Effects of Virtual Reality Glasses and Stress Ball Application on Pain, Anxiety and Patient Satisfaction in Intramuscular Injection Application
Examining the Effects of Virtual Reality Glasses and Stress Ball Application on Pain, Anxiety and Patient Satisfaction in Intramuscular Injection Application: Randomized Controlled Study
1 other identifier
interventional
120
1 country
1
Brief Summary
Purpose: This study was planned to examine the effects of virtual reality glasses and stress ball application on pain, anxiety and patient satisfaction in intramuscular injection application. Material method: The data of the research were collected using "Sociodemographic Characteristics Form", "Visual Comparison Scale (VAS-VAS)", "Satisfaction Assessment Scale (MDS)" and "Visual Analog Anxiety Scale (VAS-A)". will be collected using . Results: Findings will be presented in tables. Conclusion and recommendations: As a result, it is expected that the use of stress balls and virtual reality glasses in intramuscular application will be positive.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2024
Shorter than P25 for not_applicable
1 active site
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
First Submitted
Initial submission to the registry
July 10, 2024
CompletedFirst Posted
Study publicly available on registry
July 22, 2024
CompletedStudy Start
First participant enrolled
July 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 23, 2024
CompletedOctober 4, 2024
October 1, 2024
2 months
July 10, 2024
October 3, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
Visual Comparison Scale-Assessing pain with Visual Analog Scale
According to VAS, pain intensity is rated as "no pain" as 0 points and "the worst pain imaginable" as 10 points (Eti Aslan, 2002). Pain intensity ranges determined by VAS; A score below 3 points was defined as mild pain, between 3 and 6 points as moderate pain, and above 6 points as severe pain.
1 minute after application
Assessing anxiety level with the Visual Analog Anxiety Scale
It is a measurement tool with a length of 10 cm, representing 0 points for "no anxiety" and 10 points for "I feel a lot of anxiety", and its evaluation is scored between 0-10. As the patient's anxiety level approaches 10, it indicates that his anxiety increases.
Before application and 1 minute after application
Evaluating patient satisfaction with the Satisfaction Rating Scale
Patients' post-injection satisfaction was evaluated using a scale consisting of a 100 mm long vertical line with the words "Very Satisfied" on one end and "Not at all satisfied" on the other end.
1 minute after application
Study Arms (3)
Control Group
NO INTERVENTIONVoluntary Information and Consent Form, Patient Information Form and Visual Analogue Anxiety Scale will be filled out. Standard injection practice will be applied. Visual Comparison Scale (VAS-VAS), Satisfaction Assessment Scale (MDS) and Visual Analog Anxiety Scale (VAS-A) will be filled out within one minute after the procedure.
Virtual Reality Glasses
EXPERIMENTALVoluntary Information and Consent Form, Patient Information Form and Visual Analogue Anxiety Scale will be filled out. The individual will be shown a video containing relaxing nature images via VR. Intramuscular injection will begin three minutes after the individual starts watching the video, and the procedure will be performed while continuing to watch the video. Visual Comparison Scale (VAS-VAS), Satisfaction Assessment Scale (MDS) and Visual Analog Anxiety Scale (VAS-A) will be completed within one minute after the procedure.
Stress ball
EXPERIMENTALVoluntary Information and Consent Form, Patient Information Form and Visual Analogue Anxiety Scale will be filled out. The individual will be given a stress ball on the side where the intramuscular injection will be administered. Three minutes after the individual starts squeezing the ball, the intramuscular injection will begin and the procedure will be performed while squeezing the ball. Visual Comparison Scale (VAS-VAS), Satisfaction Assessment Scale (MDS) and Visual Analog Anxiety Scale (VAS-A) will be filled out within one minute after the procedure.
Interventions
A video containing relaxing nature images will be shown to a group via VR. Intramuscular injection will begin three minutes after the individual starts watching the video, and the procedure will be performed while continuing to watch the video.
One group will be given a stress ball in the hand on the side where the intramuscular injection will be administered. Three minutes after the individual starts squeezing the ball, intramuscular injection will begin and the procedure will be performed while squeezing the ball.
Eligibility Criteria
You may qualify if:
- Being over 18 years old,
- Having a body mass index (BMI) between 18.5 and 30,
- No scar, incision, lipodystrophy or infection at the injection site
- Pain, fear etc. Not having any disease that prevents perception of variables (loss of vision, hearing, sensation, cognitive impairment, stroke, diabetes mellitus, etc.)
- Not using centrally or peripherally acting analgesics or sedatives,
- No deficiency in arm limbs,
- No sensory or motor deficits,
- No history of diabetes,
- No vision, hearing or perception problems,
- Being oriented to place and time,
- Volunteering to participate in the research.
You may not qualify if:
- Development of drug-related allergy or other complications
- Wants to withdraw from the research
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Necmettin Erbakan University
Konya, Meram, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Asisstant
Study Record Dates
First Submitted
July 10, 2024
First Posted
July 22, 2024
Study Start
July 22, 2024
Primary Completion
September 18, 2024
Study Completion
September 23, 2024
Last Updated
October 4, 2024
Record last verified: 2024-10