Brief Summary

The goal of this pilot randomized clinical trial is to test the efficacy of an intervention combining virtual reality and hypnosis on decreasing pain and improving quality of life in elderly patients with hand arthritis. The main questions it aims to answer are:

Does the intervention allow for an improvement of patient reported outcomes related to pain and quality of life?
Does the intervention allow for an improvement of physiological variables related to pain? Researchers will compare intervention group to a passive control group (i.e., waiting list with treatment as usual). Participants in the intervention group will be provided a virtual reality headset allowing them to beneficiate from the virtual reality and hypnosis modules.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status

not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

5 months study duration

First Submitted

Initial submission to the registry

January 13, 2025

Completed

1 month until next milestone

First Posted

Study publicly available on registry

February 19, 2025

Completed

1 month until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed

5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed

Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

January 13, 2025

Last Update Submit

March 17, 2025

Conditions

Arthritis Arthritis/Arthrosis Arthritis, Rheumatoid Elderly

Keywords

virtual realityhypnosisarthritispainquality of lifeelderly

Outcome Measures

Primary Outcomes (1)

Perceived pain
Brief Pain Inventory - Short Form (BPI-SF) ; 9 items ; Scores from 0 to 10 ; scores are computed into mean score ; higher scores mean higher levels of pain (negative outcome)
Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up

Secondary Outcomes (6)

Anxiodepressive symptoms
Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up
Quality of life
Intervention group: Two times per week (before and after each session)/Control group: One time per week, For all: from enrollment to the end of intervention at 6 weeks and at a 3 weeks follow-up
Fatigue
From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Relaxation
From enrollment, each week during 6 weeks, Intervention group: Two times per week (before and after each session)
Perceived changes
From Session 2, each week during 5 weeks, Intervention group: Two times per week (before and after each session)
+1 more secondary outcomes

Other Outcomes (12)

Respiratory frequence
One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)
Heart rate
One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)
Electrodermal activity
One time per week, from enrollment to the end of treatment at 6 weeks, during the whole hypnosis session (for Intervention group) or during 15 minutes where the subject is not engaging in any task (for Control group)
+9 more other outcomes

Study Arms (2)

Combined virtual reality and hypnosis

EXPERIMENTAL

The intervention consist in 4 different sessions with the VR headset, two consisting in presenting landscapes (i.e., beach, forest) and two consisting in hypnosis techniques (i.e., magic hand, manipulating hand).

Behavioral: Virtual reality: BeachBehavioral: Virtual Reality: ForestBehavioral: Hypnosis: Magic HandBehavioral: Hypnosis: Pain ManipulationBehavioral: Session 1bis - 1 weekBehavioral: Follow-up

Waiting list

NO INTERVENTION

The control group consist in a waiting list.