Ignite Creation Date:
2024-10-25 @ 8:00 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604364
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Virtual Reality for Reducing Anxiety in Pediatric Orthopedic Surgery
Sponsor:
None
Organization:
None
Study Overview
Official Title:
realtà Aumentata Generatrice di Ansia Zero
Status:
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:
RAGAZ
Brief Summary:
This study titled RAGAZ Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery aims to see if using virtual reality VR can help children feel less anxious and experience less pain during minor orthopedic surgeries The research will compare the effects of VR to the usual pre-surgery sedative medication
Study Hypotheses
The researchers hypothesize that using VR will
1 Reduce anxiety levels in children before and after surgery compared to standard sedative medication
Who can participate
Children aged 7 to 12 years
Undergoing minor orthopedic surgery lasting less than 60 minutes
Eligible for regional anesthesia
Study Process
Participants will be randomly assigned to one of two groups
1 VR Group Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery
2 Standard Care Group Children will receive standard sedative medication before surgery
The study will measure
Levels of anxiety before and after surgery using a specific anxiety meter CAM-S
Stress hormone levels cortisol adrenaline noradrenaline from blood samples
Pain levels at different times after surgery
How well children cooperate during medical procedures
Satisfaction levels of children parents and surgeons
The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna Italy It is a non-profit study funded by donations
The goal is to find out if VR can reduce the need for sedatives decrease anxiety and pain and improve the overall surgical experience for children
Study Hypotheses
The researchers hypothesize that using VR will
1 Reduce anxiety levels in children before and after surgery compared to standard sedative medication
Who can participate
Children aged 7 to 12 years
Undergoing minor orthopedic surgery lasting less than 60 minutes
Eligible for regional anesthesia
Study Process
Participants will be randomly assigned to one of two groups
1 VR Group Children will use VR headsets to immerse themselves in calming virtual environments before and during the surgery
2 Standard Care Group Children will receive standard sedative medication before surgery
The study will measure
Levels of anxiety before and after surgery using a specific anxiety meter CAM-S
Stress hormone levels cortisol adrenaline noradrenaline from blood samples
Pain levels at different times after surgery
How well children cooperate during medical procedures
Satisfaction levels of children parents and surgeons
The study is being conducted by IRCCS - Istituto Ortopedico Rizzoli in Bologna Italy It is a non-profit study funded by donations
The goal is to find out if VR can reduce the need for sedatives decrease anxiety and pain and improve the overall surgical experience for children
Detailed Description:
Detailed Description
This study titled RAGAZ Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery aims to evaluate the effectiveness of virtual reality VR in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication
Purpose of the Study
The primary objective of this study is to determine whether VR can provide better control of anxiety in pediatric patients before and after anesthetic and surgical procedures The study will also assess whether VR can reduce the need for sedative and pain-relief medications thereby minimizing potential side effects and improving recovery times
Study Hypotheses
The researchers hypothesize that VR will
1 Significantly reduce anxiety levels in children before and after surgery compared to standard sedation practices
2 Lower stress hormone levels cortisol adrenaline noradrenaline associated with surgical procedures
3 Reduce the perceived pain during and after surgery
4 Decrease the overall consumption of sedative and analgesic medications
5 Good patient compliance during medical procedures
6 Good satisfaction levels for patients their parents and healthcare providers
Study Design
This is a non-profit randomized controlled trial conducted at the IRCCS - Istituto Ortopedico Rizzoli in Bologna Italy The study will include 50 children aged 7 to 12 years who are candidates for minor orthopedic surgeries lasting less than 60 minutes Participants will be randomly assigned to one of two groups
1 VR Group Children in this group will use VR headsets to experience calming virtual environments such as underwater scenes or peaceful gardens The VR sessions will begin before the surgical procedure and continue through the perioperative period
2 Standard Care Group Children in this group will receive the usual care which includes pre-surgery sedation with midazolam a common sedative used to reduce anxiety
Procedures
Anxiety Assessment The Childrens Anxiety Meter-State CAM-S will be used to measure anxiety levels at multiple points preoperatively upon arrival at the operating room and at 3 6 and 24 hours postoperatively
Stress Hormone Levels Blood samples will be taken at the time of venipuncture to measure cortisol adrenaline and noradrenaline levels which are indicators of surgical stress
Pain Assessment Pain levels will be evaluated using the Faces Pain Scale-Revised FPS-R at various postoperative intervals 3 6 and 24 hours
Patient Compliance The Modified Induction Compliance Checklist MICC will be used to assess how well children comply with medical procedures such as venipuncture and anesthesia administration
Satisfaction Surveys Satisfaction levels of patients parents and surgeons will be recorded using a scale from 1 to 10 This will assess overall satisfaction with the VR intervention and the surgical experience
