Guided Imagery Response in Total Knee Replacement

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.

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