Ignite Creation Date:
2024-10-25 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06512909
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-10
Brief Title:
Effects of Virtual Reality Glasses and Stress Ball Application on Pain Anxiety and Patient Satisfaction in Intramuscular Injection Application
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Examining the Effects of Virtual Reality Glasses and Stress Ball Application on Pain Anxiety and Patient Satisfaction in Intramuscular Injection Application Randomized Controlled Study
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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 patients previous experiences and psychological factors related to the patient may cause pain and affect the patient-nurse relationship patient care quality and patient satisfactionNurses can reduce the individuals 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
H41 Research QuestionsHypotheses 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 3197 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 005 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
Patient Information Form This form was prepared using the researchers experiences and literature It consists of 9 questions such as age gender marital status educational status occupation body mass index experience of intramuscular injection into the deltoid muscle presence of fear of injection history of not giving injections or postponing injections Visual Comparison Scale-Visual Analog Scale VAS The VAS scale is a unidimensional scale widely used today to assess pain intensity Validity and reliability studies have been conducted for Türkiye According to VAS pain intensity was rated as 0 points as no pain and 10 points as worst pain imaginable Pain intensity ranges determined by VAS A score below 3 points was determined as mild pain between 3 and 6 points as moderate pain and above 6 points as severe pain The VAS scale will be administered to patients within 1 minute after injection to determine the severity of pain they feel during intramuscular injection Satisfaction Rating Scale MDS Satisfaction of the patients after the injection was evaluated using a scale consisting of a 100 mm long vertical line with the words Very Satisfied at one end and Very Dissatisfied at the other end Patients satisfaction will be evaluated within 1 minute after the injection
Visual Analog Anxiety Scale VAS-A It is a measurement tool that is 10 cm long represents no anxiety as 0 points I feel a lot of anxiety as 10 points and is scored between 0-10 As the patients anxiety level approaches 10 it indicates that his anxiety increases It has been reported in the literature that it is a successful scale in relieving patients symptoms and evaluating fast-acting drug treatments There is a concurrent validity correlation between the VAS-A and the Spielberger State Anxiety Inventory r04916 to r08219 This shows that although the VAS-A scale is short it is a reliable and accurate measurement tool The VAS-A scale will be administered to patients before and immediately after the injection Data Collection Data will be collected from patients admitted to the trauma area at the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital While data is being collected The patient will be interviewed informed about the research and written consent will be obtained from the patient Each patient will receive a tetanus shot only once A nurse will work with the researcher during the procedure All injections will be administered by the same nurse Virtual reality glasses and stress ball interventions will be applied in the research
Application tools Virtual Reality Glasses VR VR glasses help people get away from the environment they are in and focus their attention on the image or sound by watching the content andor listening with headphones Thanks to the special lenses inside the glasses the image is shown large and clear With the Bluetooth stereo headset feature of the glasses it is possible to block out ambient sounds and listen to the contents watched by the individual Thus the person experiences the feeling of being in a different environment by drawing his attention in a different direction thanks to the virtual environment he watches with virtual glasses When watching content loaded on a smartphone with virtual reality glasses the glasses easily provide the viewfinder distance required for panoramic vision by dividing the image into two equal windows Head-mounted VR glasses can be personalized thanks to their adjustable straps In particular the distance between the mobile phone and the lens is fixed according to the individual VR glasses have air vents that can dissipate the heat emitted by the smartphone When using glasses there is no need for any power or connection unit other than the phone The smartphones internet connection is only required to watch the content An Oculus Quest-2 VR headset will be used in the research These VR glasses are compatible with smartphones Android IOS To use the glasses the Meta Quest program will be downloaded to researchers mobile phones VR content will be selected from 3600 angle footage from YouTube
Stress Ball A stress ball is a soft toy usually no larger than 7 cm that is stuck in the hand and manipulated with the fingers to relieve stress and muscle tension or to exercise the muscles In addition to reducing stress it is also used in physical therapy Some stress balls are made from closed-cell polyurethane foam Polyurethane is frequently preferred in the use of stress balls due to its ability to immediately return to its original shape In this study a stress ball with a flat surface seven cm in diameter made of soft material can be squeezed in the hand and returns to its original state when squeezed and released will be used
Research Variables Dependent variables Visual Comparison Scale mean score Satisfaction Evaluation Scale mean score Visual Analogue Anxiety Scale mean score Independent variables Sociodemographic Characteristics Virtual reality and ball squeezing method Ethical Dimension of the Research Subjects of the research purpose duration plan Where and how the data will be used will be explained to the patients included in the study In line with the principles of volunteering and willingness verbal and written consent will be obtained by reading the Voluntary Information and Consent Form In line with the principle of autonomy patients and their relatives will be informed that they can withdraw from the study at any time regardless of whether there is a reason to do so Permission will be obtained from the institution where the research will be conducted and the nurse who will work in the clinic will be informed about the research Limitations of the Study The study is limited to patients who will be administered intramuscular tetanus vaccine by applying to the trauma area at the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital The data obtained as a result of the research can be generalized to this group Statistical Evaluation of Data Data will be analyzed with IBM SPSS 22 package program For quantitative data mean standard deviation median interquartile range minimum and maximum values categorical data will be presented as frequency percentage The suitability of the data for normal distribution will be determined Chi-square test Kruskal Wallis test Analysis of Variance and t test will be used in independent groups to compare categorical variables according to groups It will be used in Tukey and Scheffe posthoc analyses The significance level will be accepted as p005
