Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

Not Applicable

Completed

• Conditions: Hematopoietic/Lymphoid Cancer; Pain; Anxiety Disorder; Fatigue
• Interventions: Procedure: therapeutic touch; Other: questionnaire administration; Other: quality-of-life assessment

• Registration Number: NCT02194413
• Lead Sponsor: University of Iowa

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-07-17
• Study First Posted: 2014-07-18
• Primary Completion: 2016-01
• Status Verified: 2017-01
• Study Completion: 2017-01-18
• Last Update Submitted: 2017-01-30
• Last Update Posted: 2017-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (usual care)	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
Arm 1 (healing touch)	quality-of-life assessment	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 II (usual care)	quality-of-life assessment	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
Arm 1 (healing touch)	therapeutic touch	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 1 (healing touch)	questionnaire administration	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

Primary Outcome Measures

Name	Time	Method
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater	Up to 100 days
Changes in QoL (POMS-SF, FACT-BMT, CES-D)	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 Outcome Measures

Name	Time	Method
Number of hospital readmissions	Up to 100 days

Trial Locations

Locations (1)

University of Iowa Hospitals and Clinics; 🇺🇸 Iowa City, Iowa, United States