Music for Pain in Primary Dysmenorrhea

NCT03593850 | Completed Results

• 1 other identifier: CEI856
• Study Type: interventional
• Target: 649
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Menstrual; Primary Dysmenorrhea

Keywords

Pain management; Pain; Primary dysmenorrhea; Music; Music Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Pain From 1-5 Minutes Before (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) at each time point. Main outcome was calculated from the difference between visual analogue score at 1-5 minutes after (VAS3) minus visual analogue score at 1-5 minutes before the intervention (VAS2).

  From 1-5 minutes before the intervention (baseline) to 1-5 minutes after the intervention.

Secondary Outcomes (18)

• Usual Pain Associated to Menses

  5-10 minutes before the intervention.

• Actual Pain 1-5 Minutes Before the Intervention (Baseline).

  1-5 minutes before the intervention.

• Actual Pain 1-5 Minutes After the Intervention.

  1-5 minutes after the intervention.

• Actual Pain 3-6 Hours After the Intervention.

  3-6 hours after the intervention.

• Anxiety Score Before the Intervention

  1-5 minutes before the intervention.

Study Arms (2)

Music group

EXPERIMENTAL

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

Silence group

ACTIVE COMPARATOR

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

Interventions

Music group BEHAVIORAL

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).

Also known as: Occasio adolore

Music group

Silence Group BEHAVIORAL

Audio file that contained no sounds.

Also known as: Silence

Silence group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad del Rosario: lead

Study Sites (1)

Escuela de Medicina y Ciencias de la Salud- Universidad del Rosario

Bogotá, Capital District, 111211, Colombia

Location

MeSH Terms

Conditions

Dysmenorrhea; Agnosia; Pain

Interventions

SIR1 protein, S cerevisiae

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Limitations and Caveats

Patient was not blinded given it is impossible to blind someone from listening to music. Early termination leading to smaller number of subjects analyzed.

Results Point of Contact

• Title: Dr. Juan Sebastian Martin Saavedra
• Organization: Universidad del Rosario

juans.martin@urosario.edu.co

2672200532

Study Officials

• Juan S Martin-Saavedra, MD

  Universidad del Rosario

  PRINCIPAL INVESTIGATOR

• Angela M Ruiz-Sternberg, MD, MSc

  Universidad del Rosario

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: June 4, 2018
• First Posted: July 20, 2018
• Study Start: September 1, 2017
• Primary Completion: April 6, 2018
• Study Completion: April 17, 2018
• Last Updated: May 28, 2024
• Results First Posted: May 28, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

CO (1)