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Type 2 Diabetes Mellitus (T2DM)NCT07271160

The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes

A study testing intervention I group and Intervention II group in people with Type 2 Diabetes Mellitus (T2DM) and Neuropathic Pain, run by TC Erciyes University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The aim of this clinical trial is to learn about the effect of aromatherapy foot massage on neuropathic pain in patients with Type 2 diabetes. In addition, while determining the effect of aromatherapy foot massage on neuropathic pain; it was also aimed to find the source of the reduction in pain. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
intervention I group and Intervention II group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Dec 2025to 15 May 2026
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

  • Patients with a Douleur neuropathic pain questionnaire score of 4 and above,
  • 18 years and over,
  • No psychiatric illness,
  • Patients who are able to answer all the questions,
  • Turkish-speaking patients.

Who cannot join

  • Patients who cannot be contacted,
  • Any limb, vascular problem or wound that prevents the application of foot massage,
  • Thrombophlebitis, occlusive arterial disease, fever, etc. Those who are inconvenient to massage due to illness,
  • Patients who refused to participate in the study.

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
  • Nevsehir State Hospital

    Nevşehir, Nevşehir Province, 50100

    Fatma Buruntekin, MSc, +905068134205 ext. +905068134205, fburuntekin@gmail.com

    Fatma Buruntekin, MSc, +903842285050 ext. 1292, fburuntekin@gmail.com

Other trials in Turkey (Türkiye)

About this study

The aim of this clinical trial is to learn about the effect of aromatherapy foot massage on neuropathic pain in patients with Type 2 diabetes. In addition, while determining the effect of aromatherapy foot massage on neuropathic pain; it was also aimed to find the source of the reduction in pain.

The main questions he aimed to answer are as follows:

Read more

Does aromatherapy foot massage have an effect on neuropathic pain in patients with type 2 diabetes? Does foot massage have an effect on neuropathic pain in patients with type 2 diabetes? The researchers will compare an oil without aromatherapy oil with a placebo group to see if aromatherapy foot massage reduces neuropathic pain.

Participants:

Participants will perform the massage treatment three times a week for 4 weeks. Participants will perform foot massage for 10 minutes, 5 minutes on each foot. Participants will be evaluated by calling once a week for 4 weeks.

Read the detailed description

Up to half of diabetic patients suffer from a complication known as diabetic neuropathy, which affects both the autonomic and peripheral nervous systems, with particular damage to the lower extremities. Diabetic neuropathy affects the peripheral sensory nerve endings of the hands and lower extremities, causing pain, numbness, burning and tingling sensations. Symptoms such as pain and burning experienced by diabetics cause a decrease in quality of life. In addition, the risk of ulceration in the feet is more than 15% and the risk of amputation is 15 times higher than non-diabetic individuals. Although diabetic neuropathy is one of the most serious complications of diabetes, its treatment is symptomatic.

In the presence of pain, complementary and integrative therapies such as opioid and non-opioid drugs, surgical methods, manual therapies and various mind-body practices are applied. Massage, one of these methods, is performed by manipulation of the soft tissues of the body. However, massage has the advantages of being applicable to almost every part of the body, not requiring any special equipment and not causing any serious complications. Another method, aromatherapy, uses natural plant extracts known as essential oils to improve physical, mental and emotional health. These essential oils are extracted from various parts of plants, including flowers, leaves, stems, roots and fruits. Aromatherapy oils can be inhaled as inhalers or applied to the skin through massage, baths or compresses. Physiological and pathophysiological benefits of aromatherapy oils on the nervous system have also been supported by studies.

Diabetic neuropathic pain has been associated with mental comorbidity, sleep disorders, more diabetes complications and lower quality of life. Therefore, it is essential to effectively manage pain in diabetic neuropathy and improve the quality of life of the individual. In a study examining the effects of aromatherapy massage on neuropathic pain severity and quality of life; it was found that neuropathic pain scores and quality of life scores improved significantly in the intervention group compared to the control group. In this study, it was not specified whether the reduction in neuropathic pain was the result of massage therapy or a specific essential oil in the aromatherapy mixture, since no intervention was performed in the control group. In our study; while determining the effect of aromatherapy foot massage on neuropathic pain; it was aimed to find the source of the reduction in pain.

Being tested
intervention I group, Intervention II group
Keywords
neuropathic pain, type 2 diabetes, aromatherapic massage
Medical subject headings
Diabetes Mellitus, Type 2, Neuralgia

What participants receive

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

  • intervention I groupOther

    Also called intervention II group

    'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be applied through face-to-face interview and the first aromatherapy foot massage will be applied when the patients in the intervention I group first arrive. Patients will be asked to massage their right foot for five minutes and their left foot for five minutes before going to bed three days a week (Monday-Wednesday-Friday) for a total of ten minutes in accordance with the foot massage application protocol. 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be administered again by telephone or face-to-face interview.

  • Intervention II groupOther

    Also called intervention II

    When the patients in the Intervention II group first arrive, the 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be applied through face-to-face interview and the first foot massage with sesame oil will be applied. Patients will be asked to massage their right foot for five minutes and their left foot for five minutes before going to bed three days a week (Monday-Wednesday-Friday) for a total of ten minutes in accordance with the foot massage application protocol. 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns Scale' will be administered again by telephone or face-to-face interview.

Study groups in NCT07271160
Study groupRoleWhat they receive
aromatherapy foot massageExperimental'Patient Introduction Form', "DN4 neuropathic pain questionnaire", "Mcgill pain questionnaire short form" and "Pain-Activity Patterns scale" will be applied through face-to-face interview and the first aromatherapy foot massage will be applied when the patients in the intervention I group first arrive. Patients will be asked to massage the right foot for five minutes and the left foot for five minutes for a total of ten minutes before going to bed three days a week (Monday-Wednesday-Friday) in accordance with the foot massage application protocol. The 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.
Receives: Other: intervention I group
foot massageExperimentalWhen the patients in the Intervention II group first arrive, the 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied through face-to-face interview and the first foot massage with sesame oil will be applied. Patients will be asked to massage the right foot for five minutes and the left foot for five minutes for a total of ten minutes before going to bed three days a week (Monday-Wednesday-Friday) in accordance with the foot massage application protocol. The 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.
Receives: Other: Intervention II group
Control GroupNo interventionNo application will be made to the control group, 'Patient Introduction Form', 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be collected by face-to-face interview. 'Mcgill pain questionnaire short form' will be administered to the patients every week on Saturday at the same time by telephone. At the end of the fourth week, 'DN4 neuropathic pain questionnaire', 'Mcgill pain questionnaire short form' and 'Pain-Activity Patterns scale' will be applied again by telephone or face-to-face interview.

What is being measured

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

  1. McGILL PAIN SURVEY SHORT FORM (SF-MPQ)

    The scale, which was first developed by Melzack (1987) and validated in Turkish by Yakut et al. (2006), includes 15 descriptive word groups including the characteristics of pain. Eleven of them evaluate the sensory dimension of pain and four of them evaluate the perceptual dimension of pain. These descriptive words are graded on an intensity scale from 0 to 3 (0 = none, 1 = mild, 2 = moderate, 3 = severe). In the first part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score. Sensory pain score is between 0-33, perceptual pain score is between 0-12 and total pain score is between 0-45. An increase in the score indicates an increase in pain.

    Measured: 4 weeks

Secondary outcomes (1)
  1. DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4)

    The scale, which was developed by a French expert group (2005) and validated by Ünal Çevik et al. (2010) in Turkish, consists of 10 items. The first 7 items are related to pain characteristics and sensations and the remaining 3 items are related to examination. A score of '1' is given if the answer is 'yes' and '0' if the answer is 'no'. If the sum of all 10 items is calculated as 4 or more, the patient is defined as having neuropathic pain.

    Measured: The scale will be applied at the first match and at the end of the 4th week.

Timeline

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

  1. First posted9 Dec 2025
  2. Study start1 Dec 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion15 May 2026 (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
Model description
Patients in the Intervention I group will receive aromatherapy foot massage. Patients in the Intervention II group will receive massage with sesame oil. The control group will not receive any application other than treatments.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07271160
Sponsor's protocol ID
aromatherapy foot massage
Status last verified
Dec 2025
First submitted
27 Feb 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: individual patient data will only be used within the scope of the study.

Publications

  • Sattayakhom A, Wichit S, Koomhin P. The Effects of Essential Oils on the Nervous System: A Scoping Review. Molecules. 2023 Apr 27;28(9):3771. doi: 10.3390/molecules28093771.

    PubMed 37175176
  • Naranjo C, Ortega-Jimenez P, Del Reguero L, Moratalla G, Failde I. Relationship between diabetic neuropathic pain and comorbidity. Their impact on pain intensity, diabetes complications and quality of life in patients with type-2 diabetes mellitus. Diabetes Res Clin Pract. 2020 Jul;165:108236. doi: 10.1016/j.diabres.2020.108236. Epub 2020 May 26.

    PubMed 32470476
  • Rivaz M, Rahpeima M, Khademian Z, Dabbaghmanesh MH. The effects of aromatherapy massage with lavender essential oil on neuropathic pain and quality of life in diabetic patients: A randomized clinical trial. Complement Ther Clin Pract. 2021 Aug;44:101430. doi: 10.1016/j.ctcp.2021.101430. Epub 2021 Jun 18.

    PubMed 34217127
  • Gok Metin Z, Arikan Donmez A, Izgu N, Ozdemir L, Arslan IE. Aromatherapy Massage for Neuropathic Pain and Quality of Life in Diabetic Patients. J Nurs Scholarsh. 2017 Jul;49(4):379-388. doi: 10.1111/jnu.12300. Epub 2017 Jun 12.

    PubMed 28605119

Questions about this trial

What is this clinical trial studying?

A study testing intervention I group and Intervention II group in people with Type 2 Diabetes Mellitus (T2DM) and Neuropathic Pain, run by TC Erciyes 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 5 inclusion and 4 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: opening soon, as of the sponsor's last update on 9 Dec 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?

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?

Contact Özlem Ceyhan, Assoc.Prof. (+903522076666 ext. 28561, ozlemg@erciyes.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

McGILL PAIN SURVEY SHORT FORM (SF-MPQ) (time frame: 4 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07271160, which also lists 4 linked publications.

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 9 Dec 2025.

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