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Clinical Trials/NCT02194413
NCT02194413
Completed
N/A

Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

University of Iowa1 site in 1 country60 target enrollmentMarch 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Anxiety Disorder
Sponsor
University of Iowa
Enrollment
60
Locations
1
Primary Endpoint
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

This randomized pilot clinical trial studies healing touch or usual care in improving quality of life in patients undergoing stem cell transplant. Healing touch may improve the quality of life of patients undergoing stem cell transplant.

Detailed Description

Primary Objectives: I. To estimate the effects of healing touch (HT) vs usual care in the following clinical outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to engraftment, and number of hospital readmissions during 100 days post-transplant. II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT patients who receive HT vs. usual care. III. To examine differences in effects of HT vs. usual care (UC) in patients receiving related allogeneic (Allo) transplant compared to those receiving autologous (Auto) transplant. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital. ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. After completion of study treatment, patients are followed up for 100 days.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
January 18, 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Susan Lutgendorf

Professor

University of Iowa

Eligibility Criteria

Inclusion Criteria

  • Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell transplantation
  • Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of the University of Iowa Hospitals and Clinic
  • Ability to provide written informed consent obtained prior to participation in the study and able to complete questionnaires
  • Pregnant woman who are eligible for stem cell transplant are included in this study

Exclusion Criteria

  • Patients with any significant history of non-compliance to medical regimens, with inability to grant a reliable informed consent or unable to complete questionnaires
  • Patients with evidence of a significant psychiatric disorder by history that would prevent completion of the study will not be allowed to participate, i.e., schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder
  • Diagnosis of dementia or other disease affecting cognitive function
  • Nursing women are excluded

Outcomes

Primary Outcomes

Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater

Time Frame: Up to 100 days

Changes in QoL (POMS-SF, FACT-BMT, CES-D)

Time Frame: Baseline up to 100 days

Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated.

Secondary Outcomes

  • Number of hospital readmissions(Up to 100 days)

Study Sites (1)

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