Back to resultsEffectiveness of Dark Chocolate and Music in Dysmenorrhea
Primary Purpose
Pain, Primary Dysmenorrhea, Menstrual Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
music
Chocolate group
Sponsored by
About this trial
This is an interventional prevention trial for Pain focused on measuring music, dark chocolate, dysmenorrhea, pain
Eligibility Criteria
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
Sites / Locations
- Ebru Baysal
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Music group
Chocolate group
Control group
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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).
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04911673
Brief Title
Effectiveness of Dark Chocolate and Music in Dysmenorrhea
Official Title
The Effect of Dark Chocolate and Music on Primary Dysmenorrhea
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 30, 2021 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
December 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Celal Bayar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Primary Dysmenorrhea, Menstrual Pain
Keywords
music, dark chocolate, dysmenorrhea, pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
The name of students were listed in alphabetical order. The researchers gave each students a number. Then, the odd numbers were determined as the experimental and the even numbers as the control group with the lottery method. Using the table of random numbers, the intervention groups were divided into intervention group 1 (music therapy) and intervention group 2 (chocolate group).
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Music group
Arm Type
Experimental
Arm Description
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.
Arm Title
Chocolate group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
music
Intervention Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Chocolate group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Description of the students' demographics and clinical backgrounds.
Description
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.
Time Frame
It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
Title
To evaluate pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
Description
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.
Time Frame
The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
Title
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).
Description
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.
Time Frame
The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
Title
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).
Description
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.
Time Frame
The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
Title
To evaluate anxiety level in the first day of first menstruation cycle through State Anxiety Inventory (SAI).
Description
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).
Time Frame
The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
Title
To evaluate the effect of dark chocolate consumption in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
Description
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).
Time Frame
The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
Title
To evaluate the effect of the music in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
Description
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).
Time Frame
The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
18-25 years old
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
EBRU BAYSAL, PhD
Organizational Affiliation
Manisa Celal Bayar University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ebru Baysal
City
Manisa
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effectiveness of Dark Chocolate and Music in Dysmenorrhea
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