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

Not Applicable

Completed

• Conditions: Anxiety Disorder; Fatigue; Pain; Malignant Neoplasm; Nausea and Vomiting
• Interventions: Other: questionnaire administration; Procedure: therapeutic touch; Behavioral: management of therapy complications; Procedure: standard follow-up care

• Registration Number: NCT01553578
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-03-09
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-02
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A (healing touch therapy)	questionnaire administration	Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
Arm A (healing touch therapy)	therapeutic touch	Patients receive 30 minutes of healing touch therapy consisting of magnetic clearing, pain drains, hands in motion/hands still and mind clearing.
Arm C (standard care)	questionnaire administration	Patients receive standard of care.
Arm B (guided imagery)	management of therapy complications	Patients listen to guided imagery audiotapes for 30 minutes.
Arm A (healing touch therapy)	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)	questionnaire administration	Patients listen to guided imagery audiotapes for 30 minutes.
Arm C (standard care)	standard follow-up care	Patients receive standard of care.

Primary Outcome Measures

Name	Time	Method
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 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.
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 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.

Trial Locations

Locations (1)

Comprehensive Cancer Center of Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States