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

NCT01874379 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2013-06-11

No results posted yet for this study

Summary

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.

Conditions

  • Hip or Knee Replacement

Interventions

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

Guided Imagery

Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.

OTHER

Standard of Care

Normal Procedures, no complementary medicine intervention.

Sponsors & Collaborators

  • Saint Clare's Foundation

    collaborator UNKNOWN

  • Saint Clare's Health System

    lead OTHER

Principal Investigators

  • J. Brent Forward, MD, FACP · Saint Clare's Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01874379 on ClinicalTrials.gov