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

NCT01553578 — Not applicable, Completed, 244 participants, Wake Forest University Health Sciences

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

Registry	NCT01553578
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, supportive care
Enrollment	244 (Actual)
Sponsor	Wake Forest University Health Sciences (Other); collaborators: National Cancer Institute (NCI)
Conditions	Anxiety Disorder, Fatigue, Malignant Neoplasm, Nausea and Vomiting, Pain
Interventions	questionnaire administration, therapeutic touch, management of therapy complications, standard follow-up care (Other, procedure, behavioral)
Dates	start 2012-02-01, primary completion 2013-02-01, completion 2013-02-01, first posted 2012-03-14, last updated 2018-07-05
Locations	1 site in United States

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Arm A (healing touch therapy)	Experimental	Other: questionnaire administration; Procedure: therapeutic touch; Behavioral: management of therapy complications	Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
Arm B (guided imagery)	Experimental	Other: questionnaire administration; Behavioral: management of therapy complications	Patients listen to guided imagery audiotapes for 30 minutes.
Arm C (standard care)	Active comparator	Other: questionnaire administration; Procedure: standard follow-up care	Patients receive standard of care.

questionnaire administration (Other): Ancillary studies
therapeutic touch (Procedure), also known as healing touch: Receive healing touch therapy
management of therapy complications (Behavioral), also known as complications of therapy, management of: Receive healing touch therapy
management of therapy complications (Behavioral), also known as complications of therapy, management of: Receive guided imagery audiotapes
standard follow-up care (Procedure): Receive standard care

+Outcome measures

Primary outcomes

Change scores for each patient on pain scale [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.
Change scores for each patient on fatigue scale [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.
Change scores for each patient on nausea scale [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.
Change scores for each patient on anxiety scale [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.

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

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

+Locations (1)

Facility	City	Country	Status
Comprehensive Cancer Center of Wake Forest University	Winston-Salem, North Carolina	United States

+Investigators

Lisa Hodges, Principal investigator, Wake Forest University Health Sciences