Effectiveness of Dark Chocolate and Music in Dysmenorrhea

Study Overview
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Brief Summary
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Primary dysmenorrhea (PD) is a pain that occurs in the menstrual period without pathological pelvic disorder. Excessive prostaglandin release causes uterine contraction and leads to uterine hypoxia and ischemia, which results in extreme abdominal cramps and pain. Music therapy is one of the complementary treatment methods in the management of pain for PD which is an intervention that is not expensive and has no side effects. Another complementary treatment method is for PD is chocolate. In the literature; there have a few studies about the effect of the music and dark chocolate on the primary dysmenorrhea but no studies have been conducted to evaluate the effects of the music and dark chocolate on PD. The following is the protocol for a randomized controlled clinical trial, where an experimental group 1 listened to a 30-minute song, an experimental group 2 ate dark chocolate and a control group had no intervention for the same time and conditions. The aim of this study is to determine the effect of dark chocolate and music on PD. This pain measured through a 10 cm Visual Analogue Scale (VAS) in nursing students from the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey. Additionally, State-Trait Anxiety Inventory (STAI) was used to assess the trait and state anxiety.

Detailed Description
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Primary Dysmenorrhea (PD) is defined as cramping pain in the lower abdomen, which occurs before or during menstruation without pelvic diseases. Contraceptive pills and non steroidal anti inflammatory drugs are commonly used in the treatment of PD. International (66.5% to 92.5%) and Turkey (87.7% to 80.1%) in the studies among university students show that a high percentage of dysmenorrhea. Dysmenorrhea negatively affects the school absenteeism of girls, their academic success and causes a lack of concentration. The rate of using pain medication due to dysmenorrhea is high among students. Music therapy has been shown to be effective in relaxing the mind and body, relieving anxiety, enhancing security, and increasing pain thresholds. Dark chocolate contains copper, which is used by the body to synthesize neurotransmitters called collagen and endorphins. Endorphin hormone is an analgesic and natural sedative to reduce pain intensity such as menstrual pain. This randomized clinical trial was designed to determine the effect of eating dark chocolate and listening music on PD, compared to a control group that no intervention in women of 18 years or older from the the Faculty of Health Sciences at the Manisa Celal Bayar University, Manisa, Turkey.

Official Title
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The Effect of Dark Chocolate and Music on Primary Dysmenorrhea

Conditions
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Pain, Primary Dysmenorrhea, Menstrual Pain

Intervention / Treatment
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* Behavioral: music
* Dietary Supplement: Chocolate group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Legal and cognitive capacity for informed consent. Suffering from primary dysmenorrhea (low abdominal pain associated to menses). (five and above in VAS) Being able to understand and use the measuring tools and questionnaires. 18-25 years old Studying in Manisa Celal Bayar University, Faculty of Health Sciences, Department of Nursing, in the 2020-2021 academic year, in the 1st, 2nd, 3rd and 4th grades, 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 chronic diseases such as 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 of any hormonal contraceptive therapy Having allergy to chocolate Being obese Taking vitamin supplements Students who do not agree to participate in the research

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Music group<br>Participants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). The song was composed by Juan Martin Saavedra. In the first month, music group was filled the State Anxiety Inventory (SAI) between 10 and 20th of the menstruation that SAI consists of 20 statements that ask people to describe how they generally feel. In the second month, pain scores were measured on the first day of menstruation using a visual analogue scale (VAS) of 10 cm (0 no pain at all, and 10 the worst possible pain) and Trait Anxiety Inventory (TAI) was filled to assess the anxiety.In the third month, after the participants were listening the music in three days before menstruation and the first day of menstruation (during four days), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. | Behavioral: music<br>* Participants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation).<br>|
| Experimental: Chocolate group<br>Participants ate 40 mg of dark chocolate with 60% cocoa per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them. In the first month, chocolate group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation.In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety.In the third month, after the participants were eating 40 mg of dark chocolate per day in three days before menstruation and the first day of menstruation (during four days/total 160 mg), pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. | Dietary Supplement: Chocolate group<br>* Participants ate 40 mg of dark chocolate with 60% cocoa per a day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them.<br>|
| No Intervention: Control group<br>Control group had no intervention. In the first month, control group was filled the SAI to assess state anxiety between 10 and 20th of the menstruation. In the second month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the trait anxiety. In the third month, pain scores were measured on the first day of menstruation using VAS and TAI was filled to assess the anxiety. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the students' demographics and clinical backgrounds. | Questions about the sociodemographic characteristics and dysmenorrhea characteristics of the students were asked using the individual identification form developed by the researchers in line with the literature. | It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form. | 
| To evaluate pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS). | We asked them to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. | The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data. | 
| To evaluate the effect of dark chocolate consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS). | We asked them to eat dark chocolate and determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Participants ate 40 mg of dark chocolate per day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them. | The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data. | 
| To evaluate the effect of music consumption in reducing the pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS). | We asked them listen to music and to determine the severest pain score they felt on the first day of menstruation according to the VAS scale. The highest pain score that can be obtained on the VAS scale is 10 and the lowest is 0. Students listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation). Participants were instructed to avoid using cellphones or other activities during the time of the intervention. | The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data. | 
| To evaluate anxiety level in the first day of first menstruation cycle through State Anxiety Inventory (SAI). | In the first day of first menstrual cycle, students was filled the State Anxiety Inventory (SAI) that SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). | The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data. | 
| To evaluate the effect of dark chocolate consumption in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI). | We asked them to eat dark chocolate and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). | The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data. | 
| To evaluate the effect of the music in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI). | We asked them to listen the music and filled the State Anxiety Inventory (SAI)in the first day of first menstrual cycle. The SAI consists of 20 statements that ask people to describe how they generally feel. Each question is rated on a 4-point scale (not at all, somewhat, moderately so, very much so). The SAI varies from a minimum score of 20 to a maximum score of 80. SAI scores are commonly classified as no or low anxiety (20-37), moderate anxiety (38-44), and high anxiety (45-80). | The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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music, dark chocolate, dysmenorrhea, pain