Guided Imagery Response in Total Knee Replacement

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
ANN F JACOBSON, Kent State University
ClinicalTrials.gov Identifier:
NCT01491750
First received: October 4, 2011
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Osteoarthritis
Behavioral: GUIDED IMAGERY
Behavioral: PLACEBO
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Factors Affecting Guided Imagery Response in Total Knee Replacement

Resource links provided by NLM:


Further study details as provided by Kent State University:

Primary Outcome Measures:
  • function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    WOMAC AND SF-36


Estimated Enrollment: 82
Study Start Date: June 2011
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GUIDED IMAGERY Behavioral: GUIDED IMAGERY
DAILY LISTENING TO A GUIDED IMAGERY CD FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY
Placebo Comparator: AUDIO BOOK Behavioral: PLACEBO
DAILY LISTENING TO AN AUDIO BOOK SEGMENT FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY

Detailed Description:

The study uses a mixed-method design (quantitative experimental pilot study with qualitative descriptive and multiple case study methods) to address the study aims:

AIM 1: Generate estimates of effect sizes and assess feasibility of procedures for a future RCT testing a model of a standardized, prerecorded guided imagery intervention on functional outcomes of TKR.

AIM 2: Elucidate the GI responder mechanism through analysis of the effect of imaging ability and other potential moderators on guided imagery's effects on TKR outcomes.

AIM 3: Analyze the effect of guided imagery on outcome expectancy, psychological distress, rehabilitation commitment and neuroimmune activation as mediators on TKR functional outcomes.

AIM 4: Identify patients' perspectives related to receiving, and participating in a study of, guided imagery intervention for total knee replacement surgery (TKR).

DESIGN The proposed study is a modified sequential explanatory mixed methods design consisting of a Phase I RCT combined with a Phase II qualitative descriptive and case study. Mixed-methods research is an ideal strategy for rigorous development of interventions such as GI for further clinical testing. By systematically combining quantitative and qualitative approaches, the method is uniquely able to produce information for evaluating an intervention's context, its interactions with participant characteristics, and the link between the intervention and the outcomes. A variety of mixed methods designs have been developed, each with a different emphasis on (denoted as UPPER CASE LETTERS), and sequence of (denoted as order of listing), qualitative (qual) and quantitative (quan) approaches. The sequential explanatory design (QUAN/qual), which is primarily quantitatively oriented, uses qualitative methods to further describe and explain within- and between-subject variation on quantitative outcomes in experimental studies.

After the initial quantitative (QUAN) data collection and analysis, criterion sampling will be used to identify average and extreme cases on values of the quantitative outcome variables in treatment groups. Qualitative (qual) data collection and analysis of these cases can provide additional information about the application, operation, and outcome of the intervention beyond statistical findings, and test the validity of conceptual links between the intervention and outcome. Qualitative methods permit fuller exploration of subjective processes as they evolve during a major health care experience and uncover the complex and dynamic nature of these processes, and are particularly suited for gaining description and insight regarding responses to alternative therapies. The sequential explanatory method is thus well-suited for a study of the effects of a CAM intervention. The mixed method design also helps to clarify participants' views of the actual nature of an intervention, including the burden of treatment, and to reveal unanticipated situational constraints and enhancements to its execution.

METHODS In accord with the sequential explanatory design, the project will involve three phases: Phase I (QUAN): Quantitative data collection and analysis; Phase II (qual): Qualitative inquiry to amplify the quantitative findings; and Phase III: Final integration of findings to address the study aims and inform development of a subsequent RCT.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • scheduled for a single TKR
  • attendance at the hospital joint replacement class
  • ability to speak, read, and write English -

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01491750

Locations
United States, Ohio
Crystal Clinic Orthopaedic Center
Akron, Ohio, United States, 44310
Sponsors and Collaborators
Kent State University
Investigators
Principal Investigator: ANN F JACOBSON, PHD Kent State University
  More Information

No publications provided

Responsible Party: ANN F JACOBSON, Professor, College of Nursing, Kent State University
ClinicalTrials.gov Identifier: NCT01491750     History of Changes
Other Study ID Numbers: R21 AT003913-01A2, R21AT003913-01A2
Study First Received: October 4, 2011
Last Updated: January 2, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Kent State University:
SURGERY
TOTAL JOINT REPLACEMENT
TOTAL KNEE REPLACEMENT
GUIDED IMAGERY
COMPLEMENTARY AND ALTERNATIVE THERAPY

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on September 29, 2014