## Protocol Section
### Identification Module
**NCT ID:** NCT01874379

**Acronym:** M•TIJRP

**Brief Title:** '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.

#### Organization Study ID Info
**ID:** M•TIJRP
#### Organization
**Class:** OTHER
**Full Name:** Saint Clare's Health System
#### Secondary ID Infos
**Domain:** Western Institutional Review Board
**ID:** WIRB #: 20121832
**Type:** OTHER
### Status Module
#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2013-06-11

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-06-06

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2014-06

**Type:** ESTIMATED

#### Start Date
**Date:** 2012-12

**Status Verified Date:** 2013-06

#### Study First Post Date
**Date:** 2013-06-11
**Type:** ESTIMATED
**Study First Submit Date:** 2013-04-22
**Study First Submit QC Date:** 2013-06-06
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Saint Clare's Foundation

#### Lead Sponsor

**Class:** OTHER

**Name:** Saint Clare's Health System

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Hip or Knee Replacement

**Keywords:**

- Joint Replacement

- Hip Replacement

- Knee Replacement

- Complementary Medicine Intervention

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 225

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**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.

**Intervention Names:**

- Other: Guided Imagery

**Label:** Guided Imagery

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** This group will serve as the control arm

**Intervention Names:**

- Other: Standard of Care

**Label:** Standard of Care

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**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.

**Intervention Names:**

- Other: 'M'-Technique®

**Label:** 'M'-Technique®

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 'M'-Technique®

**Description:** '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.

**Name:** 'M'-Technique®

**Other Names:**

- Light Structured Touch

**Type:** OTHER

#### Intervention 2

**Arm Group Labels:**

- Guided Imagery

**Description:** Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.

**Name:** Guided Imagery

**Type:** OTHER

#### Intervention 3

**Arm Group Labels:**

- Standard of Care

**Description:** Normal Procedures, no complementary medicine intervention.

**Name:** Standard of Care

**Other Names:**

- Control

- No Intervention

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** Measurement with Visual Analogue Scale

**Measure:** Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain

**Time Frame:** 18 months

**Description:** Visual Analogue Scale

**Measure:** Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety

**Time Frame:** 18 months

**Measure:** Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2

**Time Frame:** 18 Months

#### Secondary Outcomes

**Description:** Protocol specific questionnaire

**Measure:** Patient Satisfaction Measure

**Time Frame:** 18 months

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Denville

**Contacts:**

***Contact 1:***

- **Email:** serenaschmitz@saintclares.org

- **Name:** Serena A Schmitz, BS, CCRC

- **Phone:** 973-625-6377

- **Role:** CONTACT

***Contact 2:***

- **Name:** J. Brent Forward, MD, FACP

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Nancy Greuter, RN, NCTMB

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Saint Clare's Health System

**State:** New Jersey

**Status:** RECRUITING

**Zip:** 07834

#### Overall Officials

**Official 1:**

**Affiliation:** Saint Clare's Health System

**Name:** J. Brent Forward, MD, FACP

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Browse Branches

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M19653

- Name: Cyproterone Acetate

- Relevance: LOW

- As Found: Unknown

- ID: M6739

- Name: Cyproterone

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
