The Use of Virtual Reality Applications in Tension-Type Headaches

NCT06155669 | Completed DMC

• 1 other identifier: Virtual Reality Tension Type
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Headache; Analgesia; Tension-Type Headache

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain Intensity Measured by Visual Analog Skala (VAS)

  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 Outcomes (2)

• Mood Improvement Measured by Likert Scale

  Baseline to the 120th minute post-treatment.

• Occurrence of Side Effects

  From baseline to the 120th minute post-treatment.

Study Arms (2)

Standart Group

NO INTERVENTION

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.

Virtual Reality

EXPERIMENTAL

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

Interventions

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.

Virtual Reality

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, 06170, Turkey (Türkiye)

Location

Related Publications (7)

• 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.

  PMID: 33767185 BACKGROUND

• 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.2022.43.4.20210921.

  PMID: 35414614 RESULT

• 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(4):63-71. doi: 10.22514/jocpd.2023.036. Epub 2023 Jul 3.

  PMID: 37408348 RESULT

• 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.

  PMID: 18187725 RESULT

• 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.

  PMID: 19272275 RESULT

• 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.

  PMID: 30704678 RESULT

• 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.

  PMID: 32359776 RESULT

MeSH Terms

Conditions

Headache; Agnosia; Tension-Type Headache

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases

Study Officials

• SAFA DÖNMEZ, M.D.

  Ankara City Hospital Bilkent

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 26, 2023
• First Posted: December 4, 2023
• Study Start: December 15, 2023
• Primary Completion: July 30, 2024
• Study Completion: December 31, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)