Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant

NCT ID: NCT02194413

Last Updated: 2017-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2017-01-18

Brief Summary

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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

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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.

Conditions

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Anxiety Disorder Fatigue Hematopoietic/Lymphoid Cancer Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm 1 (healing 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

Group Type EXPERIMENTAL

therapeutic touch

Intervention Type PROCEDURE

receiving healing touch

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Arm II (usual care)

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

Group Type ACTIVE_COMPARATOR

quality-of-life assessment

Intervention Type OTHER

Ancillary studies

questionnaire administration

Intervention Type OTHER

Ancillary studies

Interventions

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therapeutic touch

receiving healing touch

Intervention Type PROCEDURE

quality-of-life assessment

Ancillary studies

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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healing touch quality of life assessment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

University of Iowa

OTHER

Sponsor Role lead

Responsible Party

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Susan Lutgendorf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan K Lutgendorf, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Iowa

Locations

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University of Iowa Hospitals and Clinics

Iowa City, Iowa, United States

Site Status

Countries

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United States

Other Identifiers

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P30CA086862

Identifier Type: NIH

Identifier Source: secondary_id

View Link

201111724

Identifier Type: -

Identifier Source: org_study_id

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