Virtual Realityon Pain, Anxiety and Comfort During Trigger Point Injection

Sponsor

Izmir Bakircay University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT06140368

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

14.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Virtual Reality	Behavioral: virtual reality	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

May 10, 2023

Actual Primary Completion Date :

Aug 10, 2023

Anticipated Study Completion Date :

Dec 10, 2023

Arms and Interventions

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.	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.
No Intervention: Control group Patients will not use virtual reality glasses during trigger point injection.

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.

Behavioral: virtual reality

No Intervention: Control group

Patients will not use virtual reality glasses during trigger point injection.

Outcome Measures

Primary Outcome Measures

State Anxiety Scale [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 [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Elif Günay İsmailoğlu	İzmir	Menemen	Turkey	35160

Sponsors and Collaborators

Izmir Bakircay University

Investigators

Principal Investigator: Elif Günay İsmailoğlu, Izmir Bakircay University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elif Günay İsmailoğlu, Associate Professor, Izmir Bakircay University

ClinicalTrials.gov Identifier:

NCT06140368

Other Study ID Numbers:

BU-SBF-EI-003

First Posted:

Nov 20, 2023

Last Update Posted:

Nov 20, 2023

Last Verified:

Nov 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elif Günay İsmailoğlu, Associate Professor, Izmir Bakircay University

virtual reality

pain

trigger point injection.

anxiety

comfort

Study Results

No Results Posted as of Nov 20, 2023