Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649617
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-09
Brief Title:
The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients A Randomized Controlled Experimental 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:
Background and Aim Invasive procedures such as intravenous intramuscular and subcutaneous Injection practices are among the most frequently performed nursing interventions in ıntensive care units However although nursing interventions positively affect the clinical results of the patient they can cause anxiety and pain In recent years music therapy and virtual reality which are nonpharmacological methods have been widely used in reducing pain and anxiety Based on this information this study was conducted as a randomized controlled experimental to evaluate the effects of virtual reality and music therapy on physiological parameters and anxiety in nursing ınterventions applied to ıntensive care patients
MethodsThe research was conducted with 90 patient in intensive care unit The patients in the sample group were randomly determined by the researcher as Control Group Standard Procedure Music Therapy Group and Virtual Reality Group The selection of patients included in the study was made using a random number table Research data were collected using a structured patient information form VAS pain scale and state and trait anxiety inventoryThe data were analyzed using SPSS 25 program
Keywords music therapy virtual reality nursing interventions intensive care
MethodsThe research was conducted with 90 patient in intensive care unit The patients in the sample group were randomly determined by the researcher as Control Group Standard Procedure Music Therapy Group and Virtual Reality Group The selection of patients included in the study was made using a random number table Research data were collected using a structured patient information form VAS pain scale and state and trait anxiety inventoryThe data were analyzed using SPSS 25 program
Keywords music therapy virtual reality nursing interventions intensive care
Detailed Description:
This study was conducted as a Randomized Controlled Experimental to evaluate the Effects of Virtual Reality and Music Therapy on Physiological Parameters and Anxiety in Nursing Interventions Applied to Intensive Care Patients
Hypotheses of the Research H1 1 Virtual Reality and Music Therapy Improve Physiological Parameters in Nursing Interventions Applied to Intensive Care Patients
H1 2 Virtual Reality and Music Therapy in Nursing Interventions Applied to Intensive Care Patients reduces pain
H1 3 Virtual Reality and Music Therapy reduce anxiety in Nursing Interventions Applied to Intensive Care Patients
Variables of the Research The independent variables of the study are music therapy virtual reality technology and standard procedure explanation of the nursing intervention to the patient before the procedure
The dependent variables of the study are the physiological parameters pulse blood pressure fever pain and anxiety levels of the patients during nursing interventions
The intensive care unit of a foundation university hospital between May 2022 and July 2022 In order to determine the number of patients constituting the research sample a similar study 13 was taken as an example in the relevant literature and the power analysis G Power 31 software was used In this study the sample size was calculated as 84 with 28 participants in each group to reach a power level of 95 at a 05 effect size and 5 error level Considering the high power of the test and the losses in the study a total of 90 people were reached 30 in each group The patients in the sample group were randomly determined by the researcher as Control Group Standard Procedure Music Therapy Group and Virtual Reality Group The selection of patients included in the study was made using a random number table The randomization table was created by using the website httpstattrekcomstatisticsrandom-number-generatoraspx for randomization As a result the sample of the study consisted of 90 patients in total 30 participants in each patient group who were informed after the purpose of the study was explained and permission was obtained to participate in the study and who met the sample criteria of the study The sample criteria were the patient was over 18 years of age had no visual or hearing impairment had stable hemodynamic and physiological parameters pulse respiration blood pressure oxygen saturation pain was not intubated and volunteered for the studyResearch data were collected using a structured patient information form VAS pain scale and state and trait anxiety inventoryapplication the 3 groups of the study control virtual reality music therapy were randomly assigned to 3 halls of the intensive care unit Thus the application was performed on one group of patients in one hall All patients participating in the study filled out the Structured Patient Information Form Then the patients were divided into 3 groups The standard procedure verbal procedure explanation was applied to the control group patients The virtual reality group patients were shown 3-dimensional videos with a relaxation effect using virtual glasses The music therapy group patients were made to listen to the Büzürk makam a Turkish musical makam In this study while nursing interventions Intamuscular Intravenous Subcutaneous Injection were applied to all 3 groups of patients the physiological parameters fever pulse blood pressure respiration and oxygen saturation pain and anxiety levels of the patients were evaluated before and after the procedure
Application in Control Group Before the application of nursing interventions Intramuscular Intravenous Subcutaneous Injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated Then information was given about the nursing intervention to be performed as a standard procedure The nursing intervention was applied After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary for the patients Intramuscular Intravenous Subcutaneous Injection that application was applied No unnecessary procedure was applied After all the applications were completed virtual glasses or music therapy was applied to the volunteers from the control group in order to ensure the principle of equality which is one of the ethical principles
Application in Music Therapy Group Before the application of nursing interventions intramuscular intravenous subcutaneous injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated During the nursing intervention the patients were made to listen to Büzürk makam a Turkish musical makam After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary intramuscular intravenous subcutaneous injection that application was performed on the patients No unnecessary procedure was performed
Application in Virtual Reality Group Before the application of nursing interventions Intamuscular Intravenous Subcutaneous Injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated During the nursing intervention the patients watched 3D videos with relaxation effect with virtual glasses After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary Intamuscular Intravenous Subcutaneous Injection that application was performed on the patients No unnecessary procedure was performed
