Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

Pain Clinical Trial

Official title:

Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

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
• 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

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Fatigue
• Hematopoietic/Lymphoid Cancer
• Pain

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