Hip or Knee Replacement Clinical Trial
— M•TIJRPOfficial 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.
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.
| Status | Recruiting |
| Enrollment | 225 |
| Est. completion date | |
| Est. primary completion date | June 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Saint Clare's Health System | Denville | New Jersey |
| Lead Sponsor | Collaborator |
|---|---|
| Saint Clare's Health System | Saint Clare's Foundation |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain | Measurement with Visual Analogue Scale | 18 months | No |
| Primary | Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety | Visual Analogue Scale | 18 months | No |
| Primary | Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2 | 18 Months | No | |
| Secondary | Patient Satisfaction Measure | Protocol specific questionnaire | 18 months | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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