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Completed

NCT Number: NCT06155669

The Use of Virtual Reality Applications in Tension-Type Headaches

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.

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Key information

Conditions

Headache Agnosia Analgesia Brain Diseases Central Nervous System Diseases Headache Disorders Headache Disorders, Primary Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms Tension-Type Headache

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, 06170, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 4, 2023
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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