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FibromyalgiaNCT07326163

The Effect of Peppermint Oil Aromatherapy on Pain, Functional Capacity and Cost in Fibromyalgia Patients

A study testing Peppermint Oil, sweet almond oil and Duloxetine in people with Fibromyalgia and Aromatherapy, run by Bilecik Seyh Edebali Universitesi at 1 site in Turkey (Türkiye).

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This study was designed to evaluate the effect of topically applied peppermint oil (Mentha × piperita) on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fibromyalgia, Aromatherapy, Cost
What is being tested?
Peppermint Oil, sweet almond oil and Duloxetine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
175 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Mar 2026to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with fibromyalgia according to the 2010 American College of Rheumatology diagnostic criteria,
  • Experiencing chronic pain,
  • Volunteers to participate in the study,
  • Aged 18 years or older,

Who cannot join

  • Those with painful medical conditions other than fibromyalgia (e.g., migraine, diabetic neuropathy, etc.),
  • Those with a chronic respiratory system disease (history of asthma or another reactive airway disease),
  • Individuals with compromised skin integrity in the application areas,
  • Pregnant and/or breastfeeding women,
  • Individuals with neurocognitive impairment who are unable to answer the questionnaire,
  • Individuals with a known history of allergies,
Show all 12Show fewer
  • Individuals using any topical products during the application period,
  • Individuals receiving other complementary treatments for chronic pain management.
  • Criteria for discontinuing the study:
  • Patients who continue their treatment at a different centre after being included in the study,
  • Patients who undergo any medication or treatment changes during the study period,
  • Patients who are bothered by the scent of the essential oils used (peppermint oil (Mentha × piperita) and sweet almond oil (Prunus amygdalus var. dulcis), or who develop an allergic reaction to essential oils.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site
  • Bilecik Training and Research Hospital

    Bilecik, Bilecik, 11000

Other trials in Turkey (Türkiye)

About this study

This study was designed to evaluate the effect of topically applied peppermint oil (Mentha × piperita) on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness.

Read the detailed description

Fibromyalgia is a chronic pain condition characterized by widespread musculoskeletal pain, hyperalgesia, and allodynia, often associated with other symptoms such as fatigue, poor sleep quality, anxiety, and depression. The main symptoms of fibromyalgia include widespread body pain, tender points, muscle stiffness, and joint stiffness, but it is also accompanied by insomnia, fatigue, mood disorders, cognitive dysfunction, anxiety, depression, and difficulty in maintaining daily activities. Fibromyalgia is the third most common musculoskeletal disorder in terms of prevalence after low back pain and osteoarthritis, with prevalence rates ranging from 1.3% to 8.8% depending on the country. Pain can occur at 18 different points on the head, neck, trunk, and extremities, and can increase throughout the day. The presence of chronic and widespread pain leads to fatigue, sleep disorders, depression, anxiety, helplessness, and mental stress, reducing the quality of life for patients. Additionally, these widespread complaints complicate treatment and increase healthcare costs for patients seeking medical help for fibromyalgia. It is estimated that the total healthcare costs for fibromyalgia patients are three times higher than for other individuals. Both pharmacological and non-pharmacological methods are used in the treatment of fibromyalgia, and aromatherapy is among these methods. Considering the analgesic effects and safe usage profile of peppermint oil, its effectiveness in pain management for fibromyalgia patients is being evaluated. This study aims to assess the impact of topically applied peppermint oil on chronic pain and functional capacity experienced by fibromyalgia patients, as well as its cost-effectiveness.

Being tested
Peppermint Oil, sweet almond oil, Duloxetine
Keywords
Aromatherapy, Fibromyalgia, Pain, Functional Capacity, Cost
Medical subject headings
Fibromyalgia, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Peppermint OilOther

    This group of patients will be introduced to the tender points where chronic pain is detected in fibromyalgia patients, and the areas where these tender points are located will be divided into six regions, which will be identified with the patient. Subsequently, one drop of peppermint oil will be applied transdermally to the inner surface of the patient's forearm, and the application site will be monitored for allergic reactions such as redness or swelling. Patients who do not report any allergic reactions will apply 2 drops of peppermint oil to each area transdermally with their fingertip at 8:00 a.m. and 8:00 p.m. This application will be performed twice daily by the patient for 2 weeks. For areas inaccessible to the patient, a relative/caregiver will apply 2 drops of peppermint oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and questions answered during the first dose application

  • sweet almond oilOther

    Patients in this group will be introduced to the six sensitive areas where pain is felt, and the locations will be identified with the patient. The patient will apply 2 drops of sweet almond oil to each sensitive area twice daily, at 8:00 a.m. and 8:00 p.m., using their fingertip. This application will be performed twice daily by the patient for 2 weeks. For sensitive areas that the patient cannot access, a family member/caregiver will apply 2 drops of sweet almond oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and their questions answered during the first dose administration. Sweet almond oil will be provided to patients in dark-coloured glass bottles with droppers and secure caps that open with firm pressure. Patients will be advised to store sweet almond oil at room temperature.

  • DuloxetineOther

    Patients in this group will receive treatment planned by a rheumatologist. The pharmacological treatment plan will involve administering duloxetine 60 mg once daily for two weeks, a serotonin-noradrenaline reuptake inhibitor effective on descending pain inhibition pathways in fibromyalgia.

Study groups in NCT07326163
Study groupRoleWhat they receive
peppermint oilExperimentalThis group of patients will be introduced to the tender points where chronic pain is detected in fibromyalgia patients, and the areas where these tender points are located will be divided into six regions, which will be identified with the patient. Subsequently, one drop of peppermint oil will be applied transdermally to the inner surface of the patient's forearm, and the application site will be monitored for allergic reactions such as redness or swelling. Patients who do not report any allergic reactions will apply 2 drops of peppermint oil to each area transdermally with their fingertip at 8:00 a.m. and 8:00 p.m. This application will be performed twice daily by the patient for 2 weeks. For areas inaccessible to the patient, a relative/caregiver will apply 2 drops of peppermint oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and questions answered during the first dose application
Receives: Other: Peppermint Oil
sweet almond oilActive comparatorPatients in this group will be introduced to the six sensitive areas where pain is felt, and the locations will be identified with the patient. The patient will apply 2 drops of sweet almond oil to each sensitive area twice daily, at 8:00 a.m. and 8:00 p.m., using their fingertip. This application will be performed twice daily by the patient for 2 weeks. For sensitive areas that the patient cannot access, a family member/caregiver will apply 2 drops of sweet almond oil. The first dose will be administered by the researcher, who will demonstrate the application to the patient. The patient's opinions will be sought and their questions answered during the first dose administration. Sweet almond oil will be provided to patients in dark-coloured glass bottles with droppers and secure caps that open with firm pressure. Patients will be advised to store sweet almond oil at room temperature.
Receives: Other: sweet almond oil
DuloxetineOtherPatients in this group will receive treatment planned by a rheumatologist. The pharmacological treatment plan will involve administering duloxetine 60 mg once daily for two weeks, a serotonin-noradrenaline reuptake inhibitor effective on descending pain inhibition pathways in fibromyalgia.
Receives: Other: Duloxetine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Scale

    The visual analogue scale is a commonly used pain assessment tool due to its ease of application, reliability, and sensitivity. It consists of a horizontal line measuring 10 cm in length, with the left end labelled 'no pain' and the right end labelled 'severe pain'. The patient is asked to mark the point on this line that best represents their pain intensity, and then the distance between the patient's mark and the left end is measured. This distance, usually measured in millimetres, is interpreted as a 'score'.

    Measured: 2 weeks

  2. The short-form McGill Pain Questionnaire

    This scale consists of three sections; the first section contains 15 word groups for describing pain. Eleven of these words assess the sensory dimension of pain, while four assess the perceptual dimension. These descriptive words are rated on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). In the first section of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score, and total pain score. The second section contains six word groups ranging from 'no pain' to 'unbearable pain' to determine the severity of the pain. In the third section, the patient's current pain intensity is assessed using a visual analogue scale.

    Measured: 2 weeks

  3. The Revised Fibromyalgia Impact Questionnaire (FIQR)

    The Fibromyalgia Impact Questionnaire consists of 21 separate questions. All questions are based on an 11-point numerical rating scale ranging from 0 to 10; 10 indicates the worst possible situation, while 0 means no complaint. The questionnaire consists of three subscales: function, overall impact, and symptoms. The function subscale contains 9 questions, the overall impact subscale contains 2 questions, and the symptoms subscale contains 10 questions. The total score obtained from the items related to function (range 0 to 90) is divided by 3, the total score for general impact (range 0 to 20) remains unchanged as it is divided by 1, and the total score for symptoms (range 0 to 100) is divided by 2 for calculation.

    Measured: 2 weeks

  4. Collection of Cost Data from the Perspective of the Reimbursement Agency (Social Security Institution)

    Costs from the perspective of the reimbursement agency for patients diagnosed with fibromyalgia who receive pharmacological treatment and treatment with aromatherapy oils will be determined through clinical, administrative, and financial records obtained from the hospital's billing, materials management, pharmacy, purchasing, information processing, and statistics departments. Each expense item related to treatments will be classified in detail through detailed invoice breakdowns obtained from the relevant units. Detailed expenditure items related to treatment methods will be expressed through tables.

    Measured: 2 weeks

  5. Collection of Cost Data from the Direct Patient Cost Perspective

    A questionnaire prepared using the literature will be used to determine costs from the direct patient cost perspective. Using this form, called the direct patient cost questionnaire, expenses such as consultation, aromatherapy oils, medication, transportation, nutrition, bed, accommodation and other items (clothing, cleaning supplies, etc.) will be collected for each patient. Tables showing all expense items will be prepared based on the cost data obtained.

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2026
  2. Study start1 Mar 2026
  3. Primary completion30 Dec 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
175 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07326163
Sponsor's protocol ID
Fibromyalgia
Status last verified
Jan 2026
First submitted
24 Dec 2025
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Peppermint Oil, sweet almond oil and Duloxetine in people with Fibromyalgia and Aromatherapy, run by Bilecik Seyh Edebali Universitesi 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 4 inclusion and 12 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 2026. 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?

This study is still under way. Results are not available in the source record yet.

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: 2 weeks). The study lists 5 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 17 Sep 2026.

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