Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea

NCT05971186 | Completed Phase 2 DMC

• 1 other identifier: 703/UN6.KEP/EC/2022
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Dysmenorrhea, the painful condition experienced by women during menstruation, affects a significant proportion of women worldwide and often leads to decreased productivity. Various pharmacological and non-pharmacological treatments are available for pain relief, but information on their effectiveness, particularly regarding green coconut water, dark chocolate, and Ibuprofen, remains limited. This study aimed to compare the effectiveness of green coconut water, dark chocolate bars, and Ibuprofen in reducing the intensity of primary dysmenorrhea. A randomized controlled trial with a quantitative design was conducted, involving 45 participants randomly assigned to receive either 330 ml of green coconut water, 35 grams of 70% dark chocolate, or 400 mg Ibuprofen. Pain intensity was measured before and after treatment.

Conditions

Dysmenorrhea Primary; Menstrual Pain; Ibuprofen

Keywords

Dark Chocolate; Young Coconut Water; Ibuprofen; Pain Intensity

Outcome Measures

Primary Outcomes (1)

• Pain Intensity

  Pain intensity was measured using a Numeric Rating Scale (NRS) observation sheet, allowing respondents to rate their pain intensity on a scale from 0 to 10

  The Pain intensity measured 2 times. Before the intervention and two hours after the intervention

Study Arms (3)

Ibuprofen

ACTIVE COMPARATOR

Fifteen participants were randomly selected to form the third intervention group. Each subject in this arm received a single tablet of Ibuprofen, with a dosage of 400 mg. Similar to the other arms, they were given a 15-minute window to take the Ibuprofen tablet. Prior to administering the Ibuprofen, the pain intensity of the participants was measured using the standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was measured again two hours after the consumption of the Ibuprofen tablet, using the same Numeric Rating Scale (NRS).

Drug: Ibuprofen 400 mg

Young Coconut Water

ACTIVE COMPARATOR

Fifteen participants were randomly selected to join the intervention group. Each subject in this arm received a single dose of 330 ml of young coconut water. To ensure uniformity, they were given a 15-minute window to consume the entire 330 ml of the young coconut water intervention. Before administering the young coconut water, the pain intensity of the participants was measured using a standardized Numeric Rating Scale (NRS). Additionally, the pain intensity was reevaluated two hours after the consumption of the young coconut water, using the same Numeric Rating Scale (NRS).

Other: Young Coconut Water

Dark Chocolate Bar

ACTIVE COMPARATOR

Fifteen participants were also randomly chosen for the second intervention group. In this arm, each subject received a single 70% dark chocolate bar weighing 35 grams. Similar to Arm 1, they were given a 15-minute timeframe to consume the entire dark chocolate bar intervention. Prior to giving the dark chocolate bar, the pain intensity of the participants was measured using the Numeric Rating Scale (NRS). Subsequently, the pain intensity was reassessed two hours after the consumption of the dark chocolate bar, using the same Numeric Rating Scale (NRS).

Other: Dark Chocolate Bar

Interventions

Ibuprofen 400 mg DRUG

Dosage Form: Tablet Dosage: 1 tablet of Ibuprofen (400 mg) Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption

Also known as: Ibuprofen 400 mg - Novapharin

Ibuprofen

Young Coconut Water OTHER

Dosage Form: Liquid (coconut water) Dosage: 330 ml (milliliters) of young coconut water Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.

Young Coconut Water

Dark Chocolate Bar OTHER

Dosage Form: Solid (dark chocolate bar) Dosage: 35 grams of 70% dark chocolate Frequency: One-time consumption Duration: Pain intensity measured before consumption and two hours after consumption.

Dark Chocolate Bar

Eligibility Criteria

• Age: 17 Years - 24 Years
• Gender Eligibility Details: In this study, eligibility criteria based on gender require the participation of individuals identifying as female. The research focuses on assessing the effectiveness of interventions for managing primary dysmenorrhea, a condition specific to individuals with female reproductive systems. Therefore, only individuals who identify as female and experience primary dysmenorrhea are eligible to participate in this study. All other gender identities are not included in the eligibility criteria, as the study aims to investigate the impact of the interventions specifically on female participants with primary dysmenorrhea.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Women aged between 17 and 24 years
• Diagnosed with primary dysmenorrhea based on specific characteristics and assessment
• Willing to refrain from using any pharmacological or non-pharmacological therapies other than the interventions provided by the researcher
• willing to participate as respondents

You may not qualify if:

• Allergies to dark chocolate or young coconut water or contraindications to Ibuprofen consumption
• Diagnosed with specific gynecological conditions.

Sponsors & Collaborators

• Universitas Padjadjaran: lead

Study Sites (1)

Saleha Academy of Midwifery

Banda Aceh, Special Region of Aceh, 23239, Indonesia

Location

Related Publications (1)

• Nuha K, Rusmil K, Ganiem AR, Permadi W, Diah Herawati DM. Single-Blind Randomized Controlled Trial: Comparative Efficacy of Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea. Int J Environ Res Public Health. 2023 Aug 21;20(16):6619. doi: 10.3390/ijerph20166619.

  PMID: 37623203 DERIVED

MeSH Terms

Conditions

Dysmenorrhea; Pain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Kaifar Nuha, STrKeb,M.Keb

  Universitas Padjadjaran

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This quantitative study uses a Single-blind Randomized Controlled Trial (RCT) design. Key roles, including researcher, subjects, data analyst, collector, and assistant, ensure blinding to individual treatments. Blinding subjects is infeasible due to distinct interventions (young coconut water, dark chocolate, Ibuprofen). The research hypothesis remains undisclosed in the Informed Consent. Subjects won't discuss interventions with involved parties. Implementing this robust design aims to generate unbiased results contributing to scientific knowledge.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The sample comprised 45 female students from Saleha Midwifery Academy who met the inclusion criteria and voluntarily consented after a detailed explanation. Sample size was determined using the Federer formula, yielding a minimum of 9 participants per group. However, 15 samples were included in each of the three treatment groups, resulting in a total of 45 subjects due to the three interventions. Simple random sampling via Microsoft Excel's random name selection feature was used to select participants from the accessible population. Random allocation to treatment or control groups was done without bias, using a blocking system and designated application. The samples were divided into three groups: Group 1 received young coconut water, Group 2 received 70% dark chocolate bar, and Group 3 received 1 tablet of Ibuprofen, an NSAID. Allocation to each group was randomized using a designated application and a block system.

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: August 2, 2023
• Study Start: June 30, 2022
• Primary Completion: August 15, 2022
• Study Completion: August 15, 2022
• Last Updated: August 2, 2023

Record last verified: 2023-08

Locations

ID (1)