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

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

In the M-TIJRP protocol the investigators will utilize two Integrative Medicine modalities in a randomized, controlled study using either the 'M'-Technique® developed by Jane Buckle, PhD or Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ with nature sounds to determine their effects on a specific group of pre- and post-operative patients, compared to no integrative medicine intervention - considered Standard of Care. A total of 225 patients undergoing surgical hip or knee replacement will participate; one third of the patient population will receive the 'M'-Technique touch intervention, one third will receive Tusek's Guided Imagery intervention delivered by headsets monitored by therapists from our Center for Complementary Medicine (CCM) and one third will comprise the control group, consisting of routine preoperative & postoperative care without integrated intervention.

Patients will be asked to complete Pain and Anxiety scales at four different timepoints throughout their hospital stay. These will occur at Same Day Surgery (pre-operatively), and Post Operatively Day 0, Day 1 & Day 2.

Rationale: Patients are often at their most vulnerable just prior to surgery when their stress and anticipation are high and again immediately afterward when their energy is lower and their bodies are trying to accommodate after an invasive procedure. In addition, the patient and his or her family sense a lack of control and feel a rise in anxiety over the possible outcomes. This stress, anxiety, and pain associated with surgery and recovery can increase complication rates and slow recovery times resulting in longer hospital stays.

Study Overview

• Status: Unknown
• Conditions: Hip or Knee Replacement
• Intervention / Treatment: Other: Guided Imagery; Other: Standard of Care; Other: 'M'-Technique®

• Study Type: Interventional
• Enrollment (Anticipated): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Denville, New Jersey, United States, 07834
      • Recruiting
      • Saint Clare's Health System
      • Contact: Serena A Schmitz, BS, CCRC; Phone Number: 973-625-6377; Email: serenaschmitz@saintclares.org
      • Principal Investigator: J. Brent Forward, MD, FACP
      • Sub-Investigator: Nancy Greuter, RN, NCTMB

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age > 18 years old
2. Be receiving an initial or subsequent elective hip or knee replacement surgery

Exclusion Criteria:

1. Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
2. Patients with touch aversion
3. Non-English speaking patients - due to guided imagery recording availability in English only
4. Patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation
5. Patients who lack the sensation of being touched on the hands and/or feet

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Imagery; 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.	Other: Guided Imagery; Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.
Active Comparator: Standard of Care; This group will serve as the control arm	Other: Standard of Care; Normal Procedures, no complementary medicine intervention.; Other Names: Control; No Intervention
Experimental: 'M'-Technique®; 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.	Other: 'M'-Technique®; 'M'-Technique is a series of gentle stroking movements performed in a set sequence, with a set pressure of 3 on a scale of 0-10.; Other Names: Light Structured Touch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain	Measurement with Visual Analogue Scale	18 months
Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety	Visual Analogue Scale	18 months
Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2		18 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Satisfaction Measure	Protocol specific questionnaire	18 months

Collaborators and Investigators

• Sponsor: Saint Clare's Health System
• Collaborators: Saint Clare's Foundation
• Investigators: Principal Investigator: J. Brent Forward, MD, FACP, Saint Clare's Health System

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Anticipated): June 1, 2014
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: June 6, 2013
• First Posted (Estimate): June 11, 2013

Study Record Updates

• Last Update Posted (Estimate): June 11, 2013
• Last Update Submitted That Met QC Criteria: June 6, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Hip Replacement; Knee Replacement; Joint Replacement; Complementary Medicine Intervention
• Other Study ID Numbers: M•TIJRP; WIRB #: 20121832 (Other Identifier: Western Institutional Review Board)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No