Virtual RealityNCT06140368
Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection
A study testing virtual reality in people with Virtual Reality, run by Izmir Bakircay University at 1 site in Turkey (Türkiye).
Trial summary
To determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.This research was planned as a randomized controlled experimental type. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Virtual Reality
- What is being tested?
- virtual reality
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2023to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The procedure will be applied for the first time
- 18 years and over
- Able to understand and speak Turkish
- Able to understand verbal and written information given
- Having good cognitive abilities
- Without visual or hearing loss
- Patients who agreed to participate in the study
Who cannot join
- Those who do not understand or speak Turkish
- Does not understand verbal and written information
- Those with impaired cognitive abilities
- Epilepsy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Virtual Reality on Pain, Anxiety and Patient Comfort During Trigger Point Injection
To determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.This research was planned as a randomized controlled experimental type. The population of the research was planned to include patients who applied to the Algology polyclinic for trigger point injection. The sample of the research will consist of 150 patients who meet the sampling criteria and agree to participate in the research.Inclusion criteria: Trigger point injection applied for the first time, 18 years and over, understand and speak Turkish, understand verbal and written information given.Patients will be divided into two groups: experimental (virtual reality) and control groups.Data will be collected with the Case Report Form, State Anxiety Scale, General Comfort Scale and Visual Analog Scale.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.
Read the detailed description
Patients in the experimental group will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.Patients in the control group will continue routine practice.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.
- Conditions
- Virtual Reality
- Being tested
- virtual reality
- Keywords
- virtual reality, pain, trigger point injection., anxiety, comfort
- 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.
virtual realityBehavioural
During the trigger point injection, patients will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | During the trigger point injection, patients will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes. Receives: Behavioral: virtual reality |
| Control group | No intervention | Patients will not use virtual reality glasses during trigger point injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
State Anxiety Scale
The scale developed by Spielberger et al. aims to measure state and trait anxiety levels separately.The scores obtained from the scale vary between 20-80, and the total score between 20-39 indicates mild anxiety, between 40-59 indicates moderate anxiety, and between 60-79 indicates severe anxiety.
Measured: 10 minutes after procedure
General Comfort Scale
The scale, which was developed by Kolcaba in 2006 and has a total of 28 questions as 'Refreshing (9 items), Relaxation (9 items) and Overcoming Problems (10 items), consists of three sub-dimensions.The lowest value that can be taken is 1, which indicates low comfort, and the highest value, 6, indicates high comfort.
Measured: 10 minutes after procedure
Visual Analog Scale
It is aimed to determine the level of pain.0 means no pain and 10 means maximum pain
Measured: In the middle (10 minutes) of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2023
- Study start10 May 2023
- Primary completion10 Aug 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Virtual RealityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Izmir Bakircay University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Günay İsmailoğlu, Izmir Bakircay University
- Investigators
- Elif Günay İsmailoğlu, Principal investigator, Izmir Bakircay University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06140368
- Sponsor's protocol ID
- BU-SBF-EI-003
- Status last verified
- Dec 2025
- First submitted
- 10 Nov 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality on Pain, Anxiety and Patient Comfort During Trigger Point Injection
- ClinicalTrials.gov ID
- NCT06140368
- Acronym / sponsor ID
- BU-SBF-EI-003
- Conditions
- Virtual Reality
- Keywords
- virtual reality, pain, trigger point injection., anxiety, comfort
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Izmir Bakircay UniversityUniversity, hospital or other
- Study start
- 10 May 2023 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 20 Nov 2023 (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.
To determine the effects of virtual reality application during trigger point injection on patients' pain, anxiety and comfort levels.This research was planned as a randomized controlled experimental type. The population of the research was planned to include patients who applied to the Algology polyclinic for trigger point injection. The sample of the research will consist of 150 patients who meet the sampling criteria and agree to participate in the research.Inclusion criteria: Trigger point injection applied for the first time, 18 years and over, understand and speak Turkish, understand verbal and written information given.Patients will be divided into two groups: experimental (virtual reality) and control groups.Data will be collected with the Case Report Form, State Anxiety Scale, General Comfort Scale and Visual Analog Scale.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.
Detailed description
Patients in the experimental group will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes.Patients in the control group will continue routine practice.Patients' anxiety, comfort and pain levels will be evaluated before and after trigger point injection.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: virtual realityDuring the trigger point injection, patients will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes. |
| Control group | No intervention | –Patients will not use virtual reality glasses during trigger point injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The procedure will be applied for the first time
Key exclusion criteria (4 listed)
- Those who do not understand or speak Turkish
- Does not understand verbal and written information
- Those with impaired cognitive abilities
- Epilepsy
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 |
|---|---|---|
| virtual realityDuring the trigger point injection, patients will be shown videos that the patient wants to watch, such as nature and seaside walks, underwater videos, with music background, through virtual reality glasses for 10 minutes. | Behavioural | Experimental group |
Primary outcome
State Anxiety Scale
Time frame: 10 minutes after procedure
The scale developed by Spielberger et al. aims to measure state and trait anxiety levels separately.The scores obtained from the scale vary between 20-80, and the total score between 20-39 indicates mild anxiety, between 40-59 indicates moderate anxiety, and between 60-79 indicates severe anxiety.
General Comfort Scale
Time frame: 10 minutes after procedure
The scale, which was developed by Kolcaba in 2006 and has a total of 28 questions as 'Refreshing (9 items), Relaxation (9 items) and Overcoming Problems (10 items), consists of three sub-dimensions.The lowest value that can be taken is 1, which indicates low comfort, and the highest value, 6, indicates high comfort.
Visual Analog Scale
Time frame: In the middle (10 minutes) of the procedure
It is aimed to determine the level of pain.0 means no pain and 10 means maximum pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
Related trials for Virtual Reality
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruiting
Virtual Reality Multidomain Training for Older Adults With Cognitive Frailty
Cognitive Frailty
Not yet recruiting
Virtual Reality Training Dose for Arm Recovery After Stroke: Clinical and Blood Biomarker Responses
Stroke, Upper Extremity Paresis
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruiting
Advancing Cardiovascular Health Among Adolescents With Intellectual Disabilities: Co-Development of Technology Interventions to Enhance Physical Activity
Physical Activity, Intellectual Disabilities
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.
Elif Günay İsmailoğlu principal investigator
Izmir Bakircay University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality in people with Virtual Reality, run by Izmir Bakircay 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 7 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: finished, as of the sponsor's last update on 12 Dec 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
State Anxiety Scale (time frame: 10 minutes after 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 12 Dec 2025.