The Use of Virtual Reality Applications in Tension-Type Headaches

Sponsor
Ankara City Hospital Bilkent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06155669
Collaborator
(none)
100
1
2
13.5
7.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Virtual Reality
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Dec 15, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Jan 30, 2025

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  1. Visual Analog Scale (VAS) [15. -30.-60.-120. minutes]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ankara Bilkent Şehir Hastanesi Ankara Çankaya Turkey 06170

Sponsors and Collaborators

  • Ankara City Hospital Bilkent

Investigators

  • Study Director: SAFA DÖNMEZ, M.D., Ankara Bilkent City Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Safa Dönmez, M.D., Ankara City Hospital Bilkent
ClinicalTrials.gov Identifier:
NCT06155669
Other Study ID Numbers:
  • Virtual Reality Tension Type
First Posted:
Dec 4, 2023
Last Update Posted:
Dec 4, 2023
Last Verified:
Nov 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 4, 2023