- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06140368
Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection
December 5, 2025 updated by: Elif Günay İsmailoğlu, Izmir Bakircay University
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.
Study Overview
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 Type
Interventional
Enrollment (Actual)
84
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Menemen
-
Izmir, Menemen, Turkey (Türkiye), 35160
- Elif Günay İsmailoğlu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Those who do not understand or speak Turkish
- Does not understand verbal and written information
- Those with impaired cognitive abilities
- Epilepsy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental group
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.
|
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.
|
|
No Intervention: Control group
Patients will not use virtual reality glasses during trigger point injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 minutes after procedure
|
|
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.
|
10 minutes after procedure
|
|
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
|
In the middle (10 minutes) of the procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Elif Günay İsmailoğlu, Izmir Bakircay University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 10, 2023
Primary Completion (Actual)
August 10, 2023
Study Completion (Actual)
December 10, 2023
Study Registration Dates
First Submitted
November 10, 2023
First Submitted That Met QC Criteria
November 16, 2023
First Posted (Actual)
November 20, 2023
Study Record Updates
Last Update Posted (Actual)
December 12, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BU-SBF-EI-003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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