Virtual Reality - A New Vision on Pain

Chronic Pain Clinical Trial

— VROP  

Official title:

Virtual Reality - A New Vision on Pain

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06045741
• Other study ID #: 21/00032
• Status: Active, not recruiting
• Start date: September 1, 2023
• Est. completion date: June 5, 2024

Study information

• Verified date: April 2024
• Source: Sykehuset i Vestfold HF
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of the project is to investigate if the use of virtual reality (VR) technology with pre-programmed proprietary software can provide better treatment for patients with long-term pain conditions. This is investigated in this pilot study conducted on patients referred to outpatient treatment at the Division of Physical Medicine and Rehabilitation. The pilot study will lay the foundation for a follow-up study (RCT). The effect of VR are evaluated by patient reporting forms; before start-up and 3 months after startup. Patients included in the study receive standard treatment supplemented with the use of VR technology.

The therapists involved will be Interviewed to examine their experiences with the use of the VR-technology in the treatment of patients.

VR technology can potentially contribute to better treatment (e.g. measured in outcomes such as activity, sleep problems, pain intensity, quality of life). Moreover we expect that a VR-assisted treatment to be more cost-effective and increased availability regardless of geography and demography.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 33
• Est. completion date: June 5, 2024
• Est. primary completion date: April 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pain duration > 3 moths

• Master Norwegian spoken language

Exclusion Criteria:

• History of malignant disease

• pain duration < 3 Months

• Does not master Norwegian spoken language

• Epilepsy

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Musculoskeletal Diseases
• Musculoskeletal Diseases or Conditions
• Musculoskeletal Disorder
• Musculoskeletal Neck Pain
• Musculoskeletal Pain
• Neck Pain
• Pain, Chronic

Locations

Country	Name	City	State
Norway	Klinikk fysikalsk medisin og rehabilitering, Sykehuset i Vestfold	Tønsberg

Sponsors (1)

Lead Sponsor	Collaborator
Sykehuset i Vestfold HF

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PROMIS Pain interference	Consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities.; PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Primary	PROMIS Pain intensity	Numeric rating scale (NRS (0-10)) How much a person hurts	Three months
Secondary	System Usability Scale (SUS)	The System Usability Scale (SUS) provides a reliable tool for measuring the usability. It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree.	Three months
Secondary	EQ-5D-5L	Health related quality of life; The Health Utilities Index is a rating scale used to measure general health status and health-related quality of life.; Range fra	Three months
Secondary	PROMIS Physical Function	Self-reported capability rather than actual performance of physical activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	PROMIS Emotional Distress - Anxiety	Fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart,dizziness).; PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	PROMIS Emotional Distress - Depression	Negative mood (sadness, guilt), views of self (self- criticism,worthlessness), and social cognition (loneliness, interpersonal alienation), as well as decreased positive affect and engagement (loss of interest, meaning, and purpose).; PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	PROMIS Physical Health - Sleep Disturbance	Perceptions of sleep quality, sleep depth, and restoration associated with sleep.; PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	PROMIS Social Health - Ability to Participate in Social Roles and Activities	Perceived ability to perform one's usual social roles and activities. PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	PROMIS Physical Health - Fatigue	Range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles.; PROMIS measures are scored on the T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population.	Three months
Secondary	RTWSE-11 Return ti work self efficacy	The return to work self efficacy (RTW-SE) score quantifies an individual's confidence in their ability to work fully and perform work tasks while suffering from chronic pain conditions.; The score ranges between 1 and 6, higher scores are better.; Threshold values identified in Norwegian samples: Scores from 3.7 and lower are considered low and are associated with a lower probability of return to work. Scores from 4.6 and above are considered to be high and are associated with a higher probability of return to work.	Three months