Clinical trial NCT05971186: Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea
Official title: Single-Blinded Randomized Controlled Trial: Comparative Efficacy of Dark Chocolate, Coconut Water, and Ibuprofen in Managing Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dysmenorrhea Primary
Menstrual Pain
Ibuprofen
Keywords: Dark Chocolate
Young Coconut Water
Ibuprofen
Pain Intensity
Lead sponsor: Universitas Padjadjaran
Sponsor class: OTHER
First posted: 2023-08-02
Enrollment: 45
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: Dysmenorrhea, commonly known as period pain, is a prevalent condition that affects a large number of women during menstruation, causing discomfort and often leading to reduced productivity. While several treatments are available to alleviate the pain, there is limited information on the comparative effectiveness of different interventions, including green coconut water, dark chocolate, and Ibuprofen.

This research aimed to conduct a randomized controlled trial to compare the effectiveness of green coconut water, dark chocolate bars, and Ibuprofen in managing primary dysmenorrhea. A total of 45 participants were enrolled in the study and randomly assigned to one of three intervention groups: green coconut water, dark chocolate bars, or Ibuprofen.

The green coconut water group received 330 ml of pure green coconut water, which is known for its potential health benefits and natural electrolyte content. The dark chocolate group received 35 grams of 70% dark chocolate, as some studies have suggested its potential role in pain relief due to the presence of bioactive compounds. The Ibuprofen group received 400 mg of the common over-the-counter nonsteroidal anti-inflammatory drug (NSAID) known for its analgesic properties.

To assess the effectiveness of each intervention, pain intensity was measured before and after treatment using validated pain scales. The Kruskal-Wallis test, a non-parametric statistical method, was used to analyze the data and compare the effectiveness of the three interventions.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain Intensity
timeFrame: The Pain intensity measured 2 times. Before the intervention and two hours after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Banda Aceh
country: Indonesia
facility: Saleha Academy of Midwifery
state: Aceh
Study officials:
affiliation: Universitas Padjadjaran
name: Kaifar Nuha, STrKeb,M.Keb
role: STUDY_DIRECTOR
References: