Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
HypnoArt
Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis
2 other identifiers
interventional
100
1 country
1
Brief Summary
The purpose of this study is to determine whether hypnosis intervention added to usual care is more effective than usual care alone to control pain during lavage procedure in patients with knee osteoarthrosis
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 knee-osteoarthritis
Started Oct 2021
Longer than P75 for phase_3 knee-osteoarthritis
1 active site
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
First Submitted
Initial submission to the registry
September 7, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedStudy Start
First participant enrolled
October 6, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2025
CompletedDecember 30, 2024
December 1, 2024
3.5 years
September 7, 2020
December 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain
One Day, at end of lavage procedure
Secondary Outcomes (7)
Anxiety assessed by Visual Analog Scale
Day 1, before lavage procedure
Anxiety assessed by Visual Analog Scale
Day 1, at end of lavage procedure
Pain assessed by Visual Analog Scale
Day 1, before lavage procedure
Pain assessed by Visual Analog Scale
Day 7, after lavage procedure
Gesture tolerability
Day 1, at end of lavage procedure
- +2 more secondary outcomes
Study Arms (2)
CONTROL
NO INTERVENTIONStandard care
Hypnosis
ACTIVE COMPARATORStandard care + intervention
Interventions
Eligibility Criteria
You may qualify if:
- diagnosis of knee osteoarthritis
- indication for a lavage
You may not qualify if:
- People who have had both knees washed on the same day.
- People who have already received a joint lavage.
- Patients with psychotic disorders.
- Refusal to participate.
- People who do not understand and/or speak French or who are deaf.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Cochin Hospital - Rheumatology department
Paris, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anna MOLTO, MD, PhD
APHP
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2020
First Posted
September 14, 2020
Study Start
October 6, 2021
Primary Completion
April 1, 2025
Study Completion
April 1, 2025
Last Updated
December 30, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share