Actively Recruiting

Phase Not Applicable
Age: 12Years - 21Years
All Genders
ID06892158

Massage Impact on Sleep in Hospitalization for Pediatric Oncology and Stem Cell Transplant Patients

Led by Children's Hospital of Philadelphia · Updated on 2026-04-15

70

Participants Needed

2

Research Sites

26 weeks

Total Duration

On this page

Sponsors

C

Children's Hospital of Philadelphia

Lead Sponsor

M

Massage Therapy Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to evaluate the effects of massage therapy on hospitalized pediatric patients aged 12 to 21 years who are receiving intensive chemotherapy or stem cell transplant (SCT) for cancer, including acute myeloid leukemia or relapsed acute lymphoblastic leukemia. The study explores whether individualized massage can improve sleep duration and quality, enhance circadian rhythms, and reduce fatigue, anxiety, and pain compared to standard care. This trial is sponsored by the Children's Hospital of Philadelphia. Participants are randomly assigned to either receive standard care or massage therapy. Those in the massage group will get a 20- to 30-minute massage five days a week for three weeks (21 days). The control group will receive the institutional standard of care without massage. This intervention is provided during hospitalization at either Children's National or Children's Hospital of Philadelphia. Throughout the study, researchers will monitor sleep changes using total sleep minutes over three weeks as the primary outcome. Secondary measures include sleep quality assessed by circadian activity rhythms, quality of life, fatigue, anxiety, and pain levels. Participants will complete questionnaires, and their sleep and activity patterns will be tracked to assess the effects of massage therapy during their inpatient stay. The total study duration per participant is about three weeks.

CONDITIONS

Brief Title

Massage Impact on Sleep in Pediatric Oncology

Who Can Participate

Age: 12Years - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of cancer such as acute myeloid leukemia or relapsed acute lymphoblastic leukemia or admitted for autologous or allogeneic hematopoietic stem cell transplant
  • Expected inpatient hospital stay of at least 21 days
  • Aged 12 to 21 years at enrollment
  • Current inpatient at Children's National or Children's Hospital of Philadelphia
Not Eligible

You will not qualify if you...

  • Cognitive impairment that prevents proper completion of questionnaires
  • Insufficient knowledge of English or Spanish to complete study instruments
  • Previous enrollment in the study

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 21 days

Participants receive either individualized massage therapy or standard care during hospitalization.

Massage therapy for 20-30 minutes, five days per week for 3 weeks

Trial Site Locations

Total: 2 locations

1

Children's National Hospital

Washington D.C., District of Columbia, United States, 20010

Not Yet Recruiting

2

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

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Research Team

L

Lauren Vernau

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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