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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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
• Другое 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

Первичные конечные точки

• McGILL PAIN SURVEY SHORT FORM (SF-MPQ) [Срок оценки: 4 weeks]

Вторичные конечные точки (1)

• DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4) [Срок оценки: The scale will be applied at the first match and at the end of the 4th week.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Nevsehir State Hospital — Nevşehir

Публикации

• 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. PMID 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. PMID 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. PMID 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. PMID 28605119

Идентификаторы

NCT: NCT07271160 · aromatherapy foot massage

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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