Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06634615
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Patient Education and in the Operating Room Family Interview Practices on Patient Outcomes Using Virtual Reality in Cholecystectomy Patients a Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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 was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity anxiety and information need levels sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients The main questions it aims to answer are
Is there a significant difference in stress intensity anxiety and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery
Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery
Is there a significant difference in stress intensity anxiety and sleep quality levels at discharge of groups that received different VR interventions
What is the postoperative sleep quality of patients with low preoperative anxiety levels
What is the satisfaction of patients who received VR with the surgery preparation process The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control education educationinterview groups in accordance with the randomization list Face-to-face communication will be established with each patient in the ward on the day of hospitalization in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge Depending on the groups in which the patients are included they will be shown an educational video using virtual reality goggles andor will be allowed to meet with their families No application will be made to the control group and the ward routine will continue
Is there a significant difference in stress intensity anxiety and information need levels between patients who received and did not receive patient education with VR glasses in the ward before cholecystectomy surgery
Is there a significant difference in stress intensity and anxiety levels between patients who received and did not receive video family interviews with VR glasses in the operative waiting area before cholecystectomy surgery
Is there a significant difference in stress intensity anxiety and sleep quality levels at discharge of groups that received different VR interventions
What is the postoperative sleep quality of patients with low preoperative anxiety levels
What is the satisfaction of patients who received VR with the surgery preparation process The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control education educationinterview groups in accordance with the randomization list Face-to-face communication will be established with each patient in the ward on the day of hospitalization in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge Depending on the groups in which the patients are included they will be shown an educational video using virtual reality goggles andor will be allowed to meet with their families No application will be made to the control group and the ward routine will continue
Detailed Description:
Virtual reality VR is an interactive field that offers sensory experiences such as three-dimensional vision touch and hearing allowing people to dive into the virtual world and feel that they are in a different environment In healthcare services it is seen that the effect of virtual reality technology on various patient outcomes has been examined by watching nature videos training exercise applications museum tours with music and games This study was planned to be a randomized controlled experimental study to determine the effect of patient education and family interview practices using virtual reality on stress intensity anxiety and information need levels sleep quality and satisfaction with the preparation process for surgery in cholecystectomy patients GPower v3197 program was used to determine the sample size in the study and considering possible losses it was decided to include a total of 60 patients 20 in each group
During the data collection process it is planned to include a total of six patients in the preliminary pilot application two from the education group two from the educationinterview group and two from the control group for the comprehensibility and usability of the forms Patients who have undergone preliminary application will not be included in the study The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control education educationinterview groups in accordance with the randomization list Face-to-face communication will be established with each patient in the ward on the day of hospitalization in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge The first interview with the patients will be held in the patient room in the ward During this interview the patients will be invited to the study and the research will be explained Informed voluntary consent will be obtained from the patients who agree to participate in the study Depending on the groups in which the patients are included they will be shown an educational video using virtual reality goggles andor will be allowed to meet with their families Data will be collected with the Introductory Information Form Visual Analog Scale for Stress Amsterdam Preoperative Anxiety and Information Scale APAIS Richards Campbell Sleep Scale RCBS Virtual Reality Evaluation Form and Visual Analog Scale for Satisfaction Oculus Quest 2 VR glasses will be used as a virtual reality application tool in the study
The virtual family meeting will be initiated through the meeting link shared with the patients relative and VR glasses and computer connection will be provided with the BigScreen computer application Patients have a video call with their family in a 360 designed home environment The conversations are easily transmitted thanks to the internal speaker and microphone in the VR glasses In order to adjust the patients viewing angle to provide guidance when needed and to monitor communication the image the patient sees in the VR glasses will be monitored with the Meta Quest program installed on the researchers mobile phone The training video is a 2-3 minute animated video with visual and auditory elements and includes the ward nurse coming to the newly admitted patient in a patient room and giving information In order to prevent infection after each patients use the supporting pads straps and lenses of the virtual reality glasses will be disinfected with cleaner and allowed to dry It will be kept in its own box and offered to the other patients use
In the first phase of the study with the patients in the control group the data collection tools including the Introductory Information Form the Visual Analog Scale for Stress the Amsterdam Preoperative Anxiety and Information Scale APAIS and the Richard-Campbell Sleep Scale RCS will be filled in on the day of admission No intervention will be applied to the patients and routine procedures will continue After 30 minutes the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS again In the second phase of the study when the patients are taken to the preoperative waiting area of the operating room the data collection tools including the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled in At the end of the period in which the patient waits to be taken to the operation the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS again In the final phase of the study the Stress visual analog scale Amsterdam preoperative anxiety and information scale APAIS Richard-Campbell sleep scale RCUS and Satisfaction visual analog scale will be filled in the patient room before discharge on the morning of the first postoperative day
In the first phase of the study the patients in the patient education group will first fill out the data collection tools including the Introductory Information Form Stress visual analog scale Amsterdam preoperative anxiety and information scale APAIS and Richard-Campbell sleep scale RCUS on the day of admission Then a patient education video about laparoscopic cholecystectomy operation will be watched with virtual reality glasses 30 minutes after watching the education video patients will be asked to fill out the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS again In the second phase of the study when the patients are taken to the preoperative waiting area of the operating room the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS will be filled in the data collection tools including the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS At the end of the waiting period for the patient to be taken to the operation they will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS again In the last stage of the study on the morning of the first post-operative day before discharge the patient will be asked to fill out the data collection forms including the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS Richard-Campbell Sleep Scale RCUS Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale in the patient room
