Clinical trial NCT04436666: Virtual Reality, Ice Application and Self-injection and Self-test Fair, Pain and State Anxiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injection Site Irritation
Fear of Pain
Keywords: Insulin injection
fear of injection
Ice application
Virtual reality
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Being literate,
* Injecting insulin at least twice a day,
* Following blood sugar at least twice a day,

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Injection fear reduction
timeFrame: 1 month
measure: anxiety reducation
timeFrame: 1 month
measure: pain relief
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: seher ÇEVİK
Study officials:
affiliation: Inonu University
name: seher ÇEVİK
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.