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Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

Primary Purpose

Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
therapeutic touch
quality-of-life assessment
questionnaire administration
Sponsored by
University of Iowa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Iowa Hospitals and Clinics

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm 1 (healing touch)

Arm II (usual care)

Arm Description

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 (therapeutic touch). Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration

Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. Interventions: quality-of-life assessment, and questionnaire administration

Outcomes

Primary Outcome Measures

Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
Changes in QoL (POMS-SF, FACT-BMT, CES-D)
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 Outcome Measures

Number of hospital readmissions

Full Information

First Posted
July 16, 2014
Last Updated
January 30, 2017
Sponsor
University of Iowa
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02194413
Brief Title
Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
Official Title
Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 18, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Iowa
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer, Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1 (healing touch)
Arm Type
Experimental
Arm Description
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 (therapeutic touch). Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration
Arm Title
Arm II (usual care)
Arm Type
Active Comparator
Arm Description
Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital. Interventions: quality-of-life assessment, and questionnaire administration
Intervention Type
Procedure
Intervention Name(s)
therapeutic touch
Other Intervention Name(s)
healing touch
Intervention Description
receiving healing touch
Intervention Type
Other
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
Time Frame
Up to 100 days
Title
Changes in QoL (POMS-SF, FACT-BMT, CES-D)
Description
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.
Time Frame
Baseline up to 100 days
Secondary Outcome Measure Information:
Title
Number of hospital readmissions
Time Frame
Up to 100 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susan K Lutgendorf, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

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