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

NCT ID: NCT07271160

Last Updated: 2025-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2026-05-15

Brief Summary

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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:

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.

Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus (T2DM) Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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aromatherapy foot massage

'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.

Group Type EXPERIMENTAL

intervention I group

Intervention Type OTHER

'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.

foot massage

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 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.

Group Type EXPERIMENTAL

Intervention II group

Intervention Type OTHER

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.

Control Group

No 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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intervention I 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 Type OTHER

Intervention II group

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.

Intervention Type OTHER

Other Intervention Names

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intervention II group intervention II

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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TC Erciyes University

OTHER

Sponsor Role lead

Responsible Party

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Özlem Ceyhan

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Özlem Ceyhan, Associate Professor

Role: STUDY_DIRECTOR

TC Erciyes University

Locations

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Nevsehir State Hospital

Nevşehir, Nevşehir Province, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Özlem Ceyhan, Assoc.Prof.

Role: CONTACT

+903522076666 ext. 28561

Fatma Buruntekin, MSc

Role: CONTACT

+905068134205 ext. +905068134205

Facility Contacts

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Fatma Buruntekin, MSc

Role: primary

+905068134205 ext. +905068134205

Fatma Buruntekin, MSc

Role: backup

+903842285050 ext. 1292

References

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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.

Reference Type BACKGROUND
PMID: 37175176 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32470476 (View on PubMed)

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.

Reference Type RESULT
PMID: 34217127 (View on PubMed)

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.

Reference Type RESULT
PMID: 28605119 (View on PubMed)

Related Links

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https://www.nccih.nih.gov/health/aromatherapy

National Center for Complementary and Integrative Health

Other Identifiers

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aromatherapy foot massage

Identifier Type: -

Identifier Source: org_study_id

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