Effectiveness of Dark Chocolate and Music in Dysmenorrhea

NCT ID: NCT04911673

Last Updated: 2022-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-30
• Study Completion Date: 2021-12-30

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.

Conditions

Pain; Primary Dysmenorrhea; Menstrual Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Music group

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.

Group Type: EXPERIMENTAL

music

Intervention Type: BEHAVIORAL

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).

Chocolate group

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.

Group Type: EXPERIMENTAL

Chocolate group

Intervention Type: DIETARY_SUPPLEMENT

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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

music

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: BEHAVIORAL

Chocolate group

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.

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Celal Bayar University

OTHER

Sponsor Role: lead

Responsible Party

Ebru Baysal

Principal Investigator (Research Assistant)

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

EBRU BAYSAL, PhD

Role: PRINCIPAL_INVESTIGATOR

Manisa Celal Bayar University

Locations

Ebru Baysal

Manisa, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

CelalBayar

Identifier Type: -

Identifier Source: org_study_id