The Use of Virtual Reality Applications in Tension-Type Headaches

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06155669
• Other study ID #: Virtual Reality Tension Type
• Status: Recruiting
• Phase: N/A
• Start date: December 15, 2023
• Est. completion date: January 30, 2025

Study information

• Verified date: January 2024
• Source: Ankara City Hospital Bilkent
• Contact: SAFA DÖNMEZ, M.D.
• Phone: +90 553 751 55 45
• Email: drsafa0131[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: January 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients between the ages of 18 and 60
• 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 60
• 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

Related Conditions & MeSH terms

• Analgesia
• Headache
• Migraine
• Tension-Type Headache

Intervention

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.

Locations

Country	Name	City	State
Turkey	Ankara Bilkent Sehir Hastanesi	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ankara City Hospital Bilkent

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

Almedhesh SA, Elgzar WT, Ibrahim HA, Osman HA. The effect of virtual reality on anxiety, stress, and hemodynamic parameters during cesarean section: A randomized controlled clinical trial. Saudi Med J. 2022 Apr;43(4):360-369. doi: 10.15537/smj.2022.43.4.2 — View Citation

Ashina S, Mitsikostas DD, Lee MJ, Yamani N, Wang SJ, Messina R, Ashina H, Buse DC, Pozo-Rosich P, Jensen RH, Diener HC, Lipton RB. Tension-type headache. Nat Rev Dis Primers. 2021 Mar 25;7(1):24. doi: 10.1038/s41572-021-00257-2. — View Citation

Bagher SM, Felemban OM, Alandijani AA, Tashkandi MM, Bhadila GY, Bagher AM. The effect of virtual reality distraction on anxiety level during dental treatment among anxious pediatric patients: a randomized clinical trial. J Clin Pediatr Dent. 2023 Jul;47( — View 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. — View Citation

Loder E, Rizzoli P. Tension-type headache. BMJ. 2008 Jan 12;336(7635):88-92. doi: 10.1136/bmj.39412.705868.AD. No abstract available. — View Citation

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8. — View 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 Me — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scale (VAS)	VAS is a scale used for assessing or expressing a condition, typically involving marking a point on a line, usually of 100 mm in length. 0 mm represents no pain at all, while 100 mm represents the most intense pain.	15. -30.-60.-120. minutes