Massage Impact on Sleep in Pediatric Oncology

April 13, 2026 updated by: Children's Hospital of Philadelphia

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

This study aims to determine the impact of massage therapy for pediatric patients receiving intensive chemotherapy or stem cell transplant (SCT).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Not yet recruiting
        • Children's National Hospital
        • Contact:
          • Catriona Mowbray, PhD
          • Phone Number: 202-476-3723
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Expected to be an inpatient for at least 21 days
  3. Aged 12 to 21 years at enrollment.
  4. Inpatient at Children's National or Children's Hospital of Philadelphia (CHOP).

Exclusion Criteria:

  1. Cognitive impairment sufficient to preclude completing questionnaires appropriately
  2. Insufficient knowledge of English or Spanish that would prohibit completing the study instruments
  3. Previous enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm (CA)
Standard of care.
Other: Standard of care
Institutional standard of care treatment
Experimental: Intervention Arm (IA)
Massage therapy
Other: Massage therapy
Participants in IA will receive a 20-30-minute massage five days per week for 21 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in sleep quality as demonstrated by circadian activity rhythms (CARs)
Time Frame: 3 weeks
Amount of dysrgulation in CARs in the standard of care intervention compared to the amount of dysregulation in CARs in the massage therapy intervention. Dysregulation in CARs will be measured by actigraphy (24-h autocorrelation).
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Philadelphia

Collaborators

Children's National Research Institute
Massage Therapy Foundation

Investigators

  • Principal Investigator: Tracey Jubelirer, MD, Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 23, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

July 1, 2028

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 24, 2025

Study Record Updates

Last Update Posted (Actual)

April 15, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24-022048

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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