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'M'-Technique + Guided Imagery for Joint Replacement Surgery Anxiety and Pain (M•TIJRP Trial)

N/A
Waitlist Available
Led By J. Brent Forward, MD, FACP
Research Sponsored by Saint Clare's Health System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be receiving an initial or subsequent elective hip or knee replacement surgery
Age > 18 years old
Must not have
Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights

Summary

This trial will test whether two integrative medicine interventions can help to reduce pain and anxiety in patients before and after surgery, compared to no intervention.

Who is the study for?
This trial is for adults over 18 years old who are about to have or have had elective hip or knee replacement surgery. It's not for those who don't speak English, can't hear well enough to hold a conversation, lack touch sensation in hands/feet, have an active infection/open wound where the 'M'-Technique would be applied, or dislike being touched.
What is being tested?
The study tests two integrative medicine approaches against standard care in patients undergoing hip/knee replacements. One group receives the 'M'-Technique (a type of touch therapy), another gets Guided Imagery with nature sounds through headsets, and a control group gets routine care without these interventions.
What are the potential side effects?
Since this trial involves non-invasive techniques like guided imagery and gentle touch ('M'-Technique), side effects are minimal but could include discomfort from listening to audio or being touched if one has sensitivity issues not previously identified.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am scheduled for a hip or knee replacement surgery.
Select...
I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have an active infection or open wound where the 'M'-Technique would be applied.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain
Secondary study objectives
Patient Satisfaction Measure

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Guided ImageryExperimental Treatment1 Intervention
The therapist will instruct the patient on the Guided Imagery protocol and will provide the patient with headphones and an MP-3 player to use for the guided imagery intervention. The patient will listen to the Guided Imagery for 18min 30 sec.
Group II: 'M'-Technique®Experimental Treatment1 Intervention
The 'M'-Technique will be administered to the patient's hands and feet for a total of 18-20 minutes, to be equally divided between extremities used according to limitations as outlined. Any hand or foot that is accessed by an IV will be avoided.
Group III: Standard of CareActive Control1 Intervention
This group will serve as the control arm

Find a Location

Who is running the clinical trial?

Saint Clare's Health SystemLead Sponsor
Saint Clare's FoundationUNKNOWN
J. Brent Forward, MD, FACPPrincipal InvestigatorSaint Clare's Health System

Media Library

Hip or Knee Replacement Clinical Trial 2023: Guided Imagery Highlights & Side Effects. Trial Name: NCT01874379 — N/A
~18 spots leftby Sep 2025
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