The Effect of Massage on Diabetic Parameters

NCT ID: NCT05647083

Last Updated: 2024-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-09

Study Completion Date

2024-02-09

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention group

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.

Group Type EXPERIMENTAL

Massage therapy

Intervention Type OTHER

Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Massage therapy

Classical massage will be applied to the hands and feet, which is expected to take an average of 30 minutes.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Abant Izzet Baysal University

OTHER

Sponsor Role lead

Responsible Party

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Elif Gencer Sendur

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elif Gençer Şendur, MSC

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

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Bolu Provincial Health Directorate Bolu Izzet Baysal State Hospital

Bolu, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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BAIBU-SBF-EGS-2

Identifier Type: -

Identifier Source: org_study_id

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