Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2026-01-26 @ 1:12 AM
Study NCT ID:
NCT07271160
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-09
First Post:
2025-02-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D009437', 'term': 'Neuralgia'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 78}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-05-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-07', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-12-07', 'lastUpdatePostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'PAIN-ACTIVITY PATTERNS SCALE (POAM-P/ AAPÖ)', 'timeFrame': 'The scale will be applied at the first match and at the end of the 4th week.', 'description': "The scale, which was first developed by Cane et al. (2013) and the Turkish validity and reliability of which was performed by Emine Tunç Süygün (2019), consists of 3 subgroups, namely avoidance, overdoing, and regularisation, and a total of 30 questions, 10 for each subgroup. In the scale, 'Individuals with chronic pain use different ways to do their daily activities. Think about how you usually do your daily activities. For each of the following statements, circle the numbers between 0 and 4 that best describe how you usually do your daily activities'. In answering the scale, a 5-point Likert scoring system is used, 0-never 2-sometimes 4-always. For the sub-groups of avoidance, overdoing and regularisation, the answers given to the questions belonging to the groups are summed separately and the participant's 3 separate sub-group scores are obtained. The total scores calculated for the subgroups vary between 0-40 points separately."}], 'primaryOutcomes': [{'measure': 'McGILL PAIN SURVEY SHORT FORM (SF-MPQ)', 'timeFrame': '4 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4)', 'timeFrame': 'The scale will be applied at the first match and at the end of the 4th week.', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neuropathic pain', 'type 2 diabetes', 'aromatherapic massage'], 'conditions': ['Type 2 Diabetes Mellitus (T2DM)', 'Neuropathic Pain']}, 'referencesModule': {'references': [{'pmid': '37175176', 'type': 'BACKGROUND', 'citation': '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': '32470476', 'type': 'BACKGROUND', 'citation': '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': '34217127', 'type': 'RESULT', 'citation': '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': '28605119', 'type': 'RESULT', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.nccih.nih.gov/health/aromatherapy', 'label': 'National Center for Complementary and Integrative Health'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe main questions he aimed to answer are as follows:\n\nDoes 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.\n\nParticipants:\n\nParticipants 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.', 'detailedDescription': '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.\n\nIn 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.\n\nDiabetic 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a Douleur neuropathic pain questionnaire score of 4 and above,\n* 18 years and over,\n* No psychiatric illness,\n* Patients who are able to answer all the questions,\n* Turkish-speaking patients.\n\nExclusion Criteria:\n\n* Patients who cannot be contacted,\n* Any limb, vascular problem or wound that prevents the application of foot massage,\n* Thrombophlebitis, occlusive arterial disease, fever, etc. Those who are inconvenient to massage due to illness,\n* Patients who refused to participate in the study.'}, 'identificationModule': {'nctId': 'NCT07271160', 'briefTitle': 'The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'TC Erciyes University'}, 'officialTitle': 'The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes', 'orgStudyIdInfo': {'id': 'aromatherapy foot massage'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'aromatherapy foot massage', 'description': '\'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.\n\nThe \'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.', 'interventionNames': ['Other: intervention I group']}, {'type': 'EXPERIMENTAL', 'label': 'foot massage', 'description': "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.\n\nThe '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.", 'interventionNames': ['Other: Intervention II group']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "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.\n\n'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."}], 'interventions': [{'name': 'intervention I group', 'type': 'OTHER', 'otherNames': ['intervention II group'], 'description': "'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.", 'armGroupLabels': ['aromatherapy foot massage']}, {'name': 'Intervention II group', 'type': 'OTHER', 'otherNames': ['intervention II'], 'description': "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.", 'armGroupLabels': ['foot massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50100', 'city': 'Nevşehir', 'state': 'Nevşehir Province', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Fatma Buruntekin, MSc', 'role': 'CONTACT', 'email': 'fburuntekin@gmail.com', 'phone': '+905068134205', 'phoneExt': '+905068134205'}, {'name': 'Fatma Buruntekin, MSc', 'role': 'CONTACT', 'email': 'fburuntekin@gmail.com', 'phone': '+903842285050', 'phoneExt': '1292'}, {'name': 'Fatma Buruntekin, MSc', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nevsehir State Hospital', 'geoPoint': {'lat': 38.625, 'lon': 34.71222}}], 'centralContacts': [{'name': 'Özlem Ceyhan, Assoc.Prof.', 'role': 'CONTACT', 'email': 'ozlemg@erciyes.edu.tr', 'phone': '+903522076666', 'phoneExt': '28561'}, {'name': 'Fatma Buruntekin, MSc', 'role': 'CONTACT', 'email': 'fburuntekin@gmail.com', 'phone': '+905068134205', 'phoneExt': '+905068134205'}], 'overallOfficials': [{'name': 'Özlem Ceyhan, Associate Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'TC Erciyes University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'individual patient data will only be used within the scope of the study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TC Erciyes University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Özlem Ceyhan', 'investigatorAffiliation': 'TC Erciyes University'}}}}