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Music for Primary Dysmenorrhea [Música Para la Dismenorrea Primaria]

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ClinicalTrials.gov Identifier: NCT03593850
Recruitment Status : Completed
First Posted : July 20, 2018
Last Update Posted : July 20, 2018
Sponsor:
Information provided by (Responsible Party):
Juan S. Martin-Saavedra, Universidad del Rosario

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.


Condition or disease Intervention/treatment Phase
Pain, Menstrual Primary Dysmenorrhea Behavioral: Music group Behavioral: Silence Group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Masking Description: Computer block randomization was used to generate allocation sequence of codes. Allocation was done on the same day of the intervention, patients were given opaque envelope according to the randomization codes. The envelop contained instructions to access the allocated intervention. After baseline data collection patients entered the intervention room and opened the envelop inside while investigator waited outside. Both patients had headphones on and used the same device to access the intervention assuring blinding of the investigator. After the intervention ended, patient closed the intervention file and account to the intervention. All patients were instructed to nor reveal or comment anything about the intervention at any time after the intervention was completed.
Primary Purpose: Treatment
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
Actual Study Start Date : July 18, 2017
Actual Primary Completion Date : April 6, 2018
Actual Study Completion Date : April 17, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Period Pain

Arm Intervention/treatment
Experimental: Music group
Patients in this arm listened through headphones to a song of 29 minutes and 32 seconds duration. The song was composed entirely by investigator Juan Martin-Saavedra and registered to copyright and authorship regulatory entities from Colombia under the name "Occasio adolore" (Musical piece No. 5-559-355 and Phonogram No. 12-105-295 of Colombia's Copyright authorship agency). Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Silence group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Behavioral: Music group
The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
Other Name: Occasio adolore

Active Comparator: Silence group
Patients on the silence group listened to a 29 minute and 32 second audio file that produced no sounds with headphones on. Patients were instructed to avoid using cellphones or other activities during the time of the intervention. Patients receive the intervention in the same room as the Music group, but for the intervention they were always alone. The room was located in a low transit place with low ambient noise.
Behavioral: Silence Group
Audio file that contained no sounds.
Other Name: Silence




Primary Outcome Measures :
  1. Change in pain from 1-5 minutes before (baseline) to 1- 5 minutes after the intervention [ Time Frame: From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention. ]
    Pain scores were measured using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain). Pain was measured 4 times, the first was usual pain associated to menses (VAS 1), actual pain 1-5 minutes before the intervention (Baseline) (VAS 2), actual pain 1-5 minutes after the intervention (VAS 3), and actual pain 3-6 hours after the intervention (VAS 4). Main outcome was pain difference between pain 1-5 minutes after, minus pain 1-5 minutes before the intervention (VAS 3-2).


Secondary Outcome Measures :
  1. Usual pain associated to menses [ Time Frame: 5-10 minutes before the intervention. ]
    Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Usual pain was evaluated before the intervention and was known as VAS 1.

  2. Actual pain 1-5 minutes before the intervention (Baseline). [ Time Frame: 1-5 minutes before the intervention. ]
    Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately before the intervention and was known as VAS 2.

  3. Actual pain 1-5 minutes after the intervention. [ Time Frame: 1-5 minutes after the intervention. ]
    Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated immediately after the intervention was completed, and was known as VAS 3.

  4. Actual pain 3-6 hours after the intervention. [ Time Frame: 3-6 hours after the intervention. ]
    Mean pain scores measured with a 10 cm visual analogue scale (VAS) where 0 was no pain at all and 10 the worst possible pain. Actual pain was evaluated 3-6 hours after the intervention was completed, and was known as VAS 4.

  5. Anxiety score before the intervention [ Time Frame: 1-5 minutes before the intervention. ]
    Using a validated short spanish version of the Zung anxiety scale, anxiety was measured before the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety.

  6. Anxiety score after the intervention [ Time Frame: 1-5 minutes after the intervention. ]
    Using a validated short spanish version of the Zung anxiety scale, anxiety was measured after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety.

  7. Anxiety score 3-6 hours after the intervention [ Time Frame: 3-6 hours after fter the intervention. ]
    Using a validated short spanish version of the Zung anxiety scale, anxiety was measured 3-6 hours after the intervention. The scale was composed of 10 items. Each item had a 4 Likert point scale (1= never, 2= some times, 3= most of the time, and 4 = always). Scores ranged from 10, minimum anxiety, and 40 maximum anxiety. For analysis, mean quantitative scores were obtained so 1 was equivalent to minimum anxiety, and 4 to maximum anxiety.

  8. Analgesic requirements before [ Time Frame: 1-5 minutes before the intervention the intervention. ]
    Before the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no.

  9. Analgesic requirements after [ Time Frame: 1-5 minutes after the intervention. ]
    After the intervention patients were asked if they wanted to use any analgesic drug or do any kind of analgesic strategy. Patients simply answered yes or no.

  10. Analgesic use during a period of 3-6 hours after the intervention. [ Time Frame: 3-6 hours after the intervention) ]
    After the intervention, all patients had to register all analgesic drugs (e.g. ibuprofen) or strategy (e.g. local heat) that were used until last pain measurement (VAS 4, 3-6 hours after the intervention).

  11. Systolic blood pressure before the intervention [ Time Frame: 1-5 minutes before the intervention. ]
    Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.

  12. Diastolic blood pressure before the intervention [ Time Frame: 1-5 minutes before the intervention. ]
    Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.

  13. Heart rate before the intervention [ Time Frame: 1-5 minutes before the intervention. ]
    Heart rate measured in beats per minute (bpm) with a calibrated digital sphygmomanometer before the intervention.

  14. Mean blood pressure before the intervention [ Time Frame: 1-5 minutes before the intervention. ]
    Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer before the intervention.

  15. Systolic blood pressure after the intervention [ Time Frame: 1-5 minutes after the intervention. ]
    Systolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.

  16. Diastolic blood pressure after the intervention [ Time Frame: 1-5 minutes after the intervention. ]
    Diastolic blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.

  17. Heart rate after the intervention [ Time Frame: 1-5 minutes after the intervention. ]
    Heart rate in beats per minute (bpm) measured with a calibrated digital sphygmomanometer after the intervention.

  18. Mean blood pressure after the intervention [ Time Frame: 1-5 minutes after the intervention. ]
    Mean blood pressure in mmHg measured with a calibrated digital sphygmomanometer after the intervention.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593850


Locations
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Colombia
Escuela de Medicina y Ciencias de la Salud- Universidad del Rosario
Bogotá, Capital District, Colombia, 111211
Sponsors and Collaborators
Universidad del Rosario
Investigators
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Principal Investigator: Juan S Martin-Saavedra, MD Universidad del Rosario
Study Director: Angela M Ruiz-Sternberg, MD, MSc Universidad del Rosario
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Responsible Party: Juan S. Martin-Saavedra, Research Assistant, Universidad del Rosario
ClinicalTrials.gov Identifier: NCT03593850    
Other Study ID Numbers: CEI856
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 20, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results fromt the research will be made available as supplemental data or digital content published with the final manuscript. Additional information like the study protocol, statistic analysis plan performed, and copy of the informed consent will be available by request to the email: juans.martin@urosario.edu.co
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Complete database will be made available with publication of the manuscript. Other information will be accessible by request to the email: juans.martin@urosario.edu.co
Access Criteria: Complete database results will be available as digital content with the final manuscript. Additional data will be given by request by email and requester will require to send a letter with signature stating the reason for requesting additional information.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Juan S. Martin-Saavedra, Universidad del Rosario:
Pain management
Pain
Primary dysmenorrhea
Music
Music Therapy
Additional relevant MeSH terms:
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Dysmenorrhea
Menstruation Disturbances
Pathologic Processes
Pelvic Pain
Pain
Neurologic Manifestations