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NCT01553578 Clinical Trial

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

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01553578
Other study ID # IRB00018805
Secondary ID NCI-2012-00164CC
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date February 2013

Study information
Verified date July 2018
Source Wake Forest University Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 244
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• questionnaire administration
Ancillary studies
Procedure:
• therapeutic touch
Receive healing touch therapy
Behavioral:
• management of therapy complications
Receive healing touch therapy
• management of therapy complications
Receive guided imagery audiotapes
Procedure:
• standard follow-up care
Receive standard care

Locations
Country Name City State
United States Comprehensive Cancer Center of Wake Forest University Winston-Salem North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Wake Forest University Health Sciences National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change scores for each patient on pain scale 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
Primary Change scores for each patient on fatigue scale 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
Primary Change scores for each patient on nausea scale 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
Primary Change scores for each patient on anxiety scale 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
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