Nursing CariesNCT05630417
Investigation of the Effect of Geriatric Massage
A study testing Feet and Back Massage in people with Nursing Caries, run by Bayburt University at 1 site in Turkey (Türkiye).
Trial summary
There is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and… Read more about this study
- Who is it for?
- Ages 65 to 84 years
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Feet and Back Massage
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 30 Oct 2023
- 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 65 to 84 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age 65-84
- No visual or hearing impairment
- Ability to communicate verbally
- Applying to Bayburt State Hospital Internal Medicine Polyclinic
- Having a diagnosis of Type 2 diabetes for at least six months
- A score of 25 and above on the Standardized Mini Mental Test
- Agreeing to participate in the research
Who cannot join
- Having vascular disease (thrombus, phlebitis, arterial embolism, severe venous ulceration)
- Having heart failure, pacemaker and neurological disease
- Body temperature being higher than 37.5°C for more than two days, suspected or diagnosed with inflammation
- Having acute pain
- Cancer and undiagnosed malignancies, receiving chemotherapy and radiotherapy
- Presence of any scar tissue, chronic inflammatory skin diseases on the back
- Having foot amputation, fracture, infection, wound, skin disease, pathology and neuropathy related to muscles and bones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effect of Geriatric Massage Applied to the Elderly With Type 2 Diabetes on Diabetes Symptoms and Blood Parameters
There is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes. 60 elderly people who type 2 diabetes who applied to the Internal Medicine Polyclinic of Bayburt State Hospital in the city center of Bayburt will the diagnosis of Type 2 diabetes will form the sample of the study. The sample will consist of two groups, the geriatric massage group and the control group. Data will be collected with the "Elderly Information Form", "Standardized Mini-Mental Test", "Diabetes Symptoms Checklist Scale", "Blood Parameters Monitoring Form". "Geriatric Massage" will be applied as an intervention. The geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage and 10 minutes back massage, two days a week for eight weeks. The control group will receive the institution's standard of care. Frequency, number, mean, Student's t test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation and Regression Analysis will be used in the analysis of the data. As a result of this study, it is anticipated that the effects of geriatric massage on diabetes symptoms and blood parameters in the elderly with Type 2 diabetes will be determined and these effects will be included in evidence-based guidelines.
- Conditions
- Nursing Caries
- Being tested
- Feet and Back Massage
- Keywords
- Blood parameters, Elderly, Geriatric massage, Symptom, Type 2 Diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feet and Back MassageOther
Foot massage: Feet are the most neglected organs of people and therefore cause many complaints. Foot massage is a massage applied to the back of the foot, toes, soles of the feet, the muscles between the thumb and little fingers, and the heel, where the muscles between the metatarsal bones are located.
Back massage: Back massage is a non-invasive nursing intervention that can be easily applied by nurses. In back massage application; A 10-minute back massage program applied by Çınar and Eşer (2012) will be applied.
| Study group | Role | What they receive |
|---|---|---|
| Geriatric Massage Group | Experimental | The fragility of the elderly, the sensitivity of skin, muscle and bone tissue necessitate modification of massage techniques according to the individual characteristics of the elderly. Geriatric massage is a form of massage applied according to the characteristics of the elderly individual and can be applied to all body parts according to the needs of the elderly. However, since diabetic neuropathy, which is a long-term complication that is common in individuals with Type 2 diabetes and can affect all body parts, shows more symptoms in the feet, foot massage as a geriatric massage may be effective in reducing diabetes symptoms and improving blood parameters. Because of its more systemic effects, back massage was preferred. Receives: Other: Feet and Back Massage |
| Control Group | No intervention | No attempt will be made by the researcher on the elderly with Type 2 diabetes in the control group. The elderly in this group will benefit from the standard care practices offered by the institution. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Elderly Information Form
This form, which was created by the researchers by scanning the literature, consists of two parts. In the first part, seven questions to determine the introductory characteristics of the elderly (age, gender, marital status, place of residence, education level, occupation, smoking and alcohol use); In the second part, there are a total of 13 questions, six of which are aimed at determining the diabetes characteristics of the elderly (duration of diabetes, type of treatment, regular application of treatment, presence of other chronic diseases, attention to diet, regular exercise).
Measured: First day
Standardized Mini Mental Test (SMMT)
This test consists of "orientation, recording, attention, calculation, reminder, language tests and configuration" sections. Test; It is a test that can be administered by physicians, nurses and psychologists in a short time (10 minutes), outpatient conditions or at the bedside. The test was developed for the purpose of short-term cognitive assessment in the elderly, especially in the examination of delirium or dementia.Each question in the test is worth "1" point. The lowest score that can be obtained from the scale is "0" and the highest score is "30". According to the points received; 0-12 points at "severe" level, 13-22 points at "moderate" level and 23-24 points at "mild" level as "cognitive impairment"; A score between 25 and 30 is considered as "no cognitive impairment".
