Anxiety DisorderNCT02194413
Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
A study testing therapeutic touch, quality-of-life assessment and questionnaire administration in people with Anxiety Disorder and Fatigue, run by University of Iowa at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer
- What is being tested?
- therapeutic touch, quality-of-life assessment and questionnaire administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to 18 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
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.
Read the detailed description
Primary Objectives:
- 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
- Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer, Pain
- Being tested
- therapeutic touch, quality-of-life assessment, questionnaire administration
- Medical subject headings
- Anxiety Disorders, Fatigue, Hematologic Neoplasms, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic touchProcedure or surgery
Also called healing touch
receiving healing touch
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (healing touch) | Experimental | 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 Receives: Procedure: therapeutic touch; Other: quality-of-life assessment; Other: questionnaire administration |
| Arm II (usual care) | Active comparator | 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 Receives: Other: quality-of-life assessment; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
Measured: Up to 100 days
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.
Measured: Baseline up to 100 days
Secondary outcomes (1)
Number of hospital readmissions
Measured: Up to 100 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2014 (estimated)
- Study startMar 2012
- Primary completionJan 2016
- Study completion18 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Susan Lutgendorf, University of Iowa
- Investigators
- Susan K Lutgendorf, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02194413
- Sponsor's protocol ID
- 201111724
- Other IDs
- P30CA086862
- Status last verified
- Jan 2017
- First submitted
- 16 Jul 2014
- Last updated
- 1 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT02194413
- Acronym / sponsor ID
- 201111724
- Conditions
- Anxiety Disorder, Fatigue, Hematopoietic/Lymphoid Cancer, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Mar 2012 (actual)
- Primary completion
- Jan 2016 (actual)
- Study completion
- 18 Jan 2017 (actual)
- First posted
- 18 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (healing touch) | Experimental | Procedure: therapeutic touch, Other: quality-of-life assessment, Other: questionnaire administrationPatients 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) | Active comparator | Other: quality-of-life assessment, Other: questionnaire administrationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic touchAlso: healing touchreceiving healing touch | Procedure or surgery | Arm 1 (healing touch) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm 1 (healing touch), Arm II (usual care) |
| questionnaire administrationAncillary studies | Other | Arm 1 (healing touch), Arm II (usual care) |
Primary outcome
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
Time frame: Up to 100 days
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.
1 secondary outcome
Number of hospital readmissions
Time frame: Up to 100 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Susan K Lutgendorf, PhD principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic touch, quality-of-life assessment and questionnaire administration in people with Anxiety Disorder and Fatigue, run by University of Iowa at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater (time frame: Up to 100 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2017.