The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes
NCT ID: NCT07271160
Last Updated: 2025-12-09
Study Results
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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NOT_YET_RECRUITING
NA
78 participants
INTERVENTIONAL
2025-12-01
2026-05-15
Brief Summary
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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.
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
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.
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.
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.
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.
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.
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 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years and over,
* No psychiatric illness,
* Patients who are able to answer all the questions,
* Turkish-speaking patients.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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TC Erciyes University
OTHER
Responsible Party
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Özlem Ceyhan
associate professor
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)
Countries
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Central Contacts
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Facility Contacts
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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.
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.
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.
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.
Related Links
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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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