Single-Blinded Randomized Controlled Trial: Comparative Efficacy of Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea

703/UN6.KEP/EC/2022

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.

2022-06-30

2022-08-15

2022-08-15

Completed

Early phase I

45

Inclusion Criteria: * 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 Exclusion Criteria: * Allergies to dark chocolate or young coconut water or contraindications to Ibuprofen consumption * Diagnosed with specific gynecological conditions.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "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.\n\nSimple 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.\n\nThe 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.", 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'maskingDescription': "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.", 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 45, 'type': 'ACTUAL'}}

2023-08-02