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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

M•TIJRP Trial 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.Check my eligibility

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.See study design

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.

M•TIJRP Trial 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.

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I am older than 18 years.

M•TIJRP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2

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 outcome measures

Patient Satisfaction Measure

M•TIJRP 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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still open for this investigation?

"This investigation, which was originally posted on December 1st 2012 and revised most recently on June 6th 2013, is not currently looking to enrol patients. Nonetheless, there are other clinical trials in the same field that require volunteers at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients

2012. "'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01874379.

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