Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection

Virtual Reality Clinical Trial

Official title:

The Effect of Virtual Reality on Pain, Anxiety and Patient Comfort During Trigger Point Injection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06140368
• Other study ID #: BU-SBF-EI-003
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2023
• Est. completion date: December 10, 2023

Study information

• Verified date: November 2023
• Source: Izmir Bakircay University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: December 10, 2023
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Virtual Reality

Intervention

Behavioral:
• virtual reality
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.

Locations

Country	Name	City	State
Turkey	Elif Günay Ismailoglu	Izmir	Menemen

Sponsors (1)

Lead Sponsor	Collaborator
Izmir Bakircay University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 minutes after procedure
Primary	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.	10 minutes after procedure
Primary	Visual Analog Scale	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