Music for the Management of Pain in Primary Dysmenorrhea in Students of the School of Medicine and Health Sciences From the Universidad Del Rosario
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 649
- 试验地点
- 2
- 主要终点
- Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention
研究概览
简要总结
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.
详细描述
Primary Dysmenorrhea (PD) is defined as pain in the lower abdomen, that occurs always during menses, in the absence of pelvic pathology, and lasts about 24-72 hours. It initiates during the first 24 months after menarche. Other symptoms like, emotional lability, anxiety, nausea, headache, and others may accompany the pain. It is considered the most common condition of reproductive age women, and is considered one of the most important causes for school or work absence in this population.
Music has been proposed as a complementary therapy for the management of pain, and a large body of clinical evidence supports its use on clinical context. Additionally, functional imaging research has found that music activates areas related to pain modulation and perception like the periaqueductal gray matter. Moreover music seems to modify brain activity during pain perception. Music has been shown to be effective in relieving pain secondary to surgery, in cancer related pain, and other types of pain, but it has not been studied for primary dysmenorrhea.
This randomized clinical trial was designed with the following objectives
General Objective: To evaluate the efficacy of music listening, compared to a control group that rested in silence, in the painful experience secondary to primary dysmenorrhea in women of 18 years or older from the School of Medicine and Health Sciences at the Universidad del Rosario, Bogotá DC., Colombia.
Specific Objectives:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Change in Pain From 1-5 Minutes Before (Baseline) to 1- 5 Minutes After the Intervention
时间窗: From 1-5 minutes before the intervention (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).
次要结局
- Actual Pain 1-5 Minutes Before the Intervention (Baseline).(1-5 minutes before the intervention.)
- Usual Pain Associated to Menses(5-10 minutes before the intervention.)
- Anxiety Score Before the Intervention(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 3-6 Hours After the Intervention(3-6 hours after fter the intervention.)
- Diastolic Blood Pressure Before the Intervention(1-5 minutes before the intervention.)
- Heart Rate Before the Intervention(1-5 minutes before the intervention.)
- Anxiety Score After the Intervention(1-5 minutes after the intervention.)
- Analgesic Use During a Period of 3-6 Hours After the Intervention.(3-6 hours after the intervention))
- Analgesic Requirements Before(1-5 minutes before the intervention the intervention.)
- Analgesic Requirements After(1-5 minutes after the intervention.)
- Systolic Blood Pressure Before the Intervention(1-5 minutes before the intervention.)
- Mean Blood Pressure Before the Intervention(1-5 minutes before the intervention.)
- Systolic Blood Pressure After the Intervention(1-5 minutes after the intervention.)
- Diastolic Blood Pressure After the Intervention(1-5 minutes after the intervention.)
- Heart Rate After the Intervention(1-5 minutes after the intervention.)
- Mean Blood Pressure After the Intervention(1-5 minutes after the intervention.)
研究者
Juan S. Martin-Saavedra
Research Assistant
Universidad del Rosario