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

NCT06976255 | Completed DMC

• 1 other identifier: 2023-SBB-0379
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Dysmenorrhea; Pain; Anxiety

Keywords

university students; dark chocolate; cinnamon sugar

Outcome Measures

Primary Outcomes (2)

• Visual Analog Scale

  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

  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.

Study Arms (3)

Control

NO INTERVENTION

Dark chocolate

EXPERIMENTAL

Behavioral: Dark chocolate

Cinnamon sugar

EXPERIMENTAL

Behavioral: Cinnamon sugar

Interventions

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.

Cinnamon sugar

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.

Dark chocolate

Eligibility Criteria

• Age: 18 Years - 25 Years
• Gender Eligibility Details: Primary dysmenorrhea
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Trakya University: lead
• Bartın Unıversity: collaborator

Study Sites (1)

Bartın University

Bartın, Bartın, 74030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: March 30, 2024
• Primary Completion: June 30, 2024
• Study Completion: February 27, 2025
• Last Updated: May 20, 2025

Record last verified: 2025-05

Locations

TU (1)