Recruiting

'M'-Technique, Guided Imagery, Standard of Care

Sponsor:

Saint Clare's Health System

Code:

NCT01874379

Conditions

Hip or Knee Replacement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

'M'-Technique®

Guided Imagery

Standard of Care

Study Details

Brief 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

Study ID

NCT01874379

Start date

Dec, 2012

Status verified date

Jun, 2013

Primary completion date

Jun, 2014

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

225 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Standard of Care

This group will serve as the control arm

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.

Interventions

'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.

Guided Imagery

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

Standard of Care

Normal Procedures, no complementary medicine intervention.

Primary outcome measure

  • Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain [ Time Frame: 18 months ]
  • Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety [ Time Frame: 18 months ]
  • Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2 [ Time Frame: 18 Months ]

Central Contacts and Locations

Locations

Saint Clare's Health System

Recruiting

Denville, New Jersey, United States, 07834

Contacts

Serena A Schmitz, BS, CCRC

973-625-6377serenaschmitz@saintclares.org

Principal Investigator:

J. Brent Forward, MD, FACP

More Information

Sponsor

Saint Clare's Health System

Last update posted

Jun 11, 2013

Last verified

Jun, 2013

Keywords

  • Joint Replacement
  • Hip Replacement
  • Knee Replacement
  • Complementary Medicine Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Saint Clare's Health System on 2013-06-11.