The Effect of Aromatherapy Foot Massage on Neuropathic Pain in Patients With Type2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTC Erciyes University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
intervention I group
Other intervention'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
Other interventionWhen 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.
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: aromatherapy foot massageExperimental treatment 1 intervention
Group B: foot massageExperimental treatment 1 intervention
Group C: Control GroupNo intervention 0 interventions
Trial outcomes
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.
Time frame
4 weeksSecondary outcomes
1
DOULEUR NEUROPATHIC PAIN QUESTIONNAIRE (DN4)
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.
Time frame
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, 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.
Time frame
The scale will be applied at the first match and at the end of the 4th week.Sponsors and contacts
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Source ClinicalTrials.gov
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