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N/A N=52 Randomized Triple-blind Treatment

Music for Pain in Primary Dysmenorrhea

Pain, Menstrual · Primary Dysmenorrhea

Enrolled (actual)
52
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention — -1.85; -0.18 cm — p=0.002

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Music group (Behavioral); Silence Group (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
Female
Sponsor
Universidad del Rosario
Primary completion
Apr 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention
-1.85; -0.18 0.002 sig
SECONDARY
Usual Pain Associated to Menses
6.34; 6.76 0.392
SECONDARY
Actual Pain 1-5 Minutes Before the Intervention (Baseline).
4.82; 4.97 0.802
SECONDARY
Actual Pain 1-5 Minutes After the Intervention.
2.97; 4.77 0.01 sig
SECONDARY
Actual Pain 3-6 Hours After the Intervention.
2.37; 3.63 0.11
SECONDARY
Anxiety Score Before the Intervention
1.8; 1.9 0.377
SECONDARY
Anxiety Score After the Intervention
1.53; 1.73 0.049 sig
SECONDARY
Anxiety Score 3-6 Hours After the Intervention
1.49; 1.62 0.168
SECONDARY
Analgesic Requirements Before
12; 11; 17; 12 0.642
SECONDARY
Analgesic Requirements After
4; 10; 25; 13 0.02 sig
SECONDARY
Analgesic Use During a Period of 3-6 Hours After the Intervention.
6; 11; 21; 8 0.025 sig
SECONDARY
Systolic Blood Pressure Before the Intervention
108.97; 105.59 0.307
SECONDARY
Diastolic Blood Pressure Before the Intervention
71.1; 68.14 0.318
SECONDARY
Heart Rate Before the Intervention
75.48; 75.68 0.954
SECONDARY
Mean Blood Pressure Before the Intervention
83.83; 80.62 0.258
SECONDARY
Systolic Blood Pressure After the Intervention
109.66; 103.26 0.058
SECONDARY
Diastolic Blood Pressure After the Intervention
69.9; 65.26 0.056
SECONDARY
Heart Rate After the Intervention
74.48; 74.96 0.885
SECONDARY
Mean Blood Pressure After the Intervention
83.04; 77.92 0.036 sig

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.

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03593850). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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