NCT06140368

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 10, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2023

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 20, 2023

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2023

Completed
Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 10, 2023

Last Update Submit

December 5, 2025

Conditions

Keywords

virtual realitypaintrigger point injection.anxietycomfort

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

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.

Behavioral: virtual reality

Control group

NO INTERVENTION

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

Interventions

virtual realityBEHAVIORAL

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.

Experimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The procedure will be applied for the first time
  • 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

You may not qualify if:

  • Those who do not understand or speak Turkish
  • Does not understand verbal and written information
  • Those with impaired cognitive abilities
  • Epilepsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elif Günay İsmailoğlu

Izmir, Menemen, 35160, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainAnxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Elif Günay İsmailoğlu

    Izmir Bakircay University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 10, 2023

First Posted

November 20, 2023

Study Start

May 10, 2023

Primary Completion

August 10, 2023

Study Completion

December 10, 2023

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations