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CompletedNCT06155669Updated Jan 15, 2025

The Use of Virtual Reality Applications in Tension-Type Headaches

An interventional study of Virtual Reality in Headache, Analgesia and Tension-Type Headache, sponsored by Ankara City Hospital Bilkent. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-01-15.

Sponsored by Ankara City Hospital Bilkent · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Headache
  • Analgesia
  • Tension-Type Headache
03

In context

Tension-Type Headache

144 studies on the registry are indexed under Tension-Type Headache; 41 are open to participants now.

This study's enrollment of 140 is above the median of 60 across 109 interventional studies indexed under Tension-Type Headache.

Browse Tension-Type Headache studies →

Lead sponsor

Ankara City Hospital Bilkent is the lead sponsor of 424 studies on the registry; 105 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
140 participants (actual)

Study arms

  • 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

Interventions

  • DeviceVirtual 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.

06

What researchers measure

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.

    Time frame: Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.

Secondary outcomes

  1. Mood Improvement Measured by Likert Scale

    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.

    Time frame: Baseline to the 120th minute post-treatment.

  2. Occurrence of Side Effects

    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.

    Time frame: From baseline to the 120th minute post-treatment.

07

Study locations

1 site
  • Ankara Bilkent Şehir Hastanesi
    Ankara, Çankaya 06170, Turkey
08

References and documents

Publications

  • 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. PubMed 33767185 ↗
  • 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. PubMed 35414614 ↗
  • 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. PubMed 37408348 ↗
  • 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. PubMed 18187725 ↗
  • 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. PubMed 19272275 ↗
  • 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. PubMed 30704678 ↗
  • 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. PubMed 32359776 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06155669
Lead sponsor
Ankara City Hospital Bilkent
Responsible party
Safa Dönmez (Principal Investigator, Ankara City Hospital Bilkent) — Principal investigator
First posted
Dec 4, 2023
Start date
Dec 15, 2023
Primary completion
Jul 30, 2024
Completion
Dec 31, 2024
Last update
Jan 15, 2025

Study contacts

SAFA DÖNMEZ, M.D.
study director · Ankara City Hospital Bilkent

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.

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