Clinical trial NCT05647083: The Effect of Massage on Diabetic Parameters
Official title: The Effect of Massage on Diabetic Foot Risk, HbA1c and Physiological Parameters in People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Peripheral Neuropathy
Keywords: massage
glycemic control
diabetic foot risk
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 55
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This research aims to investigate the effect of massage on diabetic foot risk, HbA1c and physiological parameters in individuals with type 2 diabetes. This randomized controlled experimental design will be carried out in Bolu Izzet Baysal State Hospital Köroğlu Unit Internal Medicine Polyclinic and Internal Medicine Service. According to power analysis, the minimum sample size was determined as 60 people, 30 of which were in the intervention group and 30 in the control group. Data collection tools include "Peripheral Neuropathy Sign and Symptom Score", "Ankle-Brachial Index (ABI)", "Glycemic Control Assessment (HbA1c)", "Physiological Parameters (blood pressure, heart rate and oxygen saturation)", "Inlow's 60-second Diabetic Food Screen". A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Participants in the control group will continue their medical treatment protocols and massage will not be applied.


Eligibility criteria: Inclusion Criteria:

* Being between 30-75 years old,
* Diagnosed with diabetes at least 6 months ago,
* Absence of irritation, ulceration in the areas where the massage will be applied (hands, feet and legs),
* No problem in verbal communication,
* Being able to speak Turkish,
* No diagnosis of psychiatric disease,
* Absence of amputation in the upper and lower extremities,
* Having HbA1c test results in the last 1 week,
* Not having had Covid-19 in the last 6 months
* No experience of massage application in the last 1 month
* Willingness to participate in the research

Exclusion Criteria:

* Presence of diabetic ulcer and foot wound,
* Irritation and ulceration in the areas where the massage will be applied (hands, feet and legs),
* Having problems in verbal communication,
* Not being able to speak Turkish,
* Having a diagnosis of psychiatric illness.

Primary outcomes:
measure: Means of Peripheral Neuropathy Sign and Symptom Score
timeFrame: Change from baseline Neuropathy score at 3 months
measure: Means of Ankle-Brachial Index Score
timeFrame: Change from baseline Ankle-Brachial Index score at 3 months
measure: Means of HbA1c (%)
timeFrame: Change from baseline HbA1c score at 3 months
measure: Means of systolic blood pressure (mmHg)
timeFrame: Change from baseline systolic blood pressure at 3 months
measure: Means of diastolic blood pressure (mmHg)
timeFrame: Change from baseline diastolic blood pressure at 3 months
measure: Means of heart rate (/minutes)
timeFrame: Change from baseline heart rate at 3 months
measure: Means of oxygen saturation (%)
timeFrame: Change from baseline oxygen saturation at 3 months
measure: Means of diabetic foot risk score
timeFrame: Change from baseline diabetic foot risk score at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital
Study officials:
affiliation: Abant Izzet Baysal University
name: Elif Gençer Şendur, MSC
role: PRINCIPAL_INVESTIGATOR
References: