Injection Site IrritationNCT04436666
Virtual Reality, Ice Application and Self-injection and Self-test Fair, Pain and State Anxiety
A study testing motivational video production through virtual reality glasses and Ice Application in people with Injection Site Irritation and Fear of Pain, run by Inonu University at 1 site in Turkey (Türkiye).
Trial summary
AİM:The aim of this study is to control the fears and anxieties of Type 2 diabetics in insulin injection and blood glucose measurement with motivational videos and Ice applications to be applied with virtual reality glasses. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Injection Site Irritation, Fear of Pain
- What is being tested?
- motivational video production through virtual reality glasses and Ice Application
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jul 2020to 30 Jun 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being literate,
- Injecting insulin at least twice a day,
- Following blood sugar at least twice a day,
Who cannot join
- Having any psychiatric diagnosis,
- communication barriers
- The patient has any diagnosis, such as epilepsy, that will trigger seizures.
- Any diagnosis, such as vertigo, that causes dizziness in the patient.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality and Ice Application on Fear of Self-injection and Self-test, Pain and State Anxiety Levels in Patients With Type 2 Diabetes
AİM:The aim of this study is to control the fears and anxieties of Type 2 diabetics in insulin injection and blood glucose measurement with motivational videos and Ice applications to be applied with virtual reality glasses.
Material and Methods: The research is designed as a semi-experimental model with pretest-posttest control groups. The research will be carried out in the endocrine services located in Turgut Özal Medical Center in Malatya province. The universe of the research will be 2113 Type 2 diabetes patients who are being treated in the hospital specified on the specified dates, who are injecting insulin and following blood sugar. According to the analysis of the power, the sample of the research is composed of an experiment effect of 0.5% with bilateral significance level, 95% confidence interval determined with 5% error level, the experiment group to be applied with 80% Reality with 80% representation power, and the control group with 80 ice application. will create a total of 240 Type 2 diabetes patients.In the collection of the data, the Participant Presentation Form developed by the researcher, Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ, State Anxiety Scale and VAS will be used.
Read the detailed description
VR is a relatively new human-computer interaction tool in which a person becomes an active participant in a virtual world. Sensory cues of VR, especially the precise control of auditory, tactile and olfactory systems, enhances the reality of the virtual environment. As a result, users feel that they can look around and enter the simulated environment. The virtual environment provides sensory information such as visual, auditory, movement, virtual or artificial, and makes the individual feel similar to real life.
Ice application has been used as a topical pain reliever for centuries. It works through a variety of mechanisms, such as slowing the transmission of peripheral nerve fibers, promoting sensory competition, and reducing the release of inflammatory and nociceptive mediators. Ice application is cheap, easily accessible and reaches its purpose relatively quickly to skin anesthesia. Apart from these effects, it also reduces pain by activating the Door-Control mechanism, stimulating the touch receptors and increasing the release of endogenous opioids.
- Conditions
- Injection Site Irritation, Fear of Pain
- Being tested
- motivational video production through virtual reality glasses, Ice Application
- Keywords
- Insulin injection, fear of injection, Ice application, Virtual reality
- Medical subject headings
- Iatrophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motivational video production through virtual reality glassesDevice
Music-funded, park, nature and seaside walks, submarine, museum, with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel display resolution, China) for 10 minutes to diabetic patients before blood glucose measurement and insulin injection The videos that the patient wants to watch will be watched from videos such as his trip Studies have indicated that these videos are relaxing environments, and motion videos should not be watched to reduce nausea and vomiting.
Ice ApplicationOther
Before the blood glucose measurement and insulin injection, patients with diabetes will be given ice for 5 minutes. It is planned to apply ice cubes in liquid-proof ice bags.
| Study group | Role | What they receive |
|---|---|---|
| Ice Application | Experimental | Music-funded, park, nature and seaside walks, submarine, museum, with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel display resolution, China) for 10 minutes to diabetic patients before blood glucose measurement and insulin injection The videos that the patient wants to watch will be watched from videos such as his trip Studies have indicated that these videos are relaxing environments, and motion videos should not be watched to reduce nausea and vomiting. Receives: Other: Ice Application |
| Virtual Reality | Experimental | Before the blood glucose measurement and insulin injection, patients with diabetes will be given ice for 5 minutes. It is planned to apply ice cubes in liquid-proof ice bags. Receives: Device: motivational video production through virtual reality glasses |
| control | No intervention | No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Injection fear reduction
(Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ) D-FISQ was developed by Snoek et al. (1997) to measure the fear of self-injection and testing in individuals with diabetes who need insulin. D-FISQ with 15 expressions consists of two sub-dimensions, fear of self-injecting-FSI, 6 expressions, and fear of self-testing (FST, 9 expressions). Each statement has a 4-point Likert-type rating ranging from 1 to 4 (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). The evaluation of the inquiry form can be done by taking the average or raw score for the two sub-dimensions and the whole form. As the scores obtained from the scale increase, fear levels increase. Internal consistency coefficient of the scale is 0.96.
Measured: 1 month
anxiety reducation
State Anxiety Scale The scale, which was developed by Spielberger et al in 1970, was adapted to Turkish by Öner and LeCompte (1974). The emotions or behaviors expressed in the scale items are answered by marking one of the options such as (1) none, (2) a little, (3) a lot, and (4) completely. The scale containing twenty expressions contains 10 inverse (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) expressions. While the reverse expressions expressing positive emotions are scored, those in one weight degree are converted into four, and those in four weight degrees into one. In the scoring, the total weighted score of the inverse statements is subtracted from the total weighted score and 50, an unchanged value, is added to this number. The total score value obtained from the scale can range from 20 to 80 points. A high score indicates that the level of anxiety is high. The total score value is evaluated as 20-39 mild anxiety, 40-59 moderate anxiety, and 60-79 severe anxiety.
Measured: 1 month
pain relief
(Visual Analogue Scale -VAS) This scale, which is used to measure subjectively perceived pain, was developed by Price et al. (1983), and has been used in many studies to evaluate the intensity of pain, it has been found to be reliable and valid. It is a 10 cm scale with "painlessness" on one end and "severe pain" on the other. Individuals participating in the study are asked to mark the level of pain severity they feel at the moment, explaining that the number "0" on the scale means that I do not feel any pain and the pain intensity increases as the numbers grow and the number "10" means the most severe pain.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start15 Jul 2020
- Primary completion30 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Injection Site IrritationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, seher ÇEVİK, Inonu University
- Investigators
- seher ÇEVİK, Principal investigator, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436666
- Sponsor's protocol ID
- seher cevik
- Status last verified
- Dec 2022
- First submitted
- 15 Jun 2020
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cevik S, Yagmur Y. Impact of intolerance of uncertainty on psychological well-being in pregnant women with or without miscarriage risk. Perspect Psychiatr Care. 2018 Jul;54(3):436-440. doi: 10.1111/ppc.12297. Epub 2018 May 25.
PubMed 29799614
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality and Ice Application on Fear of Self-injection and Self-test, Pain and State Anxiety Levels in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04436666
- Acronym / sponsor ID
- seher cevik
- Conditions
- Injection Site Irritation, Fear of Pain
- Keywords
- Insulin injection, fear of injection, Ice application, Virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 18 Jun 2020 (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.
AİM:The aim of this study is to control the fears and anxieties of Type 2 diabetics in insulin injection and blood glucose measurement with motivational videos and Ice applications to be applied with virtual reality glasses.
Material and Methods: The research is designed as a semi-experimental model with pretest-posttest control groups. The research will be carried out in the endocrine services located in Turgut Özal Medical Center in Malatya province. The universe of the research will be 2113 Type 2 diabetes patients who are being treated in the hospital specified on the specified dates, who are injecting insulin and following blood sugar. According to the analysis of the power, the sample of the research is composed of an experiment effect of 0.5% with bilateral significance level, 95% confidence interval determined with 5% error level, the experiment group to be applied with 80% Reality with 80% representation power, and the control group with 80 ice application. will create a total of 240 Type 2 diabetes patients.In the collection of the data, the Participant Presentation Form developed by the researcher, Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ, State Anxiety Scale and VAS will be used.
Detailed description
VR is a relatively new human-computer interaction tool in which a person becomes an active participant in a virtual world. Sensory cues of VR, especially the precise control of auditory, tactile and olfactory systems, enhances the reality of the virtual environment. As a result, users feel that they can look around and enter the simulated environment. The virtual environment provides sensory information such as visual, auditory, movement, virtual or artificial, and makes the individual feel similar to real life.