Measured: will be applied on the first day. If the Standardized Mini Mental Test result is not 25 points or more, the patient will be excluded.]
Diabetes Symptoms Checklist Scale
This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.
Measured: First week
Blood Parameters Follow-up Form
This form was created by the researcher by scanning the literature to record and monitor the blood parameters of the elderly with diabetes. in form; There are seven values including glycosylated hemoglobin (HbA1C/%), fasting plasma glucose (APG/mg/dl), triglyceride (TG/mg/dl), high-density lipoprotein (HDL/mg/dl), low-density lipoprotein (LDL/mg/dl), creatinine mg/dl and urea mg/dl values of the elderly. These seven values are routinely requested from all patients who come to Bayburt State Hospital Internal Medicine Outpatient Clinic with the diagnosis of Type 2 diabetes and the results are recorded in the computer environment. Blood parameter results will be taken from the computer environment and recorded by the researcher.
Measured: First week
Secondary outcomes (4)
Diabetes Symptoms Checklist Scale
This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.
Measured: Forth week
Diabetes Symptoms Checklist Scale
This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.
Measured: Eighth week
Diabetes Symptoms Checklist Scale
This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.
Measured: Twelfth week
Blood Parameters Follow-up Form
This form was created by the researcher by scanning the literature to record and monitor the blood parameters of the elderly with diabetes. in form; There are seven values including glycosylated hemoglobin (HbA1C/%), fasting plasma glucose (APG/mg/dl), triglyceride (TG/mg/dl), high-density lipoprotein (HDL/mg/dl), low-density lipoprotein (LDL/mg/dl), creatinine mg/dl and urea mg/dl values of the elderly. These seven values are routinely requested from all patients who come to Bayburt State Hospital Internal Medicine Outpatient Clinic with the diagnosis of Type 2 diabetes and the results are recorded in the computer environment. Blood parameter results will be taken from the computer environment and recorded by the researcher.
Measured: Twelfth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Mar 2022
- Primary completion30 Aug 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies 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
- The research was planned as a pre test-post test randomized controlled single-center study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayburt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine APAYDIN, Bayburt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630417
- Sponsor's protocol ID
- EAPAYDIN.TEZ-KTÜ
- Status last verified
- Jan 2024
- First submitted
- 17 Nov 2022
- Last updated
- 9 Jan 2024
- 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 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Geriatric Massage Applied to the Elderly With Type 2 Diabetes on Diabetes Symptoms and Blood Parameters
- ClinicalTrials.gov ID
- NCT05630417
- Acronym / sponsor ID
- EAPAYDIN.TEZ-KTÜ
- Conditions
- Nursing Caries
- Keywords
- Blood parameters, Elderly, Geriatric massage, Symptom, Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bayburt UniversityUniversity, hospital or other
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 30 Aug 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 29 Nov 2022 (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.
There is no study has been found to examine the effect of geriatric massage applied to the elderly with type 2 diabetes on diabetes symptoms and blood parameters. This study was planned as a pretest-posttest randomized controlled single-center study to examine the effect of geriatric massage on diabetes symptoms and blood parameters in the elderly with type 2 diabetes. 60 elderly people who type 2 diabetes who applied to the Internal Medicine Polyclinic of Bayburt State Hospital in the city center of Bayburt will the diagnosis of Type 2 diabetes will form the sample of the study. The sample will consist of two groups, the geriatric massage group and the control group. Data will be collected with the "Elderly Information Form", "Standardized Mini-Mental Test", "Diabetes Symptoms Checklist Scale", "Blood Parameters Monitoring Form". "Geriatric Massage" will be applied as an intervention. The geriatric massage group will receive 20 minutes (10 minutes on each foot) foot massage and 10 minutes back massage, two days a week for eight weeks. The control group will receive the institution's standard of care. Frequency, number, mean, Student's t test and/or Mann-Whitney U test, ANOVA and/or Kruskal-Wallis test, Chi-square test and/or Correlation and Regression Analysis will be used in the analysis of the data. As a result of this study, it is anticipated that the effects of geriatric massage on diabetes symptoms and blood parameters in the elderly with Type 2 diabetes will be determined and these effects will be included in evidence-based guidelines.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The research was planned as a pre test-post test randomized controlled single-center study.
