Diabetes MellitusNCT04906226
Effect of Self-Foot Massage on Diabetic Individuals
A study testing Self-foot massage in people with Diabetes Mellitus, run by Aksaray University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Self-foot massage
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2021to 30 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or above,
- Having been diagnosed with type 2 diabetes at least 6 months ago,
- HbA1c level> 6.5%,
- Being able to do personal care for personal hygiene management,
- No peripheral circulation problems,
- Do not have any problems such as speech or hearing that prevent communication,
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- Physical and cognitive health levels are suitable for answering the data collection form,
- Agreeing to participate in the research,
- It is planned to include patients who can speak and understand Turkish.
Who cannot join
- Individuals with other health problems that may cause peripheral neuropathy (chemotherapy, neurological, etc.),
- Patients with organ damage (gangrene or foot / finger amputation) due to diabetes mellitus or any other reason, malignancy, tuberculosis, asthma, or any contagious disease,
- Individuals with a history of disease that may cause changes in peripheral skin temperature (Raynaud's disease, etc.)
- Who do not agree to participate in the research,
- Speaking and hearing impairments that interfere with the collection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Self-Foot Massage on Peripheral Neuropathic Pain, Peripheral Skin Temperature and Patient Comfort in Diabetic Individuals: A Randomized Controlled Trial
The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes.
Read the detailed description
Diabetes mellitus (DM) is the most important metabolic disease that can affect almost every organ system in the body. Although diabetes causes many macrovascular and microvascular complications, one of the rare microvascular complications is peripheral neuropathy. One of the common complementary and integrative applications in the management of diabetic peripheral neuropathy is foot massage. The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. In the collection of data, "Individual Description Form, Visuel Analog Scale- (VAS), DN4 Pain Questionnaire and General Comfort Questionnaire- Short form" will be used. In addition, peripheral skin temperature will be measured with a skin thermometer.
- Conditions
- Diabetes Mellitus
- Being tested
- Self-foot massage
- Keywords
- Type 2 diabetes, Foot massage, Neuropathic pain, Skin temperature, Comfort
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-foot massageBehavioural
The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled. Receives: Behavioral: Self-foot massage |
| Control group | No intervention | There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visuel Analog Scale- (VAS)
The Visual Analogue Scale (VAS), which is used for the assessment of pain, is used to convert some values that cannot be measured numerically into numerical ones.
Measured: 1 months
DN4 Pain Questionnaire
The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.
Measured: 1 months
General Comfort Questionnaire- Short form
It is used to determine the comfort level of patients.
Measured: 1 months
Peripheral skin temperature will be measured with a skin thermometer
The skin temperature in the middle of the plantar surfaces of both feet is measured using the handheld digital skin thermometer.
Measured: 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Aug 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KADRİYE SAYIN KASAR, Aksaray University
- Investigators
- Kadriye SAYIN KASAR, PhD, RN, Principal investigator, Aksaray University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906226
- Sponsor's protocol ID
- 2021-020
- Status last verified
- Jan 2023
- First submitted
- 24 May 2021
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Self-Foot Massage on Peripheral Neuropathic Pain, Peripheral Skin Temperature and Patient Comfort in Diabetic Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04906226
- Acronym / sponsor ID
- 2021-020
- Conditions
- Diabetes Mellitus
- Keywords
- Type 2 diabetes, Foot massage, Neuropathic pain, Skin temperature, Comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Aksaray UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 28 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes.
Detailed description
Diabetes mellitus (DM) is the most important metabolic disease that can affect almost every organ system in the body. Although diabetes causes many macrovascular and microvascular complications, one of the rare microvascular complications is peripheral neuropathy. One of the common complementary and integrative applications in the management of diabetic peripheral neuropathy is foot massage. The aim of this study is to evaluate the effect of self-foot massage on peripheral neuropathic pain, peripheral skin temperature and patient comfort in individuals with diabetes. Individuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. In the collection of data, "Individual Description Form, Visuel Analog Scale- (VAS), DN4 Pain Questionnaire and General Comfort Questionnaire- Short form" will be used. In addition, peripheral skin temperature will be measured with a skin thermometer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Self-foot massageIndividuals participating in the study will be divided into intervention and control groups. The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled. |
| Control group | No intervention | –There will be no additional application other than routine to the control group, data collection forms will be applied and recorded at the beginning of the study and at the end of four weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 18 years of age or above,
- Having been diagnosed with type 2 diabetes at least 6 months ago,
- HbA1c level> 6.5%,
- Being able to do personal care for personal hygiene management,
- No peripheral circulation problems,
Key exclusion criteria (5 listed)
- Individuals with other health problems that may cause peripheral neuropathy (chemotherapy, neurological, etc.),
- Patients with organ damage (gangrene or foot / finger amputation) due to diabetes mellitus or any other reason, malignancy, tuberculosis, asthma, or any contagious disease,
- Individuals with a history of disease that may cause changes in peripheral skin temperature (Raynaud's disease, etc.)
- Who do not agree to participate in the research,
- Speaking and hearing impairments that interfere with the collection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-foot massageThe individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled. | Behavioural | Intervention group |
Primary outcome
Visuel Analog Scale- (VAS)
Time frame: 1 months
The Visual Analogue Scale (VAS), which is used for the assessment of pain, is used to convert some values that cannot be measured numerically into numerical ones.
DN4 Pain Questionnaire
Time frame: 1 months
The DN4 pain questionnaire is a questionnaire that includes symptoms and signs associated with neuropathic pain.
General Comfort Questionnaire- Short form
Time frame: 1 months
It is used to determine the comfort level of patients.
Peripheral skin temperature will be measured with a skin thermometer
Time frame: 1 months
The skin temperature in the middle of the plantar surfaces of both feet is measured using the handheld digital skin thermometer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kadriye SAYIN KASAR, PhD, RN principal investigator
Aksaray University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-foot massage in people with Diabetes Mellitus, run by Aksaray University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visuel Analog Scale- (VAS) (time frame: 1 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.