Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy

July 2, 2018 updated by: Wake Forest University Health Sciences

The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy

This randomized clinical trial studies healing touch or guided imagery in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy. Healing touch and guided imagery may help treat complications caused by chemotherapy. It is not yet known whether healing touch or guided imagery is more effective in treating pain, fatigue, nausea, and anxiety in patients undergoing chemotherapy

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if the provision of healing touch or guided imagery during outpatient chemotherapy is associated with decreased pain, fatigue, nausea and anxiety when compared to standard outpatient treatment protocols.

OUTLINE: Patients are randomized to 1 of 3 treatment arms.

ARM A: Patients receive 30 minutes of healing touch therapy comprising magnetic clearing, pain drains, hands in motion/hands still and mind clearing.

ARM B: Patients listen to guided imagery audiotapes for 30 minutes

ARM C: Patients receive standard of care.

Study Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

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
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Comprehensive Cancer Center of Wake Forest University

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:

  • Adult patients at the outpatient chemotherapy area will be enrolled without consideration for type of cancer or chemotherapeutic agents to be used

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A (healing touch therapy)
Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
Other: questionnaire administration
Ancillary studies
Procedure: therapeutic touch
Receive healing touch therapy
Other Names:
  • healing touch
Behavioral: management of therapy complications
Receive healing touch therapy
Other Names:
  • complications of therapy, management of
Behavioral: management of therapy complications
Receive guided imagery audiotapes
Other Names:
  • complications of therapy, management of
Experimental: Arm B (guided imagery)
Patients listen to guided imagery audiotapes for 30 minutes.
Other: questionnaire administration
Ancillary studies
Behavioral: management of therapy complications
Receive healing touch therapy
Other Names:
  • complications of therapy, management of
Behavioral: management of therapy complications
Receive guided imagery audiotapes
Other Names:
  • complications of therapy, management of
Active Comparator: Arm C (standard care)
Patients receive standard of care.
Other: questionnaire administration
Ancillary studies
Procedure: standard follow-up care
Receive standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change scores for each patient on pain scale
Time Frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Approximately 6 months
Change scores for each patient on fatigue scale
Time Frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Approximately 6 months
Change scores for each patient on nausea scale
Time Frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Approximately 6 months
Change scores for each patient on anxiety scale
Time Frame: Approximately 6 months
Collected using a 10 point visual analog scale for pain, fatigue, nausea, and anxiety. Analyzed initially using descriptive statistics. Compared among the 3 groups using one-way analysis of variance (ANOVA) models and 2-sample t-tests.
Approximately 6 months

Collaborators and Investigators

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

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Lisa Hodges, Wake Forest University Health Sciences

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

February 1, 2012

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

March 9, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Actual)

July 5, 2018

Last Update Submitted That Met QC Criteria

July 2, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00018805
  • NCI-2012-00164 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • CCCWFU 97511 (Other Identifier: Wake Forest University Health Sciences)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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