Actively Recruiting

Phase Not Applicable
Age: 7Years - 19Years
All Genders
ID06424158

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

Led by Cook Children's Health Care System · Updated on 2024-05-23

100

Participants Needed

1

Research Sites

17 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the effects of massage therapy on pain, anxiety, and quality of life in children and teenagers aged 7 to 19 years who have undergone thoracic or lumbar spinal fusion surgery. This prospective, randomized study compares massage therapy to standard care during recovery. The goal is to understand how massage therapy might help improve postoperative experiences for pediatric patients facing these surgeries. Participants will be randomly assigned to one of two groups after surgery: a massage therapy group or a control group receiving usual care. Those in the massage group will receive at least two 30-minute sessions from a certified pediatric massage therapist on postoperative days two and either day four or five, with additional sessions every other day if hospitalized longer than six days. The massages focus on areas of need without manipulating the surgical incision. The control group will receive standard care without massage but will be monitored similarly. Participants will be followed during their hospital stay and through follow-up visits at weeks 2, 6, and 12. Pain, anxiety, vital signs, and quality of life will be assessed using various scales and questionnaires throughout the study period. The final assessment will occur at week 16 post-discharge via phone or mail. Researchers will collect data from medical records and direct patient reports to evaluate outcomes including pain levels, anxiety, opioid use, and quality of life.

CONDITIONS

Brief Title

Massage Therapy After Thoracic or Lumbar Surgery

Who Can Participate

Age: 7Years - 19Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients scheduled to undergo their first thoracic or lumbar spinal fusion surgery
  • Able to participate and perform in 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
Not Eligible

You will not qualify if you...

  • Scheduled for any spinal fusion other than thoracic or lumbar
  • Scheduled for a second or multiple thoracic or lumbar spinal fusion surgery
  • Previous cardiac surgery
  • Chronic pain syndromes
  • Chronic opioid usage
  • History of psychosis
  • Prolonged bleeding
  • Intubation greater than 24 hours
  • Illicit/recreational drug use
  • Paralysis diagnosis
  • History of chronic pain requiring medical intervention
  • Neuromuscular scoliosis diagnosis
  • Cerebral palsy diagnosis
  • Developmental delay characteristics

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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 - Inpatient stay duration (post-surgery)

Participants undergo thoracic or lumbar spinal fusion surgery as part of routine care. After surgery, participants randomized to the massage therapy group receive at least two 30-minute massage therapy sessions on postoperative days 2 and 4 or 5 during their hospital stay. Massage therapy may continue every other day if the hospital stay is six days or longer. Control group participants receive standard post-surgical care without massage therapy but are monitored similarly.

Visits on postoperative days 2, 4 or 5, and every other day if hospitalization is longer than five days

Post-operative Follow-up

Duration - 12 weeks post-discharge

Participants are followed up after hospital discharge with visits at weeks 2, 6, and 12 to assess pain, anxiety, and quality of life.

3 follow-up visits at weeks 2, 6, and 12

Long-term Monitoring

Duration - Week 16 post-discharge

Final study involvement includes a quality of life questionnaire administered by phone or mail at week 16 after hospital discharge.

1 remote follow-up contact (phone or mail)

Trial Site Locations

Total: 1 location

1

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

Actively Recruiting

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Research Team

T

Throy Campbell, PhD

K

Kristy Reyes

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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