Hip or Knee Replacement
Conditions
Keywords
Joint Replacement, Hip Replacement, Knee Replacement, Complementary Medicine Intervention
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.
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.
OTHERGuided Imagery
Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.
OTHERStandard of Care
Normal Procedures, no complementary medicine intervention.
Sponsors
Saint Clare's Foundation
Saint Clare's Health System
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain | 18 months | Measurement with Visual Analogue Scale |
| Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety | 18 months | Visual Analogue Scale |
| Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2 | 18 Months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Measure | 18 months | Protocol specific questionnaire |
Countries
United States
Outcome results
None listed