Diabetes MellitusNCT05566912
Practices Made by Patients to Avoid Insulin Injection Pain
An observational study of Diabetes Mellitus, run by Selcuk University at 1 site in Turkey (Türkiye).
Trial summary
Abstract Objective: This study was conducted to determine the knowledge levels of DM patients about the disease and insulin use, and their practices to avoid insulin injection pain. Methods: Data were collected from 399 patients who administered insulin injections in the study. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- filling out a survey
- How many people
- 399 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 Apr 2022
- How long will I take part?
- 7 Months
- Phase
- Observational
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with diabetes between the ages of 18-65
Who may be able to join
- Patients between the ages of 18-65, diagnosed with diabetes mellitus at least 1 year ago, injecting themselves with insulin.
Who cannot join
- Having no communication problems, and having no mental illness were included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AVOIDING PAIN CAUSED BY INSULIN INJECTION Patients Using Insulin With Diabetes Seek For Painless Injection
Abstract Objective: This study was conducted to determine the knowledge levels of DM patients about the disease and insulin use, and their practices to avoid insulin injection pain.
Methods: Data were collected from 399 patients who administered insulin injections in the study. Patient identification form, disease and treatment compliance form, Morisky-8 Treatment Adherence Scale (MMAS-8), and Visual Analog Scale were used for data collection. The data were collected by the same researcher by face-to-face interview technique.
Read the detailed description
The face-to-face interview technique was applied to all patients who met the inclusion criteria and accepted to participate in the study, in the waiting area of the internal medicine outpatient clinic. Data were collected by the same researcher. Questionnaire forms were filled in the form of questions and answers in 10-15 minutes.
- Conditions
- Diabetes Mellitus
- Being tested
- filling out a survey
- Keywords
- Insuline injection pain, lipohypertrophy, nursing care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
filling out a surveyOther
This research is a descriptive study
What is being measured
The primary outcome is the main question the study is designed to answer.
Completing the surveys
Completion of all questionnaires by patients
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start15 Oct 2021
- Primary completion15 Jan 2022
- Study completion15 Apr 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 399 participants (actual)
- Target duration
- 7 Months
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Halil Ibrahim Tuna PhD, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05566912
- Sponsor's protocol ID
- Insulin Injection Pain
- Status last verified
- Oct 2022
- First submitted
- 27 Sep 2022
- Last updated
- 5 Oct 2022
- 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 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVOIDING PAIN CAUSED BY INSULIN INJECTION Patients Using Insulin With Diabetes Seek For Painless Injection
- ClinicalTrials.gov ID
- NCT05566912
- Acronym / sponsor ID
- Insulin Injection Pain
- Conditions
- Diabetes Mellitus
- Keywords
- Insuline injection pain, lipohypertrophy, nursing care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 5 Oct 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.
Abstract Objective: This study was conducted to determine the knowledge levels of DM patients about the disease and insulin use, and their practices to avoid insulin injection pain.
Methods: Data were collected from 399 patients who administered insulin injections in the study. Patient identification form, disease and treatment compliance form, Morisky-8 Treatment Adherence Scale (MMAS-8), and Visual Analog Scale were used for data collection. The data were collected by the same researcher by face-to-face interview technique.
Detailed description
The face-to-face interview technique was applied to all patients who met the inclusion criteria and accepted to participate in the study, in the waiting area of the internal medicine outpatient clinic. Data were collected by the same researcher. Questionnaire forms were filled in the form of questions and answers in 10-15 minutes.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 7 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with diabetes between the ages of 18-65
Key inclusion criteria (1 listed)
- Patients between the ages of 18-65, diagnosed with diabetes mellitus at least 1 year ago, injecting themselves with insulin.
Key exclusion criteria (1 listed)
- Having no communication problems, and having no mental illness were included in the study.
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 |
|---|---|---|
| filling out a surveyThis research is a descriptive study | Other | – |
Primary outcome
Completing the surveys
Time frame: 7 months
Completion of all questionnaires by patients
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 5 Oct 2022.
- 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?
An observational study of Diabetes Mellitus, run by Selcuk 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 1 inclusion and 1 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 5 Oct 2022. 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?
Completing the surveys (time frame: 7 months). 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 5 Oct 2022.