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

NCT04436666 | Completed

• 1 other identifier: seher cevik
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Injection Site Irritation; Fear of Pain

Keywords

Insulin injection; fear of injection; Ice application; Virtual reality

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  1 month

Study Arms (3)

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.

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.

Device: motivational video production through virtual reality glasses

control

NO INTERVENTION

No Intervention

Interventions

motivational video production through virtual reality glasses 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.

Virtual Reality

Ice Application 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.

Ice Application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

seher ÇEVİK

Malatya, 44280, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 29799614 BACKGROUND

MeSH Terms

Conditions

Iatrophobia

Study Officials

• seher ÇEVİK

  Inonu University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: June 18, 2020
• Study Start: July 15, 2020
• Primary Completion: December 30, 2020
• Study Completion: June 30, 2021
• Last Updated: December 6, 2022

Record last verified: 2022-12

Locations

TU (1)