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

Status unconfirmed · Not applicable

Conditions studied: Hip or Knee Replacement

In brief

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.

Key facts

Study ID

NCT01874379

Run by

Saint Clare's Health System

People needed

225

Starts

2012-12-01

Last updated by the study team

2013-06-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Saint Clare's Health System — Denville, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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