Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06605339
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Virtual Reality on Pain Fear and Emotional Experience During Port Needle Insertion
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Virtual Reality on Pain Fear and Emotional Experience During Port Needle Insertion in Pediatric Hematology and Oncology Patients
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:
None
Brief Summary:
In pediatric hematology-oncology patients the need for a central venous catheter may arise in some cases to provide treatment Totally implanted vascular access devices are known as ports and port catheters are commonly used due to their lower risk of infection To maintain the port system and prevent infection the port needle should be replaced every 5-7 days During the course of treatment pediatric hematology-oncology patients undergo frequently repeated procedures associated with high levels of pain and distress Pain and distress resulting from repeated procedures are often uncomfortable symptoms for pediatric patients and their families There are pharmacological and non-pharmacological methods to reduce pain and anxiety during port needle procedures in pediatric hematology-oncology patients One pharmacological method distraction increases pain tolerance by focusing attention away from the painful stimulus This technique is used as a powerful tool for pain and anxiety management in pediatric pain Virtual reality glasses used as a distraction method provide access to an interactive three-dimensional computer-simulated environment through a head-mounted device that blocks out real-world views It is stated that distraction with virtual reality is a beneficial non-pharmacological method for children during hospital-based needle applications for pediatric patients This study evaluated the effect of virtual reality on pain fear and emotional appearance related to needle procedures in pediatric hematology-oncology patients during port needle changes
Detailed Description:
The study was conducted at the Pediatric Hematology and Oncology Clinic of Afyonkarahisar Health Sciences University Health Practice and Research Center
Research Hypotheses
H1 There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes
H2 There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes
Randomization
A stratified randomization scheme was used for distributing the sample into groups Stratification was done based on gender female male age group 4-7 8-12 and port duration 1 month 1 month
Patients requiring port needle changes were assigned to groups according to the randomization scheme No additional intervention was made for patients in the control group they were observed during the procedure after obtaining consent Patients in the study group were introduced to the virtual headset and informed that they could watch a video using the virtual reality headset during the procedure The Epic Roller Coasters video game was initiated If the child wanted to remove the glasses during the procedure they were excluded from the study Before the procedure the fear score was determined by asking both the patient and the parent using the Childrens Fear Scale After the procedure the pain levels were evaluated independently by the child the mother the attending nurse and the researcher Following the intervention the childs emotional appearance was assessed by the nurse
Research Hypotheses
H1 There is a difference in pain and fear scores among patients who watch videos using virtual reality glasses during port needle changes
H2 There is a difference in emotional appearance scores among patients who watch videos using virtual reality glasses during port needle changes
Randomization
A stratified randomization scheme was used for distributing the sample into groups Stratification was done based on gender female male age group 4-7 8-12 and port duration 1 month 1 month
Patients requiring port needle changes were assigned to groups according to the randomization scheme No additional intervention was made for patients in the control group they were observed during the procedure after obtaining consent Patients in the study group were introduced to the virtual headset and informed that they could watch a video using the virtual reality headset during the procedure The Epic Roller Coasters video game was initiated If the child wanted to remove the glasses during the procedure they were excluded from the study Before the procedure the fear score was determined by asking both the patient and the parent using the Childrens Fear Scale After the procedure the pain levels were evaluated independently by the child the mother the attending nurse and the researcher Following the intervention the childs emotional appearance was assessed by the nurse
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