Clinical trial NCT01874379: 'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients
Official title: 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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip or Knee Replacement
Keywords: Joint Replacement
Hip Replacement
Knee Replacement
Complementary Medicine Intervention
Lead sponsor: Saint Clare's Health System
Sponsor class: OTHER
Collaborators: name: Saint Clare's Foundation
First posted: 2013-06-11
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain
timeFrame: 18 months
measure: Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety
timeFrame: 18 months
measure: Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2
timeFrame: 18 Months
Secondary outcomes:
measure: Patient Satisfaction Measure
timeFrame: 18 months
Other outcomes:
Locations:
city: Denville
country: United States
facility: Saint Clare's Health System
state: New Jersey
Study officials:
affiliation: Saint Clare's Health System
name: J. Brent Forward, MD, FACP
role: PRINCIPAL_INVESTIGATOR
References: