The Use of Virtual Reality Applications in Tension-Type Headaches

January 13, 2025 updated by: Safa Dönmez, Ankara City Hospital Bilkent

The Impact of Virtual Reality -Guided Visual and Auditory Therapy on Symptom Severity and Psychological Well-Being in Tension-Type Headache Patients: A Controlled Study

The primary aim of this research is to objectively assess the impact of virtual reality (VR) technology on pain symptoms in tension-type headache patients. This study is designed to understand the potential of VR in the treatment of tension-type headaches, exploring its ability to reduce pain severity and improve patients' quality of life.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Tension-type headache is a prevalent health issue that can cause significant discomfort to patients. The potential use of VR goggles as an effective alternative treatment option in these patients is crucial in clinical applications. The quality of life of tension-type headache patients is often affected. If VR goggle technology can enhance the quality of life for these patients, it would be a significant finding.

Additionally, our research may contribute more data to the scientific literature on the impact of VR goggle technology in headache treatment. This could assist future researchers in designing similar studies and better understanding the results. If VR goggle technology proves effective, it could contribute to diversifying treatment options for tension-type headache patients and improving access to treatment.

The primary objective of the study is to investigate the effect of virtual reality therapy on pain symptoms in tension-type headache patients. If the results are positive, VR technologies may alleviate pain and enhance the quality of life for these patients. It could also help them function better in their daily lives. If relaxation is found to be effective in the VR group, a new treatment option would be introduced for tension-type headache patients. This could contribute to the diversification of treatment options.

The study poses no risk to the patient. The patient will lie on the bed, and the VR goggles will be used accordingly.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • Çankaya
      • Ankara, Çankaya, Turkey, 06170
        • Ankara Bilkent Şehir Hastanesi

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients between the ages of 18 and 65
  • Patients meeting the criteria for Tension-Type Headache (TTH) in the third edition of the International Classification of Headache Disorders
  • Patients willing to participate in the study
  • Patients indicating a VAS score of 50 and above
  • Patients without other suspected diagnoses
  • Patients with no known history of adverse reactions to the active ingredients of the drugs to be used
  • Conscious patients
  • Patients who are oriented and cooperative

Exclusion Criteria:

  • Patients under the age of 18 and over the age of 65
  • Patients who do not consent to participate in the study
  • Patients with vital signs outside normal limits
  • Patients with a history of adverse reactions to known NSAIDs
  • Individuals unable to determine pain intensity on the VAS
  • Patients with a VAS score of 50 mm and below
  • Pregnant individuals
  • Those with advanced systemic diseases
  • Patients with malignancies
  • Individuals with chronic liver and kidney diseases
  • Those using sedative and analgesic neuro-psychiatric drugs
  • Individuals with a history of psychological and neurological diseases
  • Patients who used analgesics within 8 hours before the examination

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Standart Group
Participants will be selected from patients diagnosed with tension-type headache according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria. All selected participants will be administered 25 mg of dexketoprofen.
Experimental: Virtual Reality
Participants will be selected from patients diagnosed with tension-type headache according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria. Selected participants, in addition to being administered 25 mg of dexketoprofen, will also use virtual reality goggles.
Device: Virtual Reality
Participants will be selected from patients diagnosed with tension-type headache according to the International Classification of Headache Disorders, third edition (ICHD-3) criteria. Selected participants, in addition to being administered 25 mg of dexketoprofen, will also use virtual reality goggles.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reduction in Pain Intensity Measured by Visual Analog Skala (VAS)
Time Frame: Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.
Change in pain intensity was assessed using the Visual Analog Scale (VAS), where participants rated their pain on a scale from 0 mm (no pain) to 100 mm (worst pain ever experienced). The primary outcome was the change in VAS scores from baseline (VAS-0) to subsequent time points (VAS-30, VAS-60, and VAS-120), calculated as ΔVAS and ΔVAS% for each interval.
Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Mood Improvement Measured by Likert Scale
Time Frame: Baseline to the 120th minute post-treatment.
Participants' mood was assessed using a 5-point Likert scale, ranging from 1 (Very Poor) to 5 (Very Good). Mood scores were evaluated at baseline (Likert-0) and at the 120th minute (Likert-120), with the difference used to determine changes in mood.
Baseline to the 120th minute post-treatment.
Occurrence of Side Effects
Time Frame: From baseline to the 120th minute post-treatment.
Side effects, including dizziness, nausea, or other symptoms, were recorded through patient self-reports and observations by research staff at the 30th, 60th, and 120th minutes.
From baseline to the 120th minute post-treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara City Hospital Bilkent

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: SAFA DÖNMEZ, M.D., Ankara City Hospital Bilkent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 30, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Virtual Reality Tension Type

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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