Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Change in total sleep minutes
Study Overview
Brief Summary
This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).
Detailed Description
Hospitalized pediatric oncology patients report anxiety, pain, disturbed sleep, and excess fatigue. Massage is safe, does not interfere with medications, and has been shown in limited studies to have efficacy in improving sleep as well as decreasing fatigue, anxiety and other symptoms in cancer patients and children with various ailments.
This project aims to determine if individualized massage therapy for hospitalized pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT) is associated with longer duration and improved quality of sleep, more robust circadian rhythms (CARs), improved quality of life (QOL) and reduced fatigue, anxiety, and pain, as compared to a standard of care group.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 21 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of cancer, such as acute myeloid leukemia (AML) or relapsed acute lymphoblastic leukemia (rALL) OR admitted to receive autologous or allogeneic HSCT for any indication
- •Expected to be an inpatient for at least 21 days
- •Aged 12 to 21 years at enrollment.
- •Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).
Exclusion Criteria
- •Cognitive impairment sufficient to preclude completing questionnaires appropriately
- •Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
- •Previous enrollment
Arms & Interventions
Control Arm (CA)
Standard of care.
Intervention: Standard of care (Other)
Intervention Arm (IA)
Massage therapy
Intervention: Massage therapy (Other)
Outcomes
Primary Outcomes
Change in total sleep minutes
Time Frame: 3 weeks
Change in the total number of sleep minutes over time in the standard of care intervention compared to the change in the total number of sleep minutes over time in the massage therapy intervention. Sleep minutes are measured by actigraphy.
Secondary Outcomes
- Change in sleep quality as demonstrated by circadian activity rhythms (CARs)(3 weeks)