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
H41 Research QuestionsHypotheses 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 3197 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 005 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
Patient Information Form This form was prepared using the researchers experiences and literature It consists of 9 questions such as age gender marital status educational status occupation body mass index experience of intramuscular injection into the deltoid muscle presence of fear of injection history of not giving injections or postponing injections Visual Comparison Scale-Visual Analog Scale VAS The VAS scale is a unidimensional scale widely used today to assess pain intensity Validity and reliability studies have been conducted for Türkiye According to VAS pain intensity was rated as 0 points as no pain and 10 points as worst pain imaginable Pain intensity ranges determined by VAS A score below 3 points was determined as mild pain between 3 and 6 points as moderate pain and above 6 points as severe pain The VAS scale will be administered to patients within 1 minute after injection to determine the severity of pain they feel during intramuscular injection Satisfaction Rating Scale MDS Satisfaction of the patients after the injection was evaluated using a scale consisting of a 100 mm long vertical line with the words Very Satisfied at one end and Very Dissatisfied at the other end Patients satisfaction will be evaluated within 1 minute after the injection
Visual Analog Anxiety Scale VAS-A It is a measurement tool that is 10 cm long represents no anxiety as 0 points I feel a lot of anxiety as 10 points and is scored between 0-10 As the patients anxiety level approaches 10 it indicates that his anxiety increases It has been reported in the literature that it is a successful scale in relieving patients symptoms and evaluating fast-acting drug treatments There is a concurrent validity correlation between the VAS-A and the Spielberger State Anxiety Inventory r04916 to r08219 This shows that although the VAS-A scale is short it is a reliable and accurate measurement tool The VAS-A scale will be administered to patients before and immediately after the injection Data Collection Data will be collected from patients admitted to the trauma area at the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital While data is being collected The patient will be interviewed informed about the research and written consent will be obtained from the patient Each patient will receive a tetanus shot only once A nurse will work with the researcher during the procedure All injections will be administered by the same nurse Virtual reality glasses and stress ball interventions will be applied in the research
Application tools Virtual Reality Glasses VR VR glasses help people get away from the environment they are in and focus their attention on the image or sound by watching the content andor listening with headphones Thanks to the special lenses inside the glasses the image is shown large and clear With the Bluetooth stereo headset feature of the glasses it is possible to block out ambient sounds and listen to the contents watched by the individual Thus the person experiences the feeling of being in a different environment by drawing his attention in a different direction thanks to the virtual environment he watches with virtual glasses When watching content loaded on a smartphone with virtual reality glasses the glasses easily provide the viewfinder distance required for panoramic vision by dividing the image into two equal windows Head-mounted VR glasses can be personalized thanks to their adjustable straps In particular the distance between the mobile phone and the lens is fixed according to the individual VR glasses have air vents that can dissipate the heat emitted by the smartphone When using glasses there is no need for any power or connection unit other than the phone The smartphones internet connection is only required to watch the content An Oculus Quest-2 VR headset will be used in the research These VR glasses are compatible with smartphones Android IOS To use the glasses the Meta Quest program will be downloaded to researchers mobile phones VR content will be selected from 3600 angle footage from YouTube
Stress Ball A stress ball is a soft toy usually no larger than 7 cm that is stuck in the hand and manipulated with the fingers to relieve stress and muscle tension or to exercise the muscles In addition to reducing stress it is also used in physical therapy Some stress balls are made from closed-cell polyurethane foam Polyurethane is frequently preferred in the use of stress balls due to its ability to immediately return to its original shape In this study a stress ball with a flat surface seven cm in diameter made of soft material can be squeezed in the hand and returns to its original state when squeezed and released will be used
Research Variables Dependent variables Visual Comparison Scale mean score Satisfaction Evaluation Scale mean score Visual Analogue Anxiety Scale mean score Independent variables Sociodemographic Characteristics Virtual reality and ball squeezing method Ethical Dimension of the Research Subjects of the research purpose duration plan Where and how the data will be used will be explained to the patients included in the study In line with the principles of volunteering and willingness verbal and written consent will be obtained by reading the Voluntary Information and Consent Form In line with the principle of autonomy patients and their relatives will be informed that they can withdraw from the study at any time regardless of whether there is a reason to do so Permission will be obtained from the institution where the research will be conducted and the nurse who will work in the clinic will be informed about the research Limitations of the Study The study is limited to patients who will be administered intramuscular tetanus vaccine by applying to the trauma area at the emergency department of Necmettin Erbakan University Faculty of Medicine Hospital The data obtained as a result of the research can be generalized to this group Statistical Evaluation of Data Data will be analyzed with IBM SPSS 22 package program For quantitative data mean standard deviation median interquartile range minimum and maximum values categorical data will be presented as frequency percentage The suitability of the data for normal distribution will be determined Chi-square test Kruskal Wallis test Analysis of Variance and t test will be used in independent groups to compare categorical variables according to groups It will be used in Tukey and Scheffe posthoc analyses The significance level will be accepted as p005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None