Clinical Trials Logo

Clinical Trial Summary

The goal of this feasibility clinical trial is to learn if melatonin can help teens having major musculoskeletal surgery by promoting healthy sleep. Melatonin is available as a dietary supplement that may be effective in promoting longer, higher quality sleep. This study will assess the feasibility and acceptability of melatonin for teens undergoing major musculoskeletal surgery, as well as determine optimal measured outcomes (sleep, pain, health-related quality of life) at short- and long-term follow-up.


Clinical Trial Description

The investigators will enroll a total of 45 adolescents ages 12-18 years old who are scheduled to undergo major musculoskeletal surgery and one of their caregivers who meet inclusion and exclusion criteria. Participants will be asked to: 1. Take melatonin or a placebo before and after surgery. All participants will receive sleep hygiene instructions. 2. Wear a watch-like actigraphy device before and after surgery 3. Complete 1-minute check-in surveys twice each day, for about 5 weeks total before and after surgery 4. Complete 10-20-minute online surveys 3 times over 4 months. Researchers will compare participants randomized to the placebo arm and melatonin arm to see if the trial design and outcomes are both feasible and acceptable to patients and their families. The main aims are: Aim 1. To assess the feasibility and acceptability of melatonin for youth undergoing musculoskeletal surgery Aim 2. To determine optimal primary and secondary outcomes (sleep, pain, health-related quality of life) at short-term (during the initial 21 days) and at final follow-up (3 months after surgery). The investigators will examine completion rates, the extent and pattern of missing data, and gather data to provide effect estimates, variances, and 95% confidence intervals. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06093477
Study type Interventional
Source Stanford University
Contact Jennifer A Rabbitts, M.B.Ch.B.
Phone (650) 427-0187
Email surgerysmart@stanford.edu
Status Recruiting
Phase N/A
Start date May 30, 2024
Completion date June 2028

See also
  Status Clinical Trial Phase
Recruiting NCT03883022 - Vancomycin Powder Combined With Autogenous Bone Graft as a Prevention for Post-operative Infection for Spine Surgery N/A
Active, not recruiting NCT04542577 - PMCF Study on the Safety and Performance of PROSPACE 3D / PROSPACE