Music for Pain in Primary Dysmenorrhea

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.

Conditions

• Pain, Menstrual
• Primary Dysmenorrhea

Interventions

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).

BEHAVIORAL

Silence Group

Audio file that contained no sounds.

Sponsors & Collaborators

• Universidad del Rosario

  lead OTHER

Principal Investigators

• Juan S Martin-Saavedra, MD · Universidad del Rosario

• Angela M Ruiz-Sternberg, MD, MSc · Universidad del Rosario

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2017-09-01

Primary Completion

2018-04-06

Completion

2018-04-17

Countries

• Colombia

Study Locations