Lumbar PunctureNCT07044856
Effect of Virtual Reality Distraction on Pain, Anxiety, Vital Signs in Patients Undergoing Lumbar Puncture
A study testing distraction with virtual reality in people with Lumbar Puncture and Virtual Reality, run by Inonu University at 1 site in Turkey (Türkiye).
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Lumbar Puncture, Virtual Reality, Distraction
- What is being tested?
- distraction with virtual reality
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Volunteering to participate in the study
- 18 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İnönü Üniversitesi Turgut Özal Tıp Merkezi
Malatya
About this study
Official title: The Effect of Distraction With the Help of Virtual Reality on Pain, Anxiety and Vital Signs in Patients Undergoing Lumbar Puncture
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.
Read the 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.
- Conditions
- Lumbar Puncture, Virtual Reality, Distraction
- Being tested
- distraction with virtual reality
- Keywords
- lumbar puncture, virtual reality, pain, anxiety, vital sings
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
distraction with virtual realityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: The scale will be applied 15 minutes after the procedure
Secondary outcomes (1)
Virtual Reality Glasses Application Satisfaction Form
This form, prepared by the researcher by scanning the literature, consists of 3 questions planned to be applied to the experimental group after the intervention. Question 1: The satisfaction of the intervention group will be measured on a 10 cm long horizontal line with the help of VAS. (0=not satisfied at all, 10=very satisfied). The higher the score, the higher the satisfaction. Question 2 asks whether the intervention group would prefer virtual reality if a lumbar puncture were to be performed again. The answer is yes or no. The third question is the intervention group's question 'Would you recommend virtual reality to other patients who will undergo lumbar puncture?' The answer is given as yes or no.
Measured: The scale will be applied 15 minutes after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Apr 2025
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar PunctureStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study has a randomized controlled experimental study design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nazan Tasan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07044856
- Sponsor's protocol ID
- IU-HEM-NT-01
- Status last verified
- Jun 2025
- First submitted
- 19 May 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distraction With the Help of Virtual Reality on Pain, Anxiety and Vital Signs in Patients Undergoing Lumbar Puncture
- ClinicalTrials.gov ID
- NCT07044856
- Acronym / sponsor ID
- IU-HEM-NT-01
- Conditions
- Lumbar Puncture, Virtual Reality, Distraction
- Keywords
- lumbar puncture, virtual reality, pain, anxiety, vital sings
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The study has a randomized controlled experimental study design.
| Arm | Type | Receives |
|---|---|---|
| virtual reality experimental group | Experimental | Behavioral: distraction with virtual realityBefore 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. |
| 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. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Volunteering to participate in the study
- 18 years of age and older
- No psychiatric problems
- No vision or hearing problems
- Able to communicate in Turkish
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| distraction with virtual realityBefore 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. | Behavioural | virtual reality experimental group |
Primary outcome
Visual Analog Skala
Time frame: The scale will be applied 15 minutes after the procedure
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.
State Anxiety Scale
Time frame: The scale will be applied 15 minutes after the procedure
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
Vital Signs Form
Time frame: The scale will be applied 15 minutes after the procedure
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.
1 secondary outcome
Virtual Reality Glasses Application Satisfaction Form
Time frame: The scale will be applied 15 minutes after the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing distraction with virtual reality in people with Lumbar Puncture and Virtual Reality, run by Inonu University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Skala (time frame: The scale will be applied 15 minutes after the procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.