Clinical trial NCT04911673: Effectiveness of Dark Chocolate and Music in Dysmenorrhea
Official title: The Effect of Dark Chocolate and Music on Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Primary Dysmenorrhea
Menstrual Pain
Keywords: music
dark chocolate
dysmenorrhea
pain
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 84
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Description of the students' demographics and clinical backgrounds.
timeFrame: It was implemented on the first day of the study and it took approximately 10-15 minutes to fill out the form.
measure: To evaluate pain severity secondary to dysmenorrhea in the first day of menstruation through a Visual Analogue Scale (VAS).
timeFrame: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
measure: 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).
timeFrame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
measure: 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).
timeFrame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
measure: To evaluate anxiety level in the first day of first menstruation cycle through State Anxiety Inventory (SAI).
timeFrame: The first day of the menstrual cycle 1 (each cycle is 28 days) and it is the baseline data.
measure: To evaluate the effect of dark chocolate consumption in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
timeFrame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
measure: To evaluate the effect of the music in reducing the anxiety level of students with dysmenorrhea using State-Trait Anxiety Inventory (STAI).
timeFrame: The first day of the menstrual cycle 2 (each cycle is 28 days) and it is the post intervention data.
Secondary outcomes:
Other outcomes:
Locations:
city: Manisa
country: Turkey
facility: Ebru Baysal
Study officials:
affiliation: Manisa Celal Bayar University
name: EBRU BAYSAL, PhD
role: PRINCIPAL_INVESTIGATOR
References: