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Completed

NCT Number: NCT06976255

The Effect of Dark Chocolate and Cinnamon Sugars on Pain and Anxiety in University Students With Primary Dysmenorrhea

Aim: In this prospective, randomized controlled study, the aim of this study was to investigate the effects of dark chocolate and cinnamon sugar on pain and anxiety in university students with primary dysmenorrhea. Design: The prospective, randomized controlled study

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Key information

Age range

18 year–25 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bartın University

Bartın, 74030, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • University students who had not given birth,
  • Were between the ages of 18 and 25,
  • Had regular menstrual cycles (28±7 days),
  • Had menstrual pain severity of 5 or more on the Visual Analog Scale (VAS) in the previous month,
  • Had primary dysmenorrhea, gave written informed consent,
  • Volunteered to participate in the study were included in the study.

Exclusion criteria

  • The study included patients with hearing loss, pelvic pathology, neurological, endocrine or psychiatric disease, and chronic disease such as diabetes mellitus or heart disease, currently taking medication such as antidepressants or oral contraceptives,
  • Menstrual irregularities,
  • University students who had mental problems that prevented evaluation and cooperation, obesity, malignant condition, pelvic surgery, pregnancy, analgesic use, chocolate and cinnamon allergy,
  • Use of any nutritional supplements, medication or non-drug application (reiki, meditation, reflexology, acupressure, etc.) to reduce pain,
  • University students who did not volunteer to participate in the study were excluded.

Treatment and study plan

Cinnamon sugar

Behavioral

In the 2nd and 3rd month of the study, the participants were asked to eat 1 g of cinnamon candies 3 times a day for a total of 4 days, three days before the menstrual cycle and the first day of menstruation.

Dark chocolate

Behavioral

In the 2nd and 3rd month of the study, they were asked to eat 40 mg of 60% cocoa dark chocolate daily for a total of 4 days, three days before the menstrual cycle and the first day of menstruation.

Primary outcomes

  1. Visual Analog Scale

    Time frame: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.]

    The intensity of menstrual pain will be measured using the VAS, a valid and reliable tool for measuring experimental and clinical pain. The VAS is scored on a horizontal line of 10 cm (0=no pain and 10=worst possible pain)

  2. State-Trait Anxiety Inventory

    Time frame: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.

    There are 40 items in total under two subheadings as State and Trait Anxiety. The Trait Anxiety Scale determines the individual's predisposition to experience anxiety. In the scale consisting of 20 four-point Likert-type questions, items 1, 6, 7, 10, 13, 16, 19 are reverse items. In this scale, a minimum score of 20 and a maximum score of 80 can be obtained. While a high score indicates a high level of anxiety, a low score indicates a low level of anxiety

Sponsors and collaborators

Lead sponsor

Trakya University

Other

Collaborators

  • Bartın Unıversity

Registry information

Official study title

The Effect of Dark Chocolate and Cinnamon Sugars on Pain and Anxiety in University Students With Primary Dysmenorrhea: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 20, 2025

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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