NCT07348809

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2024

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 26, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 16, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2026

Completed
Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

November 26, 2025

Last Update Submit

February 24, 2026

Conditions

Keywords

anxietyneedlepainstress ballType 2 diabetesvirtual reality

Outcome Measures

Primary Outcomes (4)

  • Descriptive Information Form were used to collect the data.

    Descriptive Information Form The descriptive information form was created by evaluating the studies conducted with older adults with type 2 diabetes. A total of 13 questions were asked about the patient's year of birth, education level, marital status, employment status, year of diabetes diagnosis, duration of insulin use, etc. in the descriptive information form.The first day involved no interventional procedures for any group (virtual reality, stress ball, or control). The data collection sequence was as follows: Participants first completed the Descriptive Information Form.

    The first day;15 minutes before blood sugar measurements and insulin injections are administered

  • The Visual Patient Satisfaction Scale (VPSS)

    This scale, which combines features of the well-known Visual Analogue Scale (VAS), is a 100 mm horizontal line without numbers. It is anchored at one end by 'Not at all satisfied' and at the other by 'Very satisfied.' Patients will use this scale to indicate their level of satisfaction with the virtual reality and stress ball applications by marking the point on the line that best corresponds to their experience. The scale was evaluated and recorded by a nurse who was independent of the study."

    The second day; intervention groups were administered after the blood sugar and insulin procedures and after an average of 3-5 minutes.

  • Visual analogue scale were used to collect the data.

    Description: The Turkish validity and reliability of the pain severity scale, originally developed by Price et al. (1994), was established by Eti Aslan (2004) for assessing postoperative pain. This scale, graded from 0 to 10, uses 0 to represent 'I have no pain' and 10 to represent 'I have bearable pain.' Written permission to use the scale was obtained via email from Eti Aslan. A total of Visual Analog Scale (VAS) values were recorded by a study-independent nurse of the study.

    The first day ; during the blood sugar and insulin procedures and baseline, after an average of 1-2 minutes

  • State-Trait Anxiety Inventory (STAI)

    Description: The State-Trait Anxiety Inventory developed by Spielberger et al. to measure state and trait anxiety levels, was adapted into Turkish by Öner and Le Compte. The STAI-I form was used to assess participants' transitory emotional states and anxiety levels. This 20-item scale utilizes a 4-point Likert scale, with items scored from 1 ('not at all') to 4 ('very much'). The total score, ranging from 20 to 80, indicates anxiety levels, with higher scores signifying greater anxiety. In a Turkish validity and reliability study, the internal consistency coefficients ranged from 0.94 to 0.96. For the current study, the STAI-I's Cronbach's alpha coefficient was determined to be 0.95. The scale was evaluated and recorded by a nurse independent of the study.

    The first day ; before the blood sugar and insulin procedures and after procedure an average of 1-2 minutes.,

Secondary Outcomes (2)

  • Visual analogue scale were used to collect the data.

    The second day; during the blood sugar and insulin procedures and , after an average of 1-2 minutes

  • State-Trait Anxiety Inventory (STAI)

    The second day; before the blood sugar and insulin procedures and after an average of 1-2 minutes.

Study Arms (3)

control

NO INTERVENTION

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

virtual reality

EXPERIMENTAL

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.

Device: virtual reality

stress ball

EXPERIMENTAL

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.

Device: stress ball

Interventions

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.

virtual reality

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

stress ball

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tarsu University

Mersin, Mersin, Health Sciences Faculty ,, 33400, Turkey (Türkiye)

Location

Tarsus University

Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2AgnosiaAnxiety DisordersPain

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study is a randomized controlled trial with control and intervention groups, pre-test and post-test.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 26, 2025

First Posted

January 16, 2026

Study Start

November 1, 2024

Primary Completion

January 15, 2026

Study Completion

February 15, 2026

Last Updated

February 25, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations