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| ID | Type | Description | Link |
|---|---|---|---|
| WIRB #: 20121832 | Other Identifier | Western Institutional Review Board |
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| Name | Class |
|---|---|
| Saint Clare's Foundation | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided Imagery | Experimental | 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. |
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| Standard of Care | Active Comparator | This group will serve as the control arm |
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| 'M'-Technique® | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 'M'-Technique® | Other | '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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain | Measurement with Visual Analogue Scale | 18 months |
| Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety | Visual Analogue Scale | 18 months |
| Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2 | 18 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Measure | Protocol specific questionnaire | 18 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J. Brent Forward, MD, FACP | Saint Clare's Health System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Clare's Health System | Recruiting | Denville | New Jersey | 07834 | United States |
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| Guided Imagery | Other | Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used. |
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| Standard of Care | Other | Normal Procedures, no complementary medicine intervention. |
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| ID | Term |
|---|---|
| D019018 | Imagery, Psychotherapy |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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