Hypnosis Intervention for the Management of Pain Perception During Joint Lavage (HypnoArt)

Assistance Publique - Hôpitaux de Paris

Status and phase: Enrolling; Phase 3

Conditions: Knee Osteoarthritis

Treatments: Other: Hypnosis

Study type: Interventional

Funder types: Other

Identifiers

NCT04547595

2020-A02333-36 (Other Identifier)

APHP200138

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• diagnosis of knee osteoarthritis
• indication for a lavage

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

CONTROL

No Intervention group

Description:

Standard care

Hypnosis

Active Comparator group

Description:

Standard care + intervention

Treatment:

Other: Hypnosis