Primary DysmenorrheaNCT06976255
The Effect of Dark Chocolate and Cinnamon Sugars on Pain and Anxiety in University Students With Primary Dysmenorrhea
A study testing Cinnamon sugar and Dark chocolate in people with Primary Dysmenorrhea and Pain, run by Trakya University at 1 site in Turkey (Türkiye).
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Primary Dysmenorrhea, Pain, Anxiety
- What is being tested?
- Cinnamon sugar and Dark chocolate
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Mar 2024to 27 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Primary Dysmenorrhea, Pain, Anxiety
- Being tested
- Cinnamon sugar, Dark chocolate
- Keywords
- university students, dark chocolate, cinnamon sugar
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cinnamon sugarBehavioural
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 chocolateBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Dark chocolate | Experimental | Not described Receives: Behavioral: Dark chocolate |
| Cinnamon sugar | Experimental | Not described Receives: Behavioral: Cinnamon sugar |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start30 Mar 2024
- Primary completion30 Jun 2024
- Study completion27 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary DysmenorrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trakya University
- Sponsor type
- University, hospital or other
- Collaborators
- Bartın Unıversity
- Responsible party
- Principal investigator, Burcu KUCUKKAYA, Bartın Unıversity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06976255
- Sponsor's protocol ID
- 2023-SBB-0379
- Status last verified
- May 2025
- First submitted
- 8 May 2025
- Last updated
- 20 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Dark Chocolate and Cinnamon Sugars on Pain and Anxiety in University Students With Primary Dysmenorrhea: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06976255
- Acronym / sponsor ID
- 2023-SBB-0379
- Conditions
- Primary Dysmenorrhea, Pain, Anxiety
- Keywords
- university students, dark chocolate, cinnamon sugar
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Trakya UniversityUniversity, hospital or other
- Collaborators
- Bartın Unıversity
- Study start
- 30 Mar 2024 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 27 Feb 2025 (actual)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Dark chocolate | Experimental | Behavioral: Dark chocolate |
| Cinnamon sugar | Experimental | Behavioral: Cinnamon sugar |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cinnamon sugarIn 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. | Behavioural | Cinnamon sugar |
| Dark chocolateIn 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. | Behavioural | Dark chocolate |
Primary outcome
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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cinnamon sugar and Dark chocolate in people with Primary Dysmenorrhea and Pain, run by Trakya University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: change from before implamentation patent and after 1st, 2nd, and 3rd months of practice.]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2025.