Hip or Knee ReplacementM•TIJRPNCT01874379
'M'-Technique, Guided Imagery, or Standard of Care on Anxiety and Pain Pre- & Post-operatively in Elective Joint Replacement Patients
A study testing 'M'-Technique® and Guided Imagery in people with Hip or Knee Replacement, run by Saint Clare's Health System at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip or Knee Replacement
- What is being tested?
- 'M'-Technique® and Guided Imagery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Be receiving an initial or subsequent elective hip or knee replacement surgery
Who cannot join
- Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
- Patients with touch aversion
- Non-English speaking patients - due to guided imagery recording availability in English only
- Patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation
- Patients who lack the sensation of being touched on the hands and/or feet
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Saint Clare's Health System
Denville, New Jersey, 07834
Serena A Schmitz, BS, CCRC, 973-625-6377, serenaschmitz@saintclares.org
J. Brent Forward, MD, FACP
About this study
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.
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
- Hip or Knee Replacement
- Being tested
- 'M'-Technique®, Guided Imagery, Standard of Care
- Keywords
- Joint Replacement, Hip Replacement, Knee Replacement, Complementary Medicine Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
'M'-Technique®Other
Also called Light Structured Touch
'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.
Guided ImageryOther
Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.
Standard of CareOther
Also called Control, No Intervention
Normal Procedures, no complementary medicine intervention.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Guided Imagery |
| Standard of Care | Active comparator | This group will serve as the control arm Receives: Other: Standard of Care |
| '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. Receives: Other: 'M'-Technique® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain
Measurement with Visual Analogue Scale
Measured: 18 months
Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety
Visual Analogue Scale
Measured: 18 months
Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2
Measured: 18 Months
Secondary outcomes (1)
Patient Satisfaction Measure
Protocol specific questionnaire
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2013 (estimated)
- Study startDec 2012
- Primary completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip or Knee ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 225 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Clare's Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Saint Clare's Foundation
- Responsible party
- Sponsor
- Investigators
- J. Brent Forward, MD, FACP, Principal investigator, Saint Clare's Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01874379
- Sponsor's protocol ID
- M•TIJRP
- Other IDs
- WIRB #: 20121832
- Acronym
- M•TIJRP
- Status last verified
- Jun 2013
- First submitted
- 22 Apr 2013
- Last updated
- 11 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01874379
- Acronym / sponsor ID
- M•TIJRP / M•TIJRP
- Conditions
- Hip or Knee Replacement
- Keywords
- Joint Replacement, Hip Replacement, Knee Replacement, Complementary Medicine Intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 225 participants (estimated)
- Lead sponsor
- Saint Clare's Health SystemUniversity, hospital or other
- Collaborators
- Saint Clare's Foundation
- Study start
- Dec 2012
- Primary completion
- Jun 2014 (estimated)
- First posted
- 11 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Imagery | Experimental | Other: Guided ImageryThe 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. |
| Standard of Care | Active comparator | Other: Standard of CareThis group will serve as the control arm |
| 'M'-Technique® | Experimental | Other: 'M'-Technique®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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age > 18 years old
- Be receiving an initial or subsequent elective hip or knee replacement surgery
Key exclusion criteria (5 listed)
- Patients with an active infection or open wound in the location of the extremities where the 'M'-Technique will be performed
- Patients with touch aversion
- Non-English speaking patients - due to guided imagery recording availability in English only
- Patients who demonstrate insufficient auditory discrimination as determined by their ability to engage in normal conversation
- Patients who lack the sensation of being touched on the hands and/or feet
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 'M'-Technique®Also: Light Structured Touch'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. | Other | 'M'-Technique® |
| Guided ImageryDiane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used. | Other | Guided Imagery |
| Standard of CareAlso: Control, No InterventionNormal Procedures, no complementary medicine intervention. | Other | Standard of Care |
Primary outcome
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain
Time frame: 18 months
Measurement with Visual Analogue Scale
Symptomatic anxiety relief expressed in Visual Analogue Scales from no anxiety 0-10 worst possible anxiety
Time frame: 18 months
Visual Analogue Scale
Change from Baseline in Hamilton Anxiety Scale at Post Op Day 2
Time frame: 18 Months
1 secondary outcome
Patient Satisfaction Measure
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Brent Forward, MD, FACP principal investigator
Saint Clare's Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 'M'-Technique® and Guided Imagery in people with Hip or Knee Replacement, run by Saint Clare's Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic pain relief expressed in Visual Analogue Scales from no pain 0-10 worst possible pain (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2013.