Guided Imagery Response in Total Knee Replacement

January 2, 2014 updated by: ANN F JACOBSON, Kent State University

Factors Affecting Guided Imagery Response in Total Knee Replacement

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

82

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Akron, Ohio, United States, 44310
        • Crystal Clinic Orthopaedic Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
function
Time Frame: 6 months
WOMAC AND SF-36
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kent State University

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: ANN F JACOBSON, PHD, Kent State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

October 4, 2011

First Submitted That Met QC Criteria

December 12, 2011

First Posted (Estimate)

December 14, 2011

Study Record Updates

Last Update Posted (Estimate)

January 6, 2014

Last Update Submitted That Met QC Criteria

January 2, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R21AT003913-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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