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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02194413
Other study ID # 201111724
Secondary ID P30CA086862
Status Completed
Phase N/A
First received July 16, 2014
Last updated January 30, 2017
Start date March 2012
Est. completion date January 18, 2017

Study information

Verified date January 2017
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 18, 2017
Est. primary completion date January 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
therapeutic touch
receiving healing touch
Other:
quality-of-life assessment
Ancillary studies
questionnaire administration
Ancillary studies

Locations

Country Name City State
United States University of Iowa Hospitals and Clinics Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
University of Iowa National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater Up to 100 days
Primary 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. Baseline up to 100 days
Secondary Number of hospital readmissions Up to 100 days
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