Guided Imagery Response in Total Knee Replacement
Factors Affecting Guided Imagery Response in Total Knee Replacement
1 other identifier
interventional
82
1 country
1
Brief Summary
The purpose of this mixed methods pilot study is to produce preliminary data for a randomized, placebo-controlled trial testing a biobehavioral model of the effects of guided imagery on outcomes of total knee replacement surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
October 4, 2011
CompletedFirst Posted
Study publicly available on registry
December 14, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 6, 2014
January 1, 2014
2.5 years
October 4, 2011
January 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
function
WOMAC AND SF-36
6 months
Study Arms (2)
GUIDED IMAGERY
EXPERIMENTALAUDIO BOOK
PLACEBO COMPARATORInterventions
DAILY LISTENING TO A GUIDED IMAGERY CD FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY
DAILY LISTENING TO AN AUDIO BOOK SEGMENT FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY
Eligibility Criteria
You may qualify if:
- scheduled for a single TKR
- attendance at the hospital joint replacement class
- ability to speak, read, and write English -
You may not qualify if:
- current or planned use of guided imagery
- history of previous total joint replacement
- current enrollment in another clinical studY
- current treatment in a pain management program
- current diagnosis of immune disorders (e.g., rheumatoid arthritis, organ transplant, cancer, HIV, SLE)
- use of immune altering medications in past month
- comorbidities that would limit participation in study procedures or postoperative rehabilitation and/or impair recovery (e.g., psychosis; sensory, cognitive, neurologic or motor impairment
- vision or hearing deficits
- lymphedema
- morbid obesity \[BMI \> 40\])
- reported diagnosis of anemia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Crystal Clinic Orthopaedic Center
Akron, Ohio, 44310, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ANN F JACOBSON, PHD
Kent State University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, College of Nursing
Study Record Dates
First Submitted
October 4, 2011
First Posted
December 14, 2011
Study Start
June 1, 2011
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
January 6, 2014
Record last verified: 2014-01