Massage for Pediatric Oncology

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT00843180

First received: February 12, 2009

Last updated: May 2, 2012

Last verified: May 2012

History of Changes

Results First Received: February 7, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Supportive Care
Conditions:	Bone Marrow Transplantation Distress
Intervention:	Other: massage

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
November 2008-November 2009, 12 months UCSF Children's Hospital, Bone Marrow Transplant Unit

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
consecutive enrollment of all eligible admitted children. 2 teenage boys declined participation

Reporting Groups

	Description
Massage	massage and acupressure up to 3x/week for entire hospital stay
Control	usual care only as control arm hospital care during bone marrow transplant

Participant Flow: Overall Study

	Massage	Control
STARTED	16	7
COMPLETED	16	7
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Massage	massage and acupressure up to 3x/week for entire hospital stay
Control	usual care only as control arm hospital care during bone marrow transplant
Total	Total of all reporting groups

Baseline Measures

	Massage	Control	Total
Number of Participants [units: participants]	16	7	23
Age [units: participants]
<=18 years	16	7	23
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: years] Mean ± Standard Deviation	10.9 ± 3.7	13.7 ± 4.3	11.7 ± 4.0
Gender [units: participants]
Female	7	3	10
Male	9	4	13
Region of Enrollment [units: participants]
United States	16	7	23

Outcome Measures

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1. Primary:

Number of Days With Pain Scores >3 Measured on Numeric Rating Scale (Range 0-10; 0 for no Pain; 10 for Worst Pain Imaginable) [ Time Frame: 7 days pre to 21 days post transplant = 28 days ]

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2. Secondary:

Number of Vomiting Episodes [ Time Frame: day -7 to +21 around transplant date ]

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3. Secondary:

Days of Hospital Stay [ Time Frame: days of hospital stay after bone marrow transplant ]

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4. Secondary:

Days to Recovery Neutrophil Count [ Time Frame: hospital stay ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
small sample size limited number of time points for self-report assessments. the dose of the massage intervention averaged 1.8 massages per week, while the target dose was 3 per week.

Results Point of Contact:

Name/Title: Dr. Wolf Mehling, MD
Organization: UCSF
phone: 415-353 9506
e-mail: mehlingw@ocim.ucsf.edu

No publications provided

Responsible Party:	University of California, San Francisco
ClinicalTrials.gov Identifier:	NCT00843180 History of Changes
Other Study ID Numbers:	H41337-33343
Study First Received:	February 12, 2009
Results First Received:	February 7, 2012
Last Updated:	May 2, 2012
Health Authority:	United States: Institutional Review Board

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