Ethical considerations Before starting the research permission was obtained from the Istanbul Beykent University Social and Human Sciences Scientific Research and Publication Ethics Board with the decision number 223 dated 09052022 Written permission was obtained from the institution where the research was conducted After the information about the research the patients who agreed to participate voluntarily were asked to read and sign the consent forms prepared for each group The researcher who completed the application phase of the research is a faculty member in the Department of Nursing Fundamentals
Data analysis The data obtained in the study were obtained using SPSS Statistical Package for Social Sciences for Windows 250 program was used for analysis Descriptive statistical methods were used for data evaluation as number percentage mean standard deviation Differences between proportions of categorical variables in independent groups were analyzed using Chi-Square and Fisher It was analyzed with exact tests T-test was used to compare quantitative continuous data between two independent groups Dependent groups t-test was used to compare within-group measurements
Hypotheses of the Research H1 1 Virtual Reality and Music Therapy Improve Physiological Parameters in Nursing Interventions Applied to Intensive Care Patients
H1 2 Virtual Reality and Music Therapy in Nursing Interventions Applied to Intensive Care Patients reduces pain
H1 3 Virtual Reality and Music Therapy reduce anxiety in Nursing Interventions Applied to Intensive Care Patients
Variables of the Research The independent variables of the study are music therapy virtual reality technology and standard procedure explanation of the nursing intervention to the patient before the procedure
The dependent variables of the study are the physiological parameters pulse blood pressure fever pain and anxiety levels of the patients during nursing interventions
The intensive care unit of a foundation university hospital between May 2022 and July 2022 In order to determine the number of patients constituting the research sample a similar study 13 was taken as an example in the relevant literature and the power analysis G Power 31 software was used In this study the sample size was calculated as 84 with 28 participants in each group to reach a power level of 95 at a 05 effect size and 5 error level Considering the high power of the test and the losses in the study a total of 90 people were reached 30 in each group The patients in the sample group were randomly determined by the researcher as Control Group Standard Procedure Music Therapy Group and Virtual Reality Group The selection of patients included in the study was made using a random number table The randomization table was created by using the website httpstattrekcomstatisticsrandom-number-generatoraspx for randomization As a result the sample of the study consisted of 90 patients in total 30 participants in each patient group who were informed after the purpose of the study was explained and permission was obtained to participate in the study and who met the sample criteria of the study The sample criteria were the patient was over 18 years of age had no visual or hearing impairment had stable hemodynamic and physiological parameters pulse respiration blood pressure oxygen saturation pain was not intubated and volunteered for the studyResearch data were collected using a structured patient information form VAS pain scale and state and trait anxiety inventoryapplication the 3 groups of the study control virtual reality music therapy were randomly assigned to 3 halls of the intensive care unit Thus the application was performed on one group of patients in one hall All patients participating in the study filled out the Structured Patient Information Form Then the patients were divided into 3 groups The standard procedure verbal procedure explanation was applied to the control group patients The virtual reality group patients were shown 3-dimensional videos with a relaxation effect using virtual glasses The music therapy group patients were made to listen to the Büzürk makam a Turkish musical makam In this study while nursing interventions Intamuscular Intravenous Subcutaneous Injection were applied to all 3 groups of patients the physiological parameters fever pulse blood pressure respiration and oxygen saturation pain and anxiety levels of the patients were evaluated before and after the procedure
Application in Control Group Before the application of nursing interventions Intramuscular Intravenous Subcutaneous Injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated Then information was given about the nursing intervention to be performed as a standard procedure The nursing intervention was applied After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State- Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary for the patients Intramuscular Intravenous Subcutaneous Injection that application was applied No unnecessary procedure was applied After all the applications were completed virtual glasses or music therapy was applied to the volunteers from the control group in order to ensure the principle of equality which is one of the ethical principles
Application in Music Therapy Group Before the application of nursing interventions intramuscular intravenous subcutaneous injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated During the nursing intervention the patients were made to listen to Büzürk makam a Turkish musical makam After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary intramuscular intravenous subcutaneous injection that application was performed on the patients No unnecessary procedure was performed
Application in Virtual Reality Group Before the application of nursing interventions Intamuscular Intravenous Subcutaneous Injection to the patients the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated During the nursing intervention the patients watched 3D videos with relaxation effect with virtual glasses After the application the patients physiological parameters fever pulse blood pressure respiration and oxygen saturation pain levels with VAS and anxiety levels with State -Trait Anxiety Scale were evaluated Whichever nursing intervention was necessary Intamuscular Intravenous Subcutaneous Injection that application was performed on the patients No unnecessary procedure was performed
Ethical considerations Before starting the research permission was obtained from the Istanbul Beykent University Social and Human Sciences Scientific Research and Publication Ethics Board with the decision number 223 dated 09052022 Written permission was obtained from the institution where the research was conducted After the information about the research the patients who agreed to participate voluntarily were asked to read and sign the consent forms prepared for each group The researcher who completed the application phase of the research is a faculty member in the Department of Nursing Fundamentals
Data analysis The data obtained in the study were obtained using SPSS Statistical Package for Social Sciences for Windows 250 program was used for analysis Descriptive statistical methods were used for data evaluation as number percentage mean standard deviation Differences between proportions of categorical variables in independent groups were analyzed using Chi-Square and Fisher It was analyzed with exact tests T-test was used to compare quantitative continuous data between two independent groups Dependent groups t-test was used to compare within-group measurements
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