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

NCT07271160 | Not Yet Recruiting

• 1 other identifier: aromatherapy foot massage
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes Mellitus (T2DM); Neuropathic Pain

Keywords

neuropathic pain; type 2 diabetes; aromatherapic massage

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (1)

• DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4)

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

Other Outcomes (1)

• PAIN-ACTIVITY PATTERNS SCALE (POAM-P/ AAPÖ)

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

Study Arms (3)

aromatherapy foot massage

EXPERIMENTAL

'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.

Other: intervention I group

foot massage

EXPERIMENTAL

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.

Other: Intervention II group

Control Group

NO INTERVENTION

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.

Interventions

intervention I group 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.

Also known as: intervention II group

aromatherapy foot massage

Intervention II group 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.

Also known as: intervention II

foot massage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Nevsehir State Hospital

Nevşehir, Nevşehir Province, 50100, Turkey (Türkiye)

Location

Related Publications (4)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 RESULT

• 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 RESULT

Related Links

• National Center for Complementary and Integrative Health

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Neuralgia

Interventions

Methods

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Özlem Ceyhan, Associate Professor

  TC Erciyes University

  STUDY DIRECTOR

Central Study Contacts

Özlem Ceyhan, Assoc.Prof.

CONTACT

+903522076666; ozlemg@erciyes.edu.tr

Fatma Buruntekin, MSc

CONTACT

+905068134205; fburuntekin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Model Details: 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.

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: December 9, 2025
• Study Start: December 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): May 15, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)