in Students of the School of Medicine and Health Sciences From the Universidad Del Rosario
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Menstrual
Primary Dysmenorrhea
Keywords: Pain management
Pain
Primary dysmenorrhea
Music
Music Therapy
Lead sponsor: Universidad del Rosario
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 649
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single blinded, two parallel group, randomized clinical trial. The experimental group received listen to a son composed exclusively for this trial while control group rested for the same amount of time in silence.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Legal and cognitive capacity for informed consent.
* Suffering from primary dysmenorrhea (low abdominal pain associated to menses).
* Being able to understand and use the measuring tools and questionnaires.

Exclusion Criteria:

* Previous diagnosis of pelvic pathology.
* Diagnosis of hearing impairment.
* Diagnosis of neurologic or endocrinological disease.
* Psychiatric condition diagnosed.
* Known or reported previous substance abuse.
* Current use of psychiatric drugs.
* Cancer diagnosis
* Diagnosed diabetes mellitus or heart disease.
* Previous advance musical training (defined as any form of music training in addition to that received during normal school classes).
* Irregular menstrual cycles.
* Previous pregnancy.
* Current use or use of any hormonal contraceptive therapy in the last 2 months.

Primary outcomes:
measure: Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention
timeFrame: From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention.
Secondary outcomes:
measure: Usual Pain Associated to Menses
timeFrame: 5-10 minutes before the intervention.
measure: Actual Pain 1-5 Minutes Before the Intervention (Baseline).
timeFrame: 1-5 minutes before the intervention.
measure: Actual Pain 1-5 Minutes After the Intervention.
timeFrame: 1-5 minutes after the intervention.
measure: Actual Pain 3-6 Hours After the Intervention.
timeFrame: 3-6 hours after the intervention.
measure: Anxiety Score Before the Intervention
timeFrame: 1-5 minutes before the intervention.
measure: Anxiety Score After the Intervention
timeFrame: 1-5 minutes after the intervention.
measure: Anxiety Score 3-6 Hours After the Intervention
timeFrame: 3-6 hours after fter the intervention.
measure: Analgesic Requirements Before
timeFrame: 1-5 minutes before the intervention the intervention.
measure: Analgesic Requirements After
timeFrame: 1-5 minutes after the intervention.
measure: Analgesic Use During a Period of 3-6 Hours After the Intervention.
timeFrame: 3-6 hours after the intervention)
measure: Systolic Blood Pressure Before the Intervention
timeFrame: 1-5 minutes before the intervention.
measure: Diastolic Blood Pressure Before the Intervention
timeFrame: 1-5 minutes before the intervention.
measure: Heart Rate Before the Intervention
timeFrame: 1-5 minutes before the intervention.
measure: Mean Blood Pressure Before the Intervention
timeFrame: 1-5 minutes before the intervention.
measure: Systolic Blood Pressure After the Intervention
timeFrame: 1-5 minutes after the intervention.
measure: Diastolic Blood Pressure After the Intervention
timeFrame: 1-5 minutes after the intervention.
measure: Heart Rate After the Intervention
timeFrame: 1-5 minutes after the intervention.
measure: Mean Blood Pressure After the Intervention
timeFrame: 1-5 minutes after the intervention.
Other outcomes:
Locations:
city: Bogotá
country: Colombia
facility: Escuela de Medicina y Ciencias de la Salud- Universidad del Rosario
state: Capital District
Study officials:
affiliation: Universidad del Rosario
name: Juan S Martin-Saavedra, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Rosario
name: Angela M Ruiz-Sternberg, MD, MSc
role: STUDY_DIRECTOR
References: