- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01553578
Healing Touch or Guided Imagery In Treating Pain, Fatigue, Nausea, and Anxiety in Patients Undergoing Chemotherapy
The Efficacy of Healing Touch Versus Guided Imagery on Pain, Fatigue, Nausea, and Anxiety in Patients' Receiving Outpatient Chemotherapy
Study Overview
Status
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
North Carolina
-
Winston-Salem, North Carolina, United States, 27157
- Comprehensive Cancer Center of Wake Forest University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
Ancillary studies
Receive healing touch therapy
Other Names:
Receive healing touch therapy
Other Names:
Receive guided imagery audiotapes
Other Names:
|
Experimental: Arm B (guided imagery)
Patients listen to guided imagery audiotapes for 30 minutes.
|
Ancillary studies
Receive healing touch therapy
Other Names:
Receive guided imagery audiotapes
Other Names:
|
Active Comparator: Arm C (standard care)
Patients receive standard of care.
|
Ancillary studies
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
Collaborators
Investigators
- Principal Investigator: Lisa Hodges, Wake Forest University Health Sciences
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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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