Ice application has been used as a topical pain reliever for centuries. It works through a variety of mechanisms, such as slowing the transmission of peripheral nerve fibers, promoting sensory competition, and reducing the release of inflammatory and nociceptive mediators. Ice application is cheap, easily accessible and reaches its purpose relatively quickly to skin anesthesia. Apart from these effects, it also reduces pain by activating the Door-Control mechanism, stimulating the touch receptors and increasing the release of endogenous opioids.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ice Application | Experimental | Other: Ice ApplicationMusic-funded, park, nature and seaside walks, submarine, museum, with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel display resolution, China) for 10 minutes to diabetic patients before blood glucose measurement and insulin injection The videos that the patient wants to watch will be watched from videos such as his trip Studies have indicated that these videos are relaxing environments, and motion videos should not be watched to reduce nausea and vomiting. |
| Virtual Reality | Experimental | Device: motivational video production through virtual reality glassesBefore the blood glucose measurement and insulin injection, patients with diabetes will be given ice for 5 minutes. It is planned to apply ice cubes in liquid-proof ice bags. |
| control | No intervention | –No Intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being literate,
- Injecting insulin at least twice a day,
- Following blood sugar at least twice a day,
Key exclusion criteria (4 listed)
- Having any psychiatric diagnosis,
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 |
|---|---|---|
| motivational video production through virtual reality glassesMusic-funded, park, nature and seaside walks, submarine, museum, with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel display resolution, China) for 10 minutes to diabetic patients before blood glucose measurement and insulin injection The videos that the patient wants to watch will be watched from videos such as his trip Studies have indicated that these videos are relaxing environments, and motion videos should not be watched to reduce nausea and vomiting. | Device | Virtual Reality |
| Ice ApplicationBefore the blood glucose measurement and insulin injection, patients with diabetes will be given ice for 5 minutes. It is planned to apply ice cubes in liquid-proof ice bags. | Other | Ice Application |
Primary outcome
Injection fear reduction
Time frame: 1 month
(Diabetes Fear of Self Injecting and Self-testing Questionnaire-D-FISQ) D-FISQ was developed by Snoek et al. (1997) to measure the fear of self-injection and testing in individuals with diabetes who need insulin. D-FISQ with 15 expressions consists of two sub-dimensions, fear of self-injecting-FSI, 6 expressions, and fear of self-testing (FST, 9 expressions). Each statement has a 4-point Likert-type rating ranging from 1 to 4 (1 = almost never, 2 = sometimes, 3 = often, 4 = almost always). The evaluation of the inquiry form can be done by taking the average or raw score for the two sub-dimensions and the whole form. As the scores obtained from the scale increase, fear levels increase. Internal consistency coefficient of the scale is 0.96.
anxiety reducation
Time frame: 1 month
State Anxiety Scale The scale, which was developed by Spielberger et al in 1970, was adapted to Turkish by Öner and LeCompte (1974). The emotions or behaviors expressed in the scale items are answered by marking one of the options such as (1) none, (2) a little, (3) a lot, and (4) completely. The scale containing twenty expressions contains 10 inverse (1, 2, 5, 8, 10, 11, 15, 16, 19, 20) expressions. While the reverse expressions expressing positive emotions are scored, those in one weight degree are converted into four, and those in four weight degrees into one. In the scoring, the total weighted score of the inverse statements is subtracted from the total weighted score and 50, an unchanged value, is added to this number. The total score value obtained from the scale can range from 20 to 80 points. A high score indicates that the level of anxiety is high. The total score value is evaluated as 20-39 mild anxiety, 40-59 moderate anxiety, and 60-79 severe anxiety.
pain relief
Time frame: 1 month
(Visual Analogue Scale -VAS) This scale, which is used to measure subjectively perceived pain, was developed by Price et al. (1983), and has been used in many studies to evaluate the intensity of pain, it has been found to be reliable and valid. It is a 10 cm scale with "painlessness" on one end and "severe pain" on the other. Individuals participating in the study are asked to mark the level of pain severity they feel at the moment, explaining that the number "0" on the scale means that I do not feel any pain and the pain intensity increases as the numbers grow and the number "10" means the most severe pain.
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 6 Dec 2022.
- Background: PubMed 29799614Cevik S, Yagmur Y. Impact of intolerance of uncertainty on psychological well-being in pregnant women with or without miscarriage risk. Perspect Psychiatr Care. 2018 Jul;54(3):436-440. doi: 10.1111/ppc.12297. Epub 2018 May 25.
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.
seher ÇEVİK principal investigator
Inonu 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 motivational video production through virtual reality glasses and Ice Application in people with Injection Site Irritation and Fear of Pain, run by Inonu 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 3 inclusion and 4 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 6 Dec 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?
Injection fear reduction (time frame: 1 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04436666, which also lists 1 linked publication.
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 6 Dec 2022; AzTrials last refreshed its copy on 27 Oct 2026.