Effect of Virtual Reality Distraction on Pain, Anxiety, Vital Signs in Patients Undergoing Lumbar Puncture

NCT07044856 | Active Not Recruiting DMC

• 1 other identifier: IU-HEM-NT-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Puncture; Virtual Reality; Distraction

Keywords

lumbar puncture; virtual reality; pain; anxiety; vital sings

Outcome Measures

Primary Outcomes (3)

• Visual Analog Skala

  It measures the intensity of pain in the patient. VAS is a scale with two different names on a 10 cm long vertical or horizontal line (0=no pain, 10=most severe pain). The patient is asked to mark the point on this line that corresponds to the intensity of pain he feels. The distance between the marked point and the lowest end of the line (0=no pain) is measured in centimeters and the numerical value found indicates the intensity of pain in the patient. An increase in the score obtained from the scale in the evaluation indicates an increase in pain.

  The scale will be applied 15 minutes after the procedure

• State Anxiety Scale

  The scale consists of the State Anxiety Scale, which determines how an individual feels at a certain moment and condition, and the Trait Anxiety Scale, which determines how an individual feels regardless of the situation and condition they are in. The State Anxiety Scale, which is structured to measure what is felt at that moment, will be used in this study. The State Anxiety Scale consists of 20 questions on a four-point Likert type. The expressions in the State Anxiety Scale are evaluated as none at all 1 point, a little 2 points, a lot 3 points, and completely 4 points. The scale score varies between 20-80, and an increase in the score obtained from the scale indicates an increase in the level of anxiety. A total of 0-19 points from the individual indicates no anxiety, 20-39 points indicate mild anxiety, 40-59 points indicate moderate anxiety, and 60-79 points indicate severe anxiety. It is stated that individuals who score above 60 on the State Anxiety Scale need professional help

  The scale will be applied 15 minutes after the procedure

• Vital Signs Form

  The Vital Signs Form, prepared by the researcher by scanning the literature, is a form in which the patient's vital signs (blood pressure, pulse, respiration, oxygen saturation) will be taken and recorded before and after the procedure.

  The scale will be applied 15 minutes after the procedure

Secondary Outcomes (1)

• Virtual Reality Glasses Application Satisfaction Form

  The scale will be applied 15 minutes after the procedure

Study Arms (2)

virtual reality experimental group

EXPERIMENTAL

Before the procedure, the patient's vital signs will be checked, and pain and anxiety will be assessed. This group will be shown a video using virtual reality glasses during the lumbar puncture procedure. After the intervention, the patient's vital signs will be checked again, and pain and anxiety will be assessed.

Behavioral: distraction with virtual reality

control group

NO INTERVENTION

Before the procedure, the patient's vital signs will be checked and pain and anxiety will be assessed. No intervention will be made during the lumbar puncture procedure in this group. After the procedure, the patient's vital signs will be checked again and pain and anxiety will be assessed.

Interventions

distraction with virtual reality BEHAVIORAL

Before the procedure, the patient's vital signs will be checked and pain and anxiety will be assessed. This group will be shown a video using virtual reality glasses during the lumbar puncture procedure. After the intervention, the patient's vital signs will be checked again and pain and anxiety will be assessed.

virtual reality experimental group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Volunteering to participate in the study
• years of age and older
• No psychiatric problems
• No vision or hearing problems
• Able to communicate in Turkish
• No open wounds, cellulitis, infection or bleeding in the area where the application will be made
• No diagnosis of epilepsy, head and neck cancer or vertigo
• No acute or chronic pain

You may not qualify if:

• Individuals who have pain before the procedure and use any analgesic medication,
• Those who have chronic pain or anxiety disorder,
• Those who use anxiolytic and/or sedative medication,
• Those who do not agree to participate in the study will not be included in the study.

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

İnönü Üniversitesi Turgut Özal Tıp Merkezi

Malatya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients who will be included in the study will know which group they have been assigned to.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: master of science

Model Details: The study has a randomized controlled experimental study design.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: July 1, 2025
• Study Start: April 1, 2025
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)