The Impact of Massage Therapy on Post-Surgical Pain, Anxiety, Quality of Life, and Opioid Analgesia Exposure on Children After Thoracic or Lumbar Surgery

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this research is to look at the effect of massage therapy on the pain, anxiety, and quality of life that pediatric patients have after undergoing spinal fusion surgery. This is a single-site, prospective, randomized, interventional study design that will involve post-thoracic and post-lumbar spinal fusion surgeries of pediatric patients from 7 to 19 years of age that present to Cook Children's Medical Center in Fort Worth, Texas. These patients will be identified prior to their scheduled spinal fusion surgery and recruited to enroll in the study. The planned spinal fusion surgeries are not considered part of this research project, but rather considered standard of care and would occur whether the patient is enrolled in this project or not. Enrolled participants will be followed during their inpatient stay and through their subsequent follow-up visits at weeks 2, 6, and 12. Participants will be randomly assigned to either a massage therapy group or a group that receives the standard (normal) care for recovery after surgery. The final study involvement will occur at week 16 (post-hospital discharge) where a study team member will administer a quality of life (PedsQL) questionnaire via phone or mail with the subject. Data will be collected after study related procedures are completed.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 7
Maximum Age: 19
Healthy Volunteers: f
View:

• Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery

• Able to participate and perform in a massage therapy as a recovery option

• Participant needs to be verbal

• Ability to understand study procedures and to comply with them for the entire length of the study

Locations
United States
Texas
Cook Children's Medical Center
RECRUITING
Fort Worth
Contact Information
Primary
Throy Campbell, PhD
throy.campbell@cookchildrens.org
682-885-1044
Backup
Kristy Reyes
kristy.reyes@cookchildrens.org
682-885-1044
Time Frame
Start Date: 2021-02-17
Estimated Completion Date: 2026-08-01
Participants
Target number of participants: 100
Treatments
Experimental: Massage Therapy Group
Participants in the massage therapy group are treated by a certified pediatric massage therapist for at least two 30- minute massage therapy sessions performed on postoperative days two and four or five. Participants will continue to receive standard of care, including any pain medications as needed.
No_intervention: Control Group
Participants in control group will continue to receive the normal standard of care as usual for their recovery and will be monitored by hospital staff in obtaining the same data points recorded clinically for post-op days 2 and 4/5; however, no therapeutic intervention will occur.
Related Therapeutic Areas
Sponsors
Leads: Cook Children's Health Care System

This content was sourced from clinicaltrials.gov