N/A
N=23
Massage for Pediatric Oncology
Bone Marrow Transplantation · Distress
Bottom Line
View on ClinicalTrials.gov: NCT00843180 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
May 2012
Primary outcome: 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) — 7.7; 8.3 days — p=0.80
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- massage (Other)
- Age
- Pediatric, Adult · 5+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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) |
7.7; 8.3 | 0.80 |
| SECONDARY Number of Vomiting Episodes |
4.6; 7.0 | 0.29 |
| SECONDARY Days of Hospital Stay |
39.1; 35.3 | 0.78 |
| SECONDARY Days to Recovery Neutrophil Count |
16.8; 18.7 | 0.70 |
Summary
Undergoing bone marrow transplantation (BMT) is associated with a high level of distress for patients and caregivers. Clinical research studies have reported benefits from massage for a) oncology patients, b) children, c) adults and children undergoing bone marrow transplants. A multi-center study of an intervention using a combination of massage therapy and a laugh cart to reduce distress in pediatric oncology patients undergoing BMT (PI: Phipps) is completed with results not yet published. There is still a need for independent studies to isolate the effect of massage for clinical outcomes (such as improved nausea and pain control) in children. Furthermore, this study will test the acceptability of an augmented massage intervention. In addition to provider-child massage, the augmented massage intervention includes training of the resident parent to provide additional parent-child massage, to relieve symptoms as needed. The goal of this augmented intervention is the improvement of symptom management in patients and decreased stress and feelings of helplessness in parents.
We propose a randomized pilot study at the UCSF pediatric bone marrow transplant center to assess the feasibility of a higher-quality study of the effects of massage in this population.
Aim 1: Determine the acceptability of a massage intervention for patients and parents on a pediatric bone marrow transplant unit.
Aim 2: Explore the logistics of implementing the augmented massage intervention at the bedside offered to consecutive patients over one year's time.
Aim 3: Collect preliminary data for patients and parents including patient clinical outcomes, quality of life, and satisfaction, and parental stress and mood to allow sample size calculations for further studies.
Eligibility Criteria
Inclusion Criteria
- Being 5 to 18 years old
- Admitted for BMT.
Rationale: This is a pediatric study for children up to age 18 admitted to the BMT unit. Questionnaires are not designed for children under age 5.
Exclusion Criteria
- Parent or child unable to answer questionnaire due to language limitations.
Rationale: The pilot character of the study with its limited budget does not include instruments in foreign languages, such as Chinese or Spanish. This could be a project for further studies.
Data sourced from ClinicalTrials.gov (NCT00843180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.