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Clinical Trials/NCT06512909
NCT06512909CompletedNot Applicable

Examining the Effects of Virtual Reality Glasses and Stress Ball Application on Pain, Anxiety and Patient Satisfaction in Intramuscular Injection Application: Randomized Controlled Study

Necmettin Erbakan University2 sites in 2 countries120 target enrollmentStarted: July 22, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
2
Primary Endpoint
Assessing anxiety level with the Visual Analog Anxiety Scale

Study Overview

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.

Detailed Description

Medication management is one of the basic nursing functions and these practices require knowledge and skills. Nurses administer medications via enteral and parenteral routes within the scope of their therapeutic roles. Among these applications, intravenous, subcutaneous, intradermal and intramuscular (IM) drug applications are parenteral drug application methods and are among the application authority of nurses. IM injection is defined as administering the drug deep into muscle tissue. IM injection can be applied from four different regions: deltoid, ventrogluteal, laterofemoral and femoral. The nurse will decide which area will be injected; It decides by taking into account the patient's body mass index, amount of medication, muscle development and muscle ratio. In injection applications, trauma caused by the needle while entering the tissue, not keeping the angle of entry into the tissue constant, the patient's previous experiences and psychological factors related to the patient may cause pain and affect the patient-nurse relationship, patient care quality and patient satisfaction.Nurses can reduce the individual's injection-related pain with the correct injection technique. In the literature, it is stated that nurses use local anesthetic creams and oral tablets pharmacologically during invasive procedures, while non-pharmacologically they use music therapy, vibrating tourniquet, buzzy device, various palpation techniques (Helfer Skin Tap Technique, etc.), therapeutic touch, stress ball and It has been stated that they use various distraction techniques such as virtual reality glasses. It is seen that the frequency of use of virtual reality, one of these methods, has increased in recent years with the developments in the technological field.

Virtual reality causes something or a situation that does not actually exist to be felt as real by creating it in three dimensions with computers and other tools. It is if he or she is really present in the created world. Studies have found that virtual reality glasses are effective on pain and anxiety in different groups and in different invasive applications. One of the methods of diverting attention in pain and anxiety management is the application of a stress ball, which is one of the methods aimed at the sense of touch. Stress ball is an application based on the pain theory that focuses on cognitive pain and anxiety management and reduces attention to painful stimuli by drawing attention to a different area. In stress ball application, the perception of pain is reduced due to the increased mental orientation towards more salient stimuli, and therefore the level of anxiety decreases. The stress ball is a simple, reliable, inexpensive and easily accessible application that helps reduce patients' anxiety. The stress ball, which is one of the applications to divert attention, is also an effective method to ensure cognitive focus. In the literature, it is seen that stress ball application is generally used to reduce pain and anxiety. There is no study in the literature comparing virtual reality glasses and stress ball application in intramuscular injection application. 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.

H.4.1. Research Questions/Hypotheses: H1a: Virtual reality glasses, stress balls and intramuscular injections applied with standard methods affect patients' pain sensation at different levels. H1b: Virtual reality glasses, stress balls and intramuscular injections applied with standard methods affect patients' anxiety at different levels. H1c: Virtual reality glasses, stress balls and intramuscular injections applied with standard methods affect patients' satisfaction at different levels. Research Type: This research was planned as a triple blind-randomized controlled study. Place and Time of the Research: The research will be conducted with patients who applied to Meram Medical Faculty Hospital Emergency Department for treatment in July-August 2024. 35 nurses, 6 specialist physicians and 21 assistant physicians work in the emergency department. The emergency room consists of triage, isolation, trauma room, resuscitation, yellow area, green area, red area and special rooms. There is a stretcher in the triage room. In addition to 30 stretchers, there are 11 emergency observation, 5 intermediate intensive care and 9 critical care unit beds in the emergency department. There are two stretchers in the green area. Population and Sample of the Study: The population of the study will consist of patients who applied to the trauma area of Meram Medical Faculty Hospital Emergency Service between July and August 2024 to receive intramuscular tetanus vaccination. Before determining the sample of the study, a priori power analysis was performed in the GPOWER 3.1.9.7 Package Program based on analysis of variance in repeated measurements. It was determined that the number of samples required to exceed 90% of the power of the study with a 95% confidence interval, a significance level of 0.05 and a medium effect size was 108. Considering the possibility of data loss for various reasons, it was planned to include 120 patients in the study sample who met the research criteria (40: Control, 40: Virtual reality, 40: Stress ball).

Randomization: The study group of the research will be determined according to the inclusion and exclusion criteria. Patients who agree to participate in the study will be divided into three groups: two intervention groups and a control group. Patients will be randomly assigned to three groups: intervention-virtual reality glasses group, intervention-ball squeezing group, and control group. The assignment of patients to groups will be determined by the clinic nurse by drawing lots. Preliminary tests of the research will be applied after obtaining written consent from patients who meet the research criteria and agree to participate in the research. After the preliminary tests are administered, patients will be assigned to control and intervention groups by block randomization method.

Data Collection Tools Used in the Research The data of the research will be collected using the "Sociodemographic Characteristics Form", "Visual Comparison Scale (VAS-VAS)", Satisfaction Assessment Scale (MDS)" and "Visual Analog Anxiety Scale (VAS-A)".

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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.

Exclusion Criteria

  • Development of drug-related allergy or other complications
  • Wants to withdraw from the research

Outcomes

Primary Outcomes

Assessing anxiety level with the Visual Analog Anxiety Scale

Time Frame: Before application and 1 minute after application

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.

Evaluating patient satisfaction with the Satisfaction Rating Scale

Time Frame: 1 minute after application

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.

Visual Comparison Scale-Assessing pain with Visual Analog Scale

Time Frame: 1 minute after application

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Asude GÜNEY

Research Asisstant

Necmettin Erbakan University

Study Sites (2)

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