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HeadacheNCT06155669

The Use of Virtual Reality Applications in Tension-Type Headaches

A study testing Virtual Reality in people with Headache and Analgesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Headache, Analgesia, Tension-Type Headache
What is being tested?
Virtual Reality
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Dec 2023to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Ankara Bilkent Şehir Hastanesi

    Ankara, Çankaya, 06170

Other trials in Turkey (Türkiye)

About this study

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

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.

Being tested
Virtual Reality
Medical subject headings
Headache, Agnosia, Tension-Type Headache

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Virtual RealityDevice

    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.

Study groups in NCT06155669
Study groupRoleWhat they receive
Standart GroupNo interventionParticipants 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 RealityExperimentalParticipants 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.
Receives: Device: Virtual Reality

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (2)

  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.

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2023
  2. Study start15 Dec 2023
  3. Primary completion30 Jul 2024
  4. Study completion31 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06155669
Sponsor's protocol ID
Virtual Reality Tension Type
Status last verified
Jan 2025
First submitted
26 Nov 2023
Last updated
15 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Virtual Reality in people with Headache and Analgesia, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction in Pain Intensity Measured by Visual Analog Skala (VAS) (time frame: Baseline (VAS-0) to 30th, 60th, and 120th minutes post-treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06155669, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.

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