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

S

Saint Clare's Health System

Status

Unknown

Conditions

Hip or Knee Replacement

Treatments

Other: 'M'-Technique®
Other: Standard of Care
Other: Guided Imagery

Study type

Interventional

Funder types

Other

Identifiers

NCT01874379
WIRB #: 20121832 (Other Identifier)
M•TIJRP

Details and patient eligibility

About

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.

Enrollment

225 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

225 participants in 3 patient groups

Guided Imagery
Experimental group
Description:
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.
Treatment:
Other: Guided Imagery
Standard of Care
Active Comparator group
Description:
This group will serve as the control arm
Treatment:
Other: Standard of Care
'M'-Technique®
Experimental group
Description:
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.
Treatment:
Other: 'M'-Technique®

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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