| Arm | Type | Receives |
|---|---|---|
| Geriatric Massage Group | Experimental | Other: Feet and Back MassageThe fragility of the elderly, the sensitivity of skin, muscle and bone tissue necessitate modification of massage techniques according to the individual characteristics of the elderly. Geriatric massage is a form of massage applied according to the characteristics of the elderly individual and can be applied to all body parts according to the needs of the elderly. However, since diabetic neuropathy, which is a long-term complication that is common in individuals with Type 2 diabetes and can affect all body parts, shows more symptoms in the feet, foot massage as a geriatric massage may be effective in reducing diabetes symptoms and improving blood parameters. Because of its more systemic effects, back massage was preferred. |
| Control Group | No intervention | –No attempt will be made by the researcher on the elderly with Type 2 diabetes in the control group. The elderly in this group will benefit from the standard care practices offered by the institution. |
Who may qualify
- Ages
- 65 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Age 65-84
- No visual or hearing impairment
- Ability to communicate verbally
- Applying to Bayburt State Hospital Internal Medicine Polyclinic
- Having a diagnosis of Type 2 diabetes for at least six months
Key exclusion criteria (7 listed)
- Having vascular disease (thrombus, phlebitis, arterial embolism, severe venous ulceration)
- Having heart failure, pacemaker and neurological disease
- Body temperature being higher than 37.5°C for more than two days, suspected or diagnosed with inflammation
- Having acute pain
- Cancer and undiagnosed malignancies, receiving chemotherapy and radiotherapy
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 |
|---|---|---|
| Feet and Back MassageFoot massage: Feet are the most neglected organs of people and therefore cause many complaints. Foot massage is a massage applied to the back of the foot, toes, soles of the feet, the muscles between the thumb and little fingers, and the heel, where the muscles between the metatarsal bones are located. Back massage: Back massage is a non-invasive nursing intervention that can be easily applied by nurses. In back massage application; A 10-minute back massage program applied by Çınar and Eşer (2012) will be applied. | Other | Geriatric Massage Group |
Primary outcome
Elderly Information Form
Time frame: First day
This form, which was created by the researchers by scanning the literature, consists of two parts. In the first part, seven questions to determine the introductory characteristics of the elderly (age, gender, marital status, place of residence, education level, occupation, smoking and alcohol use); In the second part, there are a total of 13 questions, six of which are aimed at determining the diabetes characteristics of the elderly (duration of diabetes, type of treatment, regular application of treatment, presence of other chronic diseases, attention to diet, regular exercise).
Standardized Mini Mental Test (SMMT)
Time frame: will be applied on the first day. If the Standardized Mini Mental Test result is not 25 points or more, the patient will be excluded.]
This test consists of "orientation, recording, attention, calculation, reminder, language tests and configuration" sections. Test; It is a test that can be administered by physicians, nurses and psychologists in a short time (10 minutes), outpatient conditions or at the bedside. The test was developed for the purpose of short-term cognitive assessment in the elderly, especially in the examination of delirium or dementia.Each question in the test is worth "1" point. The lowest score that can be obtained from the scale is "0" and the highest score is "30". According to the points received; 0-12 points at "severe" level, 13-22 points at "moderate" level and 23-24 points at "mild" level as "cognitive impairment"; A score between 25 and 30 is considered as "no cognitive impairment".
Diabetes Symptoms Checklist Scale
Time frame: First week
This scale was developed by Grootenhuis et al. The scale assesses the physical and psychological symptoms and perceived burden of Type 2 diabetes and its complications. The scale consisting of thirty-four items; It includes six sub-dimensions: "hyperglycemia, hypoglycemia, psychology, cardiology, ophthalmatology and neurology". Each item in the scale is numbered from 0 to 5 point. If the individual with diabetes says that he/she experiences the related symptom, that is, if he/she answers "yes", he/she chooses the level of discomfort perceived by the individual on a scale from 1 to 5 point. If the person with diabetes says that there are no symptoms, the item is evaluated as "0 point". The total score and all sub-dimension scores in the scale range from 0 to 5 point, with higher scores indicating greater symptom burden.
Blood Parameters Follow-up Form
Time frame: First week
This form was created by the researcher by scanning the literature to record and monitor the blood parameters of the elderly with diabetes. in form; There are seven values including glycosylated hemoglobin (HbA1C/%), fasting plasma glucose (APG/mg/dl), triglyceride (TG/mg/dl), high-density lipoprotein (HDL/mg/dl), low-density lipoprotein (LDL/mg/dl), creatinine mg/dl and urea mg/dl values of the elderly. These seven values are routinely requested from all patients who come to Bayburt State Hospital Internal Medicine Outpatient Clinic with the diagnosis of Type 2 diabetes and the results are recorded in the computer environment. Blood parameter results will be taken from the computer environment and recorded by the researcher.
4 secondary outcomes
Diabetes Symptoms Checklist Scale
Time frame: Forth week
Diabetes Symptoms Checklist Scale
Time frame: Eighth week
Diabetes Symptoms Checklist Scale
Time frame: Twelfth week
Blood Parameters Follow-up Form
Time frame: Twelfth week
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 9 Jan 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feet and Back Massage in people with Nursing Caries, run by Bayburt 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 7 inclusion and 7 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 9 Jan 2024. 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?
Elderly Information Form (time frame: First day). 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 9 Jan 2024.