- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07348809
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 (TYPE 2 DİABETE)
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mersin, Turkey (Türkiye)
- Tarsus University
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Mersin, Health Sciences Faculty ,
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Mersin, Mersin, Health Sciences Faculty ,, Turkey (Türkiye), 33400
- Tarsu University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: 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
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Experimental: 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.
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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.
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Experimental: 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. |
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Descriptive Information Form were used to collect the data.
Time Frame: The first day;15 minutes before blood sugar measurements and insulin injections are administered
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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.
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The first day;15 minutes before blood sugar measurements and insulin injections are administered
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The Visual Patient Satisfaction Scale (VPSS)
Time Frame: The second day; intervention groups were administered after the blood sugar and insulin procedures and after an average of 3-5 minutes.
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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."
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The second day; intervention groups were administered after the blood sugar and insulin procedures and after an average of 3-5 minutes.
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Visual analogue scale were used to collect the data.
Time Frame: The first day ; during the blood sugar and insulin procedures and baseline, after an average of 1-2 minutes
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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.
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The first day ; during the blood sugar and insulin procedures and baseline, after an average of 1-2 minutes
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State-Trait Anxiety Inventory (STAI)
Time Frame: The first day ; before the blood sugar and insulin procedures and after procedure an average of 1-2 minutes.,
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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.
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The first day ; before the blood sugar and insulin procedures and after procedure an average of 1-2 minutes.,
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual analogue scale were used to collect the data.
Time Frame: The second day; during the blood sugar and insulin procedures and , after an average of 1-2 minutes
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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.
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The second day; during the blood sugar and insulin procedures and , after an average of 1-2 minutes
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State-Trait Anxiety Inventory (STAI)
Time Frame: The second day; before the blood sugar and insulin procedures and after an average of 1-2 minutes.
|
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.
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The second day; before the blood sugar and insulin procedures and after an average of 1-2 minutes.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Endocrine System Diseases
- Nervous System Diseases
- Mental Disorders
- Metabolic Diseases
- Neurobehavioral Manifestations
- Glucose Metabolism Disorders
- Diabetes Mellitus
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Nutritional and Metabolic Diseases
- Signs and Symptoms
- Pain
- Anxiety Disorders
- Diabetes Mellitus, Type 2
- Agnosia
Other Study ID Numbers
- SBF.23.004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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