In the first stage of the study the patients in the Education Interview group will first fill out the data collection tools including the Introductory Information Form Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS and Richard-Campbell Sleep Scale RCUS on the day of admission Then a patient education video regarding laparoscopic cholecystectomy operation will be watched with virtual reality glasses After watching the training video patients will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS again 30 minutes later In the second phase of the study when patients are taken to the preoperative waiting area data collection tools including the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled out After the patient is put on virtual reality glasses and hisher vision is adjusted a video family interview will be initiated After the 5-minute virtual visit with the patients relatives the interview will be concluded and the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled out again In the last phase of the study data collection forms including the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS Richard-Campbell Sleep Scale RCUS Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale will be filled out in the patients room before discharge on the morning of the first postoperative day
During the data collection process it is planned to include a total of six patients in the preliminary pilot application two from the education group two from the educationinterview group and two from the control group for the comprehensibility and usability of the forms Patients who have undergone preliminary application will not be included in the study The patients participating in the study will be numbered according to the order of hospitalization and assigned to one of the control education educationinterview groups in accordance with the randomization list Face-to-face communication will be established with each patient in the ward on the day of hospitalization in the preoperative waiting area when they come to the operating room and in the ward on the day of discharge The first interview with the patients will be held in the patient room in the ward During this interview the patients will be invited to the study and the research will be explained Informed voluntary consent will be obtained from the patients who agree to participate in the study Depending on the groups in which the patients are included they will be shown an educational video using virtual reality goggles andor will be allowed to meet with their families Data will be collected with the Introductory Information Form Visual Analog Scale for Stress Amsterdam Preoperative Anxiety and Information Scale APAIS Richards Campbell Sleep Scale RCBS Virtual Reality Evaluation Form and Visual Analog Scale for Satisfaction Oculus Quest 2 VR glasses will be used as a virtual reality application tool in the study
The virtual family meeting will be initiated through the meeting link shared with the patients relative and VR glasses and computer connection will be provided with the BigScreen computer application Patients have a video call with their family in a 360 designed home environment The conversations are easily transmitted thanks to the internal speaker and microphone in the VR glasses In order to adjust the patients viewing angle to provide guidance when needed and to monitor communication the image the patient sees in the VR glasses will be monitored with the Meta Quest program installed on the researchers mobile phone The training video is a 2-3 minute animated video with visual and auditory elements and includes the ward nurse coming to the newly admitted patient in a patient room and giving information In order to prevent infection after each patients use the supporting pads straps and lenses of the virtual reality glasses will be disinfected with cleaner and allowed to dry It will be kept in its own box and offered to the other patients use
In the first phase of the study with the patients in the control group the data collection tools including the Introductory Information Form the Visual Analog Scale for Stress the Amsterdam Preoperative Anxiety and Information Scale APAIS and the Richard-Campbell Sleep Scale RCS will be filled in on the day of admission No intervention will be applied to the patients and routine procedures will continue After 30 minutes the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS again In the second phase of the study when the patients are taken to the preoperative waiting area of the operating room the data collection tools including the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled in At the end of the period in which the patient waits to be taken to the operation the patient will be asked to fill in the Visual Analog Scale for Stress and the Amsterdam Preoperative Anxiety and Information Scale APAIS again In the final phase of the study the Stress visual analog scale Amsterdam preoperative anxiety and information scale APAIS Richard-Campbell sleep scale RCUS and Satisfaction visual analog scale will be filled in the patient room before discharge on the morning of the first postoperative day
In the first phase of the study the patients in the patient education group will first fill out the data collection tools including the Introductory Information Form Stress visual analog scale Amsterdam preoperative anxiety and information scale APAIS and Richard-Campbell sleep scale RCUS on the day of admission Then a patient education video about laparoscopic cholecystectomy operation will be watched with virtual reality glasses 30 minutes after watching the education video patients will be asked to fill out the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS again In the second phase of the study when the patients are taken to the preoperative waiting area of the operating room the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS will be filled in the data collection tools including the Stress visual analog scale and Amsterdam preoperative anxiety and information scale APAIS At the end of the waiting period for the patient to be taken to the operation they will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS again In the last stage of the study on the morning of the first post-operative day before discharge the patient will be asked to fill out the data collection forms including the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS Richard-Campbell Sleep Scale RCUS Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale in the patient room
In the first stage of the study the patients in the Education Interview group will first fill out the data collection tools including the Introductory Information Form Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS and Richard-Campbell Sleep Scale RCUS on the day of admission Then a patient education video regarding laparoscopic cholecystectomy operation will be watched with virtual reality glasses After watching the training video patients will be asked to fill out the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS again 30 minutes later In the second phase of the study when patients are taken to the preoperative waiting area data collection tools including the Stress Visual Analog Scale and Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled out After the patient is put on virtual reality glasses and hisher vision is adjusted a video family interview will be initiated After the 5-minute virtual visit with the patients relatives the interview will be concluded and the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS will be filled out again In the last phase of the study data collection forms including the Stress Visual Analog Scale Amsterdam Preoperative Anxiety and Information Scale APAIS Richard-Campbell Sleep Scale RCUS Virtual Reality Evaluation Form and Satisfaction Visual Analog Scale will be filled out in the patients room before discharge on the morning of the first postoperative day
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