Virtual Reality, Ice Application and Self-injection and Self-test Fair, Pain and State Anxiety

NCT ID: NCT04436666

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2021-06-30

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.

Conditions

Injection Site Irritation; Fear of Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Ice Application

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.

Group Type: EXPERIMENTAL

Ice Application

Intervention Type: OTHER

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.

Virtual Reality

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.

Group Type: EXPERIMENTAL

motivational video production through virtual reality glasses

Intervention Type: DEVICE

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.

control

No Intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

motivational video production through virtual reality glasses

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.

Intervention Type: DEVICE

Ice Application

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

seher ÇEVİK

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

seher ÇEVİK

Role: PRINCIPAL_INVESTIGATOR

Inonu University

Locations

seher ÇEVİK

Malatya, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 29799614 (View on PubMed)

Other Identifiers

seher cevik

Identifier Type: -

Identifier Source: org_study_id