Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-01-02 @ 1:42 AM
Study NCT ID:
NCT07044856
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-01
First Post:
2025-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Virtual Reality Distraction on Pain, Anxiety, Vital Signs in Patients Undergoing Lumbar Puncture
Sponsor:
Inonu University
Organization:
Study Overview
Official Title:
The Effect of Distraction With the Help of Virtual Reality on Pain, Anxiety and Vital Signs in Patients Undergoing Lumbar Puncture
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Lumbar puncture (LP) is one of the most frequently applied interventional procedures in the clinical field. It is still used as the gold standard diagnostic tool in some infectious and non-infectious diseases. Its use in treatment also increases the clinical importance of lumbar puncture . Due to its wide range of indications, LP is a procedure that requires a professional approach in nursing care . Patients may feel anxious at every stage of the procedure. Pain and fear may be experienced due to the anesthesia procedure and needle movements during the procedure . Having to maintain the fetal position during the procedure may cause anxiety. This situation may result in deterioration in vital signs later on . Considering all these problems, this study was planned considering that distraction with the help of virtual reality in the nursing care of patients undergoing LP will have a positive effect on pain, anxiety and vital signs. The fact that there is no experimental study in the literature investigating the effect of virtual reality on pain, anxiety and vital signs during LP constitutes the strong and original aspect of the study. The aim of the study was to evaluate the effects of virtual reality on pain, anxiety and vital signs in patients undergoing lumbar puncture.
Detailed Description:
Lumbar puncture (LP) is a procedure performed by entering the subarachnoid space through the lumbar 3-4 or lumbar 4-5 vertebral spaces for diagnosis and treatment. LP is indicated for the diagnosis of many diseases such as benign intracranial hypertension, subarachnoid hemorrhage, seizure disorders, cognitive disorders, movement disorders, abnormal radiological imaging, cancer-related diseases, fever, encephalitis, bacterial meningitis or multiple sclerosis, and for therapeutic applications such as intracranial pressure management . However, patients may experience the procedure as uncomfortable and sometimes painful . Pain during anesthesia, the patient having to hold their position (fetal position) fixed, the needle making waves in the CSF, and pain when the needle touches the nerves going to the leg or hip are among the situations that cause discomfort to the patient during LP . Whether for diagnostic or therapeutic purposes, the LP procedure can cause pain, fear and anxiety in patients . There have been different definitions of virtual reality since its first appearance. Zhang defined virtual reality as a virtual environment consisting of different sensory stimuli by combining computer software and hardware. Virtual reality used in health services has been defined as an interactive, entertaining and three-dimensional visual feedback treatment and education tool. Virtual reality studies have had different purposes and goals for their use in the health field. When the developed applications and studies are examined, virtual reality has been used for different purposes such as training of healthcare personnel, surgical simulations, auxiliary tools for treatment methods, and physical therapy simulations. In the literature, we come across studies where virtual reality is used to cope with situations that may have negative effects on the patient such as pain, anxiety, and fear that may occur due to medical procedures. Virtual reality applications have been successfully applied and positive results have been obtained in distracting attention, which is one of the non-pharmacological methods in pain management . There are no sufficient studies in the literature regarding the problems that the patient may encounter during the lumbar puncture procedure. Researchers' interest in studies focusing more on post-procedural complications may lead to neglecting the negative experiences experienced by patients during the procedure. Pain during anesthesia, fear related to the procedure, and anxiety related to the procedure are among the negative experiences experienced by patients during lumbar puncture. In order to better manage this process, nurses can keep the pain and anxiety under control during the procedure by distracting the patients and prevent deterioration of their vital signs. In parallel with the rapid advancement of technology, nursing science is also renewing itself and showing interest in current approaches. With virtual reality technology, patients are isolated from their sensory environment and transported to a new environment prepared for them. With this distraction method, the patient's perception of the procedure currently being performed decreases and their tolerance for negative experiences related to the procedure increases. This study was planned considering that virtual reality application would be effective in solving problems that may develop during lumbar puncture because it is simple, reliable, and inexpensive.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: