N/A
N=52
Music for Pain in Primary Dysmenorrhea
Pain, Menstrual · Primary Dysmenorrhea
Bottom Line
View on ClinicalTrials.gov: NCT03593850 ↗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
| Outcome | Result | p-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.
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.