Hypnosis Intervention for the Management of Pain Perception During Joint Lavage (HypnoArt)
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
About this trial
This is an interventional prevention trial for Knee Osteoarthritis focused on measuring hypnosis intervention, analgesics, knee osteoarthritis, joint lavage
Eligibility Criteria
Inclusion Criteria:
- diagnosis of knee osteoarthritis
- indication for a lavage
Exclusion Criteria:
- previous knee lavage
- psychiatric diseases (current or past)
- current use of psychotropic drugs
- patient refusal
Sites / Locations
- Cochin Hospital - Rheumatology departmentRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
CONTROL
Hypnosis
Arm Description
Standard care
Standard care + intervention
Outcomes
Primary Outcome Measures
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain
Secondary Outcome Measures
Anxiety assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe anxiety
Anxiety assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe anxiety
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain
Pain assessed by Visual Analog Scale
VAS range 0-10, 10 for most severe pain -via phone call
Gesture tolerability
4 points : Perfectly tolerable / tolerable / with difficulty / untolerable
Analgesics consumption
Quantification
Operator Impact
pain VAS by linear regression, adjusted by the 'operator' variable
Full Information
NCT ID
NCT04547595
First Posted
September 7, 2020
Last Updated
February 22, 2023
Sponsor
Assistance Publique - Hôpitaux de Paris
1. Study Identification
Unique Protocol Identification Number
NCT04547595
Brief Title
Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
Acronym
HypnoArt
Official Title
Assessment of Efficacy of Hypnosis Intervention During Lavage Procedure for Knee Osteoarthrosis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2021 (Actual)
Primary Completion Date
March 2023 (Anticipated)
Study Completion Date
March 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Joint lavage can be used in acute knee osteoarthritis, and can be repeated when it is effective. This procedure can generate pain and anxiety which are prevented by systematic prescription of analgesics and anxiolytics. To assess the benefit of hypnosis intervention, the investigators designed a monocentric prospective controlled randomised, single-blind study. Patients with acute and painful knee osteoarthritis, having an indication of lavage according to the rheumatologist, will be randomized to standard care, versus standard care and hypnosis. The hypothesis is that hypnosis intervention will decrease the level of pain during lavage, and the analgesics consumption during the week following the lavage. The sample size will be 100, 50 patients per group. Inclusion is scheduled for 18 months, and duration of the study will be 2 years. The main efficacy criterion is the pain score (assessed using VAS) difference between the 2groups; no interim analysis will be performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
hypnosis intervention, analgesics, knee osteoarthritis, joint lavage
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CONTROL
Arm Type
No Intervention
Arm Description
Standard care
Arm Title
Hypnosis
Arm Type
Active Comparator
Arm Description
Standard care + intervention
Intervention Type
Other
Intervention Name(s)
Hypnosis
Other Intervention Name(s)
Ericksonienne Method
Intervention Description
given by Expert in this method
Primary Outcome Measure Information:
Title
Pain assessed by Visual Analog Scale
Description
VAS range 0-10, 10 for most severe pain
Time Frame
One Day, at end of lavage procedure
Secondary Outcome Measure Information:
Title
Anxiety assessed by Visual Analog Scale
Description
VAS range 0-10, 10 for most severe anxiety
Time Frame
Day 1, before lavage procedure
Title
Anxiety assessed by Visual Analog Scale
Description
VAS range 0-10, 10 for most severe anxiety
Time Frame
Day 1, at end of lavage procedure
Title
Pain assessed by Visual Analog Scale
Description
VAS range 0-10, 10 for most severe pain
Time Frame
Day 1, before lavage procedure
Title
Pain assessed by Visual Analog Scale
Description
VAS range 0-10, 10 for most severe pain -via phone call
Time Frame
Day 7, after lavage procedure
Title
Gesture tolerability
Description
4 points : Perfectly tolerable / tolerable / with difficulty / untolerable
Time Frame
Day 1, at end of lavage procedure
Title
Analgesics consumption
Description
Quantification
Time Frame
Over 1 week after lavage procedure
Title
Operator Impact
Description
pain VAS by linear regression, adjusted by the 'operator' variable
Time Frame
Over 1 week after lavage procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
diagnosis of knee osteoarthritis
indication for a lavage
Exclusion Criteria:
previous knee lavage
psychotic disorders
current use of psychotropic drugs
patient refusal
who do not understand and/or speak french and hearing impaired
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melissa CREHALET MONNIER, Nurse
Phone
+ 33 1 58 41 86 51
Email
melissa.crealet-monnier@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Guillaume MASSON, MSc
Phone
+33 1 58 41 34 78
Email
guillaume.masson@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna MOLTO, MD, PhD
Organizational Affiliation
APHP
Official's Role
Study Chair
Facility Information:
Facility Name
Cochin Hospital - Rheumatology department
City
Paris
ZIP/Postal Code
75014
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melissa CREHALET MONNIER, Nurse
Phone
+33 1 58 41 86 51
Email
melissa.crehalet-monnier@aphp.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hypnosis Intervention for the Management of Pain Perception During Joint Lavage
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