The Use of Virtual Reality Applications in Tension-Type Headaches

NCT ID: NCT06155669

Last Updated: 2025-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-15

Study Completion Date

2024-12-31

Brief Summary

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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

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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.

Conditions

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Headache Analgesia Tension-Type Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Virtual Reality

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ankara City Hospital Bilkent

OTHER

Sponsor Role lead

Responsible Party

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Safa Dönmez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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SAFA DÖNMEZ, M.D.

Role: STUDY_DIRECTOR

Ankara City Hospital Bilkent

Locations

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Ankara Bilkent Şehir Hastanesi

Ankara, Çankaya, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 33767185 (View on PubMed)

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.

Reference Type RESULT
PMID: 35414614 (View on PubMed)

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.

Reference Type RESULT
PMID: 37408348 (View on PubMed)

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.

Reference Type RESULT
PMID: 18187725 (View on PubMed)

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.

Reference Type RESULT
PMID: 19272275 (View on PubMed)

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.

Reference Type RESULT
PMID: 30704678 (View on PubMed)

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.

Reference Type RESULT
PMID: 32359776 (View on PubMed)

Other Identifiers

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Virtual Reality Tension Type

Identifier Type: -

Identifier Source: org_study_id

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