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

May 19, 2025 updated by: Burcu KUCUKKAYA, Trakya University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bartın, Turkey, 74030
        • Bartın University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Dark chocolate
Behavioral: Dark chocolate
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.
Experimental: Cinnamon sugar
Behavioral: Cinnamon sugar
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.]
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
change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Trakya University

Collaborators

Bartın Unıversity

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 30, 2024

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

February 27, 2025

Study Registration Dates

First Submitted

May 8, 2025

First Submitted That Met QC Criteria

May 8, 2025

First Posted (Actual)

May 16, 2025

Study Record Updates

Last Update Posted (Estimated)

May 20, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-SBB-0379

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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