Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06551753
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-14
Brief Title:
Distraction-Based Interventions During Implanted Venous Port Catheter Needle Entry Virtual Reality Application
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Distraction-Based Interventions During Implanted Venous Port Catheter Needle Entry Virtual Reality Application
Status:
COMPLETED
Status Verified Date:
2024-08
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:
This study is a randomized controlled experimental study planned to examine the effect of virtual reality application during implanted venous port catheter needle insertion on patient satisfaction comfort level and time perception in cancer patients Distraction-based interventions used in symptom management of cancer patients are simple effective and cost-effective Distraction applications such as virtual reality glasses listening to music painting and daydreaming aim to focus attention on another stimulus Virtual reality application uses human-machine interfaces to focus the patient on a world other than their current environment with a three-dimensional virtual video changing their perception of space and time It has been shown that virtual reality applications reduce pain and anxiety increase patient satisfaction provide relief and positively affect vital parameters during procedural procedures such as bone marrow aspiration fine needle aspiration breast biopsy colonoscopy and transrectal prostate biopsy in cancer patients receiving chemotherapy
Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest ocean or space Virtual reality glasses are an application that is used to isolate the patient from hisher environment and includes a distraction method that allows the patient to focus on another world in three dimensions It is usually applied with glasses or headgear In addition the patient is prevented from perceiving the surrounding sounds by wearing headphones The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of timeVirtual reality applications a new technology can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention The widespread use of virtual reality applications in cancer care contributes to qualified nursing care This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices
Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest ocean or space Virtual reality glasses are an application that is used to isolate the patient from hisher environment and includes a distraction method that allows the patient to focus on another world in three dimensions It is usually applied with glasses or headgear In addition the patient is prevented from perceiving the surrounding sounds by wearing headphones The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of timeVirtual reality applications a new technology can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention The widespread use of virtual reality applications in cancer care contributes to qualified nursing care This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices
Detailed Description:
This study is a randomized controlled experimental study planned to examine the effect of virtual reality application during implanted venous port catheter needle insertion on patient satisfaction comfort level and time perception in cancer patients Distraction-based interventions used in symptom management of cancer patients are simple effective and cost-effective Distraction applications such as virtual reality glasses listening to music painting and daydreaming aim to focus attention on another stimulus Virtual reality application uses human-machine interfaces to focus the patient on a world other than their current environment with a three-dimensional virtual video changing their perception of space and time It has been shown that virtual reality applications reduce pain and anxiety increase patient satisfaction provide relief and positively affect vital parameters during procedural procedures such as bone marrow aspiration fine needle aspiration breast biopsy colonoscopy and transrectal prostate biopsy in cancer patients receiving chemotherapy
Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest ocean or space Virtual reality glasses are an application that is used to isolate the patient from hisher environment and includes a distraction method that allows the patient to focus on another world in three dimensions It is usually applied with glasses or headgear In addition the patient is prevented from perceiving the surrounding sounds by wearing headphones The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of time Virtual reality applications a new technology can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention The widespread use of virtual reality applications in cancer care contributes to qualified nursing care This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices
Research Inclusion Criteria
Those between the ages of 18-65
Those receiving active chemotherapy
Those who volunteer to participate in the research
Having an implantable venous port catheter
Those who will use virtual reality glasses for the first time
Exclusion Criteria from the Research
Presence of metastasis
Those receiving anxiolytic drug treatment
Those receiving antidepressant medication
People with communication hearing and vision problems
Having any psychiatric disorder
Those who used any analgesic medication at least 8 hours before
Those with migraine vertigo active nausea-vomiting headache dizziness problems Patient introductory information form satisfaction status evaluation scale general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools
Data Collection Phase
Before starting the research written informed consent will be obtained from cancer patients who agree to participate in the study and meet the inclusion criteria by explaining the purpose and rationale of the research In the research simple randomization method will be used to determine the sample number of intervention and control groups They will be assigned to the control n 35 and intervention n 35 groups by simple randomization method from a simple random numbers table prepared before the study Using the simple random numbers table patients assigned to the intervention group will be shown a three-minute video determined by the patients choice from video scenes containing nature images with sound shot at a 360-degree angle recorded on YouTube through a virtual reality headset throughout the procedure The application will begin as soon as the patient is positioned just before the procedure begins and will continue after the procedure is completed allowing them to experience a three-dimensional virtual reality application that lasts approximately 3 minutes Data will be collected by face-to-face interview with patients before and after the procedure Patient introductory information form satisfaction status evaluation scale general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools The study will be carried out in the same environment with a single nurse the same measurement tools will be used and procedures will be applied to both the control and experimental groups by the same nurse
Evaluation of Data
Descriptive and comparative statistics correlation and regression analyzes will be used to evaluate the data obtained from the study SPSS 250 Package Program will be used to analyze the data Categorical measurements will be presented as numbers and percentages and numerical measurements will be presented as mean and standard deviation median minimum and maximum values Chi-Square Test statistics will be used to compare categorical measurements between groups Whether numerical measurements provide normal distribution will be evaluated with the Kolmogrov-Smirnov Test In independent groups t test will be used and if the assumptions are not met Mann Whitney U test will be used Spearman correlation analyzes will be applied for correlation analyzes between data Statistical significance level will be accepted as p005 The research results will be evaluated and presented in the light of the literature
CENTERCENTERS WHERE THE RESEARCH WILL BE CONDUCTED Bursa Uludağ University Faculty of Medicine Hospital Medical Oncology Polyclinic
Virtual reality is a new technique developed thanks to the advancement of computer technology and started to be used in the field of health as a cognitive-behavioral method to relieve pain and relax the patient This method uses human-machine interfaces to give people the feeling of being in an interactive environment with virtual video in the forest ocean or space Virtual reality glasses are an application that is used to isolate the patient from hisher environment and includes a distraction method that allows the patient to focus on another world in three dimensions It is usually applied with glasses or headgear In addition the patient is prevented from perceiving the surrounding sounds by wearing headphones The most important feature that distinguishes virtual reality from other technological products such as television and video games is that it gives users the feeling of being in a different place The use of virtual reality glasses provides a positive environment for patients and provides a calming experience by changing their perception of time Virtual reality applications a new technology can make a positive difference in cancer care and increase the comfort and satisfaction levels of cancer patients This innovative method can be used as a complementary nursing approach in addition to standard care during implantable venous port catheter needle intervention The widespread use of virtual reality applications in cancer care contributes to qualified nursing care This study will be presented as an innovative method showing that virtual reality technologies can be incorporated into nursing practices
Research Inclusion Criteria
Those between the ages of 18-65
Those receiving active chemotherapy
Those who volunteer to participate in the research
Having an implantable venous port catheter
Those who will use virtual reality glasses for the first time
Exclusion Criteria from the Research
Presence of metastasis
Those receiving anxiolytic drug treatment
Those receiving antidepressant medication
People with communication hearing and vision problems
Having any psychiatric disorder
Those who used any analgesic medication at least 8 hours before
Those with migraine vertigo active nausea-vomiting headache dizziness problems Patient introductory information form satisfaction status evaluation scale general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools
Data Collection Phase
Before starting the research written informed consent will be obtained from cancer patients who agree to participate in the study and meet the inclusion criteria by explaining the purpose and rationale of the research In the research simple randomization method will be used to determine the sample number of intervention and control groups They will be assigned to the control n 35 and intervention n 35 groups by simple randomization method from a simple random numbers table prepared before the study Using the simple random numbers table patients assigned to the intervention group will be shown a three-minute video determined by the patients choice from video scenes containing nature images with sound shot at a 360-degree angle recorded on YouTube through a virtual reality headset throughout the procedure The application will begin as soon as the patient is positioned just before the procedure begins and will continue after the procedure is completed allowing them to experience a three-dimensional virtual reality application that lasts approximately 3 minutes Data will be collected by face-to-face interview with patients before and after the procedure Patient introductory information form satisfaction status evaluation scale general comfort scale-short form and time perception evaluation form during the procedure will be used as data collection tools The study will be carried out in the same environment with a single nurse the same measurement tools will be used and procedures will be applied to both the control and experimental groups by the same nurse
Evaluation of Data
Descriptive and comparative statistics correlation and regression analyzes will be used to evaluate the data obtained from the study SPSS 250 Package Program will be used to analyze the data Categorical measurements will be presented as numbers and percentages and numerical measurements will be presented as mean and standard deviation median minimum and maximum values Chi-Square Test statistics will be used to compare categorical measurements between groups Whether numerical measurements provide normal distribution will be evaluated with the Kolmogrov-Smirnov Test In independent groups t test will be used and if the assumptions are not met Mann Whitney U test will be used Spearman correlation analyzes will be applied for correlation analyzes between data Statistical significance level will be accepted as p005 The research results will be evaluated and presented in the light of the literature
CENTERCENTERS WHERE THE RESEARCH WILL BE CONDUCTED Bursa Uludağ University Faculty of Medicine Hospital Medical Oncology Polyclinic
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