CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 649 enrolled
Drug / intervention
Music group +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT03593850
NCT03593850N/ACompleted

Music for the Management of Pain in Primary Dysmenorrhea in Students of the School of Medicine and Health Sciences From the Universidad Del Rosario

Universidad del Rosario·interventional·Posted Jul 20, 2018·Updated May 28, 2024

In Brief

A clinical study evaluating Music group and Silence Group for Pain, Menstrual and Primary Dysmenorrhea. Completed, enrolled 649 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesColombia
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 20, 2018
Enrollment StartSep 1, 2017
Primary CompletionApr 6, 2018
Study CompletionApr 17, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.0 years ago

Interventions

Music groupbehavioral

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).

Silence Groupbehavioral

Audio file that contained no sounds.