The Effect of Perception of Improvement Provided Virtual Reality Environment on Symptom Presence and Severity in Patients With Fibromyalgia

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Fibromyalgia (FM) is a chronic pain syndrome characterized by impaired perception, transmission, and processing of nociceptive stimuli and causing widespread pain. Pain in FM is the disease itself and is characterized by nociplastic pain that may occur independently of any peripheral nociceptor activity or be felt without disease or damage to the somatosensory system. It is thought that the pain processing process is disrupted due to the changing neurotransmitter release activity and this situation causes pain to be felt more in FM. Chronic pain is the result of perception alteration associated with nociceptive afferent information affecting the cortex; underlying this change are limbic emotional learning mechanisms. Numerous factors, including emotional state, attention, and past painful experiences, modulate nociceptive inputs with the activation of multiple brain regions, resulting in a personalized pain experience. The chronic pain management program should target the central nervous system rather than the peripheral tissues because pain originates in the sensitized nervous system. For this reason, it is important to include plasticity-oriented approaches, cortical disinhibition methods, and strategies for improving perception and behavior change, which aim to replace negative beliefs with positive beliefs, into clinical practice. Our project aims to investigate the effectiveness of the therapeutic intervention, which consists of patient education supported Neuro-Linguistic Programming (NLP), visual feedback and metaphor-assisted breathing therapy designed to provide a perception of improvement and presented in a virtual reality environment, on pain processing, pain intensity, pain-pressure threshold, psychosomatic reflections (biomechanical and viscoelastic properties of tissue, sleep quality, pain catastrophizing behavior, anxiety and depression), disease impact and quality of life in FM patients.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 25
Maximum Age: 55
Healthy Volunteers: f
View:

• Diagnosed with Fibromyalgia at least 1 year ago according to ACR criteria

• Age range 25-55

• Female

• Scored at least 24 on the Mini-Mental State Assessment Test

• Reported weekly pain intensity of at least 40 mm on the Visual Analog Scale

• Be on a stable dose of medication for at least 6 months (serotonin norepinephrine reuptake inhibitors \[e.g., duloxetine, milnacipran\]; alpha 2-delta receptor ligand \[e.g., pregabalin\]; gabapentinoids)

Locations
Other Locations
Turkey
Nilüfer kablan
RECRUITING
Istanbul
Contact Information
Primary
nilüfer Kablan, PhD
niluferkablan@yahoo.com
05067638556
Backup
Tansu Birinci Olgun, PhD
tansubirinci@hotmail.com
0535 272 22 24
Time Frame
Start Date: 2024-08-13
Estimated Completion Date: 2026-08-15
Participants
Target number of participants: 39
Treatments
Active_comparator: Control Group
NLP-supported patient education will be given and breath therapy will be applied to the Control Group
Experimental: Virtual Reality Group-1
NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the three most painful points in the McGill-Melzack Pain Scale (real painful points) were given to this group in virtual reality environment.
Experimental: Virtual Reality Group-2
NLP-supported patient education will be given. Visual feedback and metaphor-assisted breathing therapy over the contralateral of the points reported as the three most painful points in the McGill-Melzack Pain Scale (virtual painful points) to this group in a virtual reality environment
Related Therapeutic Areas
Sponsors
Leads: Istanbul Medeniyet University

This content was sourced from clinicaltrials.gov