Expected Outcomes
The study aims to demonstrate that VR can effectively reduce perioperative anxiety and pain leading to a lower requirement for sedatives and analgesics By providing a non-pharmacological method to manage anxiety and pain VR could improve the overall surgical experience for pediatric patients and enhance recovery outcomes Additionally the study seeks to validate the feasibility and acceptability of VR as a standard practice in pediatric surgical settings
Study Timeline
The study is expected to last 24 months including patient enrollment data collection and analysis Each participant will be involved from the preoperative visit through the first 24 hours post-surgery The results will be analyzed and published to contribute to the growing body of evidence supporting the use of VR in medical procedures
Ethical Considerations
The study will be conducted following the principles of the Declaration of Helsinki and Good Clinical Practice GCP guidelines Informed consent will be obtained from all participants and their parents or guardians The privacy and confidentiality of all participants will be strictly maintained
This study has the potential to revolutionize the approach to managing perioperative anxiety and pain in pediatric patients offering a safe effective and enjoyable alternative to traditional sedative medications
This study titled RAGAZ Virtual Reality for Reducing Anxiety and Pain in Pediatric Orthopedic Surgery aims to evaluate the effectiveness of virtual reality VR in reducing perioperative anxiety and pain in children undergoing minor orthopedic surgeries The study will compare the use of VR headsets to the traditional method of pre-surgery sedation with medication
Purpose of the Study
The primary objective of this study is to determine whether VR can provide better control of anxiety in pediatric patients before and after anesthetic and surgical procedures The study will also assess whether VR can reduce the need for sedative and pain-relief medications thereby minimizing potential side effects and improving recovery times
Study Hypotheses
The researchers hypothesize that VR will
1 Significantly reduce anxiety levels in children before and after surgery compared to standard sedation practices
2 Lower stress hormone levels cortisol adrenaline noradrenaline associated with surgical procedures
3 Reduce the perceived pain during and after surgery
4 Decrease the overall consumption of sedative and analgesic medications
5 Good patient compliance during medical procedures
6 Good satisfaction levels for patients their parents and healthcare providers
Study Design
This is a non-profit randomized controlled trial conducted at the IRCCS - Istituto Ortopedico Rizzoli in Bologna Italy The study will include 50 children aged 7 to 12 years who are candidates for minor orthopedic surgeries lasting less than 60 minutes Participants will be randomly assigned to one of two groups
1 VR Group Children in this group will use VR headsets to experience calming virtual environments such as underwater scenes or peaceful gardens The VR sessions will begin before the surgical procedure and continue through the perioperative period
2 Standard Care Group Children in this group will receive the usual care which includes pre-surgery sedation with midazolam a common sedative used to reduce anxiety
Procedures
Anxiety Assessment The Childrens Anxiety Meter-State CAM-S will be used to measure anxiety levels at multiple points preoperatively upon arrival at the operating room and at 3 6 and 24 hours postoperatively
Stress Hormone Levels Blood samples will be taken at the time of venipuncture to measure cortisol adrenaline and noradrenaline levels which are indicators of surgical stress
Pain Assessment Pain levels will be evaluated using the Faces Pain Scale-Revised FPS-R at various postoperative intervals 3 6 and 24 hours
Patient Compliance The Modified Induction Compliance Checklist MICC will be used to assess how well children comply with medical procedures such as venipuncture and anesthesia administration
Satisfaction Surveys Satisfaction levels of patients parents and surgeons will be recorded using a scale from 1 to 10 This will assess overall satisfaction with the VR intervention and the surgical experience
Expected Outcomes
The study aims to demonstrate that VR can effectively reduce perioperative anxiety and pain leading to a lower requirement for sedatives and analgesics By providing a non-pharmacological method to manage anxiety and pain VR could improve the overall surgical experience for pediatric patients and enhance recovery outcomes Additionally the study seeks to validate the feasibility and acceptability of VR as a standard practice in pediatric surgical settings
Study Timeline
The study is expected to last 24 months including patient enrollment data collection and analysis Each participant will be involved from the preoperative visit through the first 24 hours post-surgery The results will be analyzed and published to contribute to the growing body of evidence supporting the use of VR in medical procedures
Ethical Considerations
The study will be conducted following the principles of the Declaration of Helsinki and Good Clinical Practice GCP guidelines Informed consent will be obtained from all participants and their parents or guardians The privacy and confidentiality of all participants will be strictly maintained
This study has the potential to revolutionize the approach to managing perioperative anxiety and pain in pediatric patients offering a safe effective and enjoyable alternative to traditional sedative medications
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