The Effects Of Virtual Reality and Stress Ball Application on Pain, Anxiety Levels and Injection Satisfaction in During Insulin Injection in Geriatric Patients With Type 2 Diabetes

NCT ID: NCT07348809

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-01
• Study Completion Date: 2026-01-15

Brief Summary

The effects of virtual reality and stress ball applied during insulin injection on pain, anxiety levels and injection satisfaction in geriatric patients with type 2 diabetes.

Insulin injection in geriatric patients with type 2 diabetes causes pain and anxiety, making the treatment process difficult. The aim of the study is to determine the effect of virtual reality and stress ball application on pain, anxiety levels and injection satisfaction during insulin injection in geriatric patients with Type 2 diabetes. Randomization will be achieved by randomly and equally distributing patients who meet the sample selection criteria at Tarsus State Hospital to 3 groups (1st experimental group, 2nd experimental group and 3rd group control group) through a computer program. Considering that there may be case losses, a total of 90 patients (1st Experimental Group [virtual reality applied]: 30 patients, 2nd Experimental Group [stress ball applied]: 30 patients, control group: 30 patients) will be included in the sample group. In collecting data; A data collection form consisting of "Personal Information Form", "Visual Analog Scale (VAS)", State Anxiety Inventory (DCI), "Visual Patient Satisfaction Scale" forms will be used.

Detailed Description

Diabetes is a disease that occurs due to insufficient production of insulin hormone, deficiency or inability to use the insulin hormone produced. Diabetes is an important disease whose incidence is increasing every year, negatively affecting quality of life and causing morbidity and mortality. According to the 2021 data of the National Diabetes Federation, approximately 10.5% of the adult population worldwide has diabetes and almost half of these patients are not aware of their disease. Type 2 diabetes is the most common form of diabetes and accounts for approximately 90% of the entire population. Many factors such as unfavorable living conditions, low socioeconomic level, obesity and advanced age cause type 2 diabetes. Type 2 diabetes, which is the most common chronic disease seen in geriatric patients and also a serious life-threatening disease, is becoming increasingly common in the elderly population with the prolongation of life expectancy. Aging is a process that leads to many anatomical and physiological changes in individuals and brings with it the risks of various pathological conditions. With this process, there is an increase in the incidence of chronic diseases such as type 2 diabetes, which causes psychological and physiologic decline requiring long-term treatments, close follow-up and serious care. In addition to factors such as lifestyle changes and diabetes awareness, insulin therapy also plays a very important role in the management of diabetes. Insulin treatment is the primary option in case of oral hypoglycemic drug failure or development of diabetes-induced vascular complications. In order to eliminate side effects and have glycemic control in insulin treatment, patients should be knowledgeable about their diseases and insulin treatments, and in addition, they should be competent and have a positive perspective about insulin injection administration. The anxiety experienced by patients during insulin injection may negatively affect emotional well-being and glycemic control. According to the results of a study, it was reported that approximately 48.4% of patients with diabetes experienced noncompliance with treatment because of the pain they would experience during insulin injection and the thought of not being able to endure this pain. In the light of today's technological developments, various methods are applied to patients to divert attention during treatment. Virtual reality and stress ball applications are some of these applications. Thanks to the distraction technique, attention is diverted away from the pain and the severity in the perception of pain is reduced. Nurses play an important role in the management, implementation and rehabilitation of the treatment process of patients. Due to many procedures such as various injection applications, invasive interventions and care applications, nurses are in close interaction with patients and take important responsibilities in the management of many conditions such as pain, fear and anxiety that occur in the patient during this interaction. In some studies in the literature, it is known that virtual reality goggles and stress ball applications are used during dressing changes in patients with burns, painful invasive interventions, chemotherapy applications, bronchoscopy, cystoscopy and hemodialysis. However, there is no study in the literature examining the effect of virtual reality and stress ball applications on pain, anxiety level and injection satisfaction during insulin injection in geriatric patients with type 2 diabetes. This study is thought to contribute to the literature by filling this gap.

Conditions

Diabete Type 2; Virtual Reality; Stress Ball; Procedural Anxiety; Pain Management

Study Design

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

Study Groups

control

First, the State-Trait Anxiety Inventory (STAI) was administered as a pre-test before both blood sugar measurement and insulin injection. These procedures were then performed. After their completion, the VAS and STAI were administered again as a post-test

Group Type: NO_INTERVENTION

No interventions assigned to this group

virtual reality

First, the State-Trait Anxiety Inventory (STAI) was administered as a pre-test before blood sugar measurement. Then, five minutes before their blood sugar was taken, patients started watching motivational videos via virtual reality glasses and continued watching throughout the measurement. Before the videos began, patients were given instructions on how to use the headset and what to expect. After the blood sugar measurement, the STAI, VAS and VPSS were administered. Next, the STAI was given as a pre-test before the insulin injection. Five minutes before the insulin injection, motivational videos were again shown through the virtual reality glasses and continued during the injection. Following this procedure, the STAI, VAS, and VPSS were administered once more as a final test.

Group Type: EXPERIMENTAL

virtual reality

Intervention Type: DEVICE

The patients in the virtual reality group watched motivational videos of their choice from YouTube (e.g., nature scenes, seaside walks, underwater views), accompanied by background music. These videos were displayed using Glasses (featuring a 5.7-inch, 1440x2560 pixel screen resolution display from China) and shown in VR mode via a Samsung A51 smartphone before both blood sugar testing and insulin injection (Figure 1). While previous studies typically showed virtual reality videos for 5-10 minutes (kaynak), in this study, patients viewed motivational videos for 5 minutes to help them more easily immerse themselves in the virtual world.

stress ball

On the second day, the stress ball group's procedures were as follows:

First, we administered the State-Trait Anxiety Inventory (STAI) as a pre-test before measuring blood sugar levels. Patients were then instructed to focus on and continuously squeeze and release the stress ball until their blood sugar measurement was complete. Afterward, blood sugar measurements were taken. Following the blood sugar measurement, the VAS, STAI and VPSS were administered. Next, the STAI was given as a pre-test before the insulin injection. Patients continued to squeeze and release the stress ball, focusing their attention on it, until the insulin injection was finished. After the injection, the VAS, STAI, and VPSS were administered again as a post-test.

Group Type: EXPERIMENTAL

stress ball

Intervention Type: DEVICE

The stress balls used in the study were 3 cm in diameter, round, and constructed from medium-hardness, high-quality silicone. These were sourced and distributed to patients by the researchers

Interventions

stress ball

The stress balls used in the study were 3 cm in diameter, round, and constructed from medium-hardness, high-quality silicone. These were sourced and distributed to patients by the researchers

Intervention Type: DEVICE

virtual reality

The patients in the virtual reality group watched motivational videos of their choice from YouTube (e.g., nature scenes, seaside walks, underwater views), accompanied by background music. These videos were displayed using Glasses (featuring a 5.7-inch, 1440x2560 pixel screen resolution display from China) and shown in VR mode via a Samsung A51 smartphone before both blood sugar testing and insulin injection (Figure 1). While previous studies typically showed virtual reality videos for 5-10 minutes (kaynak), in this study, patients viewed motivational videos for 5 minutes to help them more easily immerse themselves in the virtual world.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• age 65 or older,
• at least two daily insulin injections and blood sugar monitoring,
• a minimum of 6 months of insulin treatment
• no hand or arm problems preventing stress ball use,
• be able to communicate in Turkish,
• have no orders that would hinder communication (e.g., psychological or related to hearing/understanding)
• volunteer to participate in the study.

Exclusion Criteria

• if they have: epilepsy, vertigo, anxiety, active nausea, vomiting, or headaches
• regularly use painkillers
• have chronic pain disorders
• have previously experienced virtual reality
• have any problems in the arm's injection area

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tarsus University

OTHER

Sponsor Role: lead

Responsible Party

ezgi mutluay yayla

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tarsu University

Mersin, Mersin, Health Sciences Faculty ,, Turkey (Türkiye)

Tarsus University

Mersin, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

SBF.23.004

Identifier Type: -

Identifier Source: org_study_id