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Completed

NCT Number: NCT05971186

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

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.

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Key information

Conditions

Dysmenorrhea Primary Dysmenorrhea Ibuprofen Menstrual Pain Menstruation Disturbances Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

17 year–24 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Saleha Academy of Midwifery

Banda Aceh, Special Region of Aceh, 23239, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: Ibuprofen 400 mg - Novapharin

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.

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.

Primary outcomes

  1. Pain Intensity

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

    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

Sponsors and collaborators

Lead sponsor

Universitas Padjadjaran

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 2, 2023
Registry last updated
Aug 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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