NCT06512909

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

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 10, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 22, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

July 22, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2024

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2024

Completed
Last Updated

October 4, 2024

Status Verified

October 1, 2024

Enrollment Period

2 months

First QC Date

July 10, 2024

Last Update Submit

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 INTERVENTION

Voluntary 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

EXPERIMENTAL

Voluntary 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.

Other: Virtual Reality Glasses Application

Stress ball

EXPERIMENTAL

Voluntary 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.

Other: Stress Ball Application

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.

Virtual Reality Glasses

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.

Stress ball

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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

Locations