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Completed

NCT Number: NCT02194413

Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

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.

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Key information

Conditions

Anxiety Disorder Anxiety Disorders Fatigue Hematologic Diseases Hematologic Neoplasms Hematopoietic/Lymphoid Cancer Hemic and Lymphatic Diseases Mental Disorders Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

therapeutic touch

Procedure

receiving healing touch

Other names: healing touch

Quality-of-Life Assessment

Other

Ancillary studies

Other names: quality of life assessment

Questionnaire Administration

Other

Ancillary studies

Primary outcomes

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

    Time frame: Up to 100 days

  2. 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

  1. Number of hospital readmissions

    Time frame: Up to 100 days

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Jul 18, 2014
Registry last updated
Feb 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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