Clinical trial NCT06155669: The Use of Virtual Reality Applications in Tension-Type Headaches
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Analgesia
Tension-Type Headache
Lead sponsor: Ankara City Hospital Bilkent
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in Pain Intensity Measured by Visual Analog Skala (VAS)
timeFrame: Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.
Secondary outcomes:
measure: Mood Improvement Measured by Likert Scale
timeFrame: Baseline to the 120th minute post-treatment.
measure: Occurrence of Side Effects
timeFrame: From baseline to the 120th minute post-treatment.
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi
state: Çankaya
Study officials:
affiliation: Ankara City Hospital Bilkent
name: SAFA DÖNMEZ, M.D.
role: STUDY_DIRECTOR
References:
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citation: Burch R. Migraine and Tension-Type Headache: Diagnosis and Treatment. Med Clin North Am. 2019 Mar;103(2):215-233. doi: 10.1016/j.mcna.2018.10.003. Epub 2018 Dec 3.
citation: Yavuz E, Gulacti U, Lok U, Turgut K. Intravenous metoclopramide versus dexketoprofen trometamol versus metoclopramide+ dexketoprofen trometamol in acute migraine attack in the emergency department: A randomized double-blind controlled trial. Am J Emerg Med. 2020 Nov;38(11):2254-2258. doi: 10.1016/j.ajem.2020.04.038. Epub 2020 Apr 15.