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The Effect of Massage on Diabetic Parameters

Primary Purpose

Diabetes Mellitus, Type 2, Peripheral Neuropathy

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Massage therapy
Sponsored by
Abant Izzet Baysal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring massage, glycemic control, diabetic foot risk

Eligibility Criteria

30 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bolu Provincial Health Directorate Bolu Izzet Baysal State HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage.

Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods.

Outcomes

Primary Outcome Measures

Means of Peripheral Neuropathy Sign and Symptom Score
Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score; Discomfort they feel in their feet, Location of complaints, The presence of complaints increases at night, Time of occurrence of complaints and 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, "normal"; 3-4 points, "mild neuropathy"; 5-6 points, "moderate neuropathy"; A score of 7-9 will be considered "severe neuropathy". For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination
Means of Ankle-Brachial Index Score
It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1.
Means of HbA1c (%)
HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later.
Means of systolic blood pressure (mmHg)
It will be measured by the researcher with a manual measurement tool.
Means of diastolic blood pressure (mmHg)
It will be measured by the researcher with a manual measurement tool.
Means of heart rate (/minutes)
It will be measured by the researcher with a pulse oximeter.
Means of oxygen saturation (%)
It will be measured by the researcher with a pulse oximeter.
Means of diabetic foot risk score
"Inlow's 60-second Diabetic Food Screen" form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2022
Last Updated
December 2, 2022
Sponsor
Abant Izzet Baysal University
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1. Study Identification

Unique Protocol Identification Number
NCT05647083
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Abant Izzet Baysal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Peripheral Neuropathy
Keywords
massage, glycemic control, diabetic foot risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
A total of 24 massage sessions will be applied to the intervention group, 2 times a week during the 12-week working period. Sesame oil will be used as the main oil in the massage application. Massage times are recommended as 10-15 minutes for upper extremity massage and 15-20 minutes for lower extremity massage.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group will continue their medical treatment protocols and massage will not be applied. Measurement tools and physiological measurements will be evaluated at the frequency specified in the intervention group, using the same measurement tools and the same measurement methods.
Intervention Type
Other
Intervention Name(s)
Massage therapy
Intervention Description
Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.
Primary Outcome Measure Information:
Title
Means of Peripheral Neuropathy Sign and Symptom Score
Description
Peripheral neuropathy consists of two parts: symptom and symptom score. For the peripheral neuropathy symptom score; Discomfort they feel in their feet, Location of complaints, The presence of complaints increases at night, Time of occurrence of complaints and 5 questions will be asked about how the complaints decreased. Peripheral neuropathy symptom score obtained from 5 questions was 0-2 points, "normal"; 3-4 points, "mild neuropathy"; 5-6 points, "moderate neuropathy"; A score of 7-9 will be considered "severe neuropathy". For peripheral neuropathy finding score; It will be determined based on four parameters including 1. Vibration sense, 2. Pimpiric test, 3. Achille tendon reflex, 4. Protective sensory examination
Time Frame
Change from baseline Neuropathy score at 3 months
Title
Means of Ankle-Brachial Index Score
Description
It is calculated by dividing the tibialis posterior pressure by the brachial arterial pressure. The highest of the four measurements at the ankles and feet is divided by the two higher brachial measurements. The normal value is close to 1.
Time Frame
Change from baseline Ankle-Brachial Index score at 3 months
Title
Means of HbA1c (%)
Description
HbA1c values of the participants will be monitored as a glycemic control parameter. The HbA1c value will be evaluated at baseline and 3 months later, as it represents the three-month average blood glucose value. For the measurement of HbA1c, the test results within the last week will be taken from the participants at the beginning and a blood sample will be taken into ethylenediaminetetraacetic acid (EDTA) coated tubes (2 mL whole) by a nurse three months later.
Time Frame
Change from baseline HbA1c score at 3 months
Title
Means of systolic blood pressure (mmHg)
Description
It will be measured by the researcher with a manual measurement tool.
Time Frame
Change from baseline systolic blood pressure at 3 months
Title
Means of diastolic blood pressure (mmHg)
Description
It will be measured by the researcher with a manual measurement tool.
Time Frame
Change from baseline diastolic blood pressure at 3 months
Title
Means of heart rate (/minutes)
Description
It will be measured by the researcher with a pulse oximeter.
Time Frame
Change from baseline heart rate at 3 months
Title
Means of oxygen saturation (%)
Description
It will be measured by the researcher with a pulse oximeter.
Time Frame
Change from baseline oxygen saturation at 3 months
Title
Means of diabetic foot risk score
Description
"Inlow's 60-second Diabetic Food Screen" form will be used in diabetes foot risk assessment. Diabetic foot examination consists of 12 parameters. Skin Assessment, Evaluation of Nail Structure, deformity, Evaluation of the Shoe, Heat Evaluation - Being Cold, Heat Evaluation - Being Hot, Range of Motion Evaluation, Sensory Evaluation, Sensory Evaluation (Assessment with questions directed to individuals), Evaluation of Pedal Pulses, Dependent Rubor Evaluation, Evaluation of Erythema (Redness). The minimum score to be taken from the foot examination form is evaluated as 0 and the maximum score as 23 points. The higher the score, the higher the risk of diabetic foot.
Time Frame
Change from baseline diabetic foot risk score at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
hospital Chief Physician, Dr
Phone
0 374 270 45 75
Email
boludhs3.info@saglik.gov.tr
First Name & Middle Initial & Last Name or Official Title & Degree
Saadet Can Çiçek, Dr
Phone
05062846936
Email
saadet.cancicek@ibu.edu.tr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elif Gençer Şendur, MSC
Organizational Affiliation
Abant Izzet Baysal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital
City
Bolu
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
hospitalChief Physician Dr, Dr
Phone
0 374 270 45 75
Ext
1100
Email
bolueah1@saglik.gov.tr

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Massage on Diabetic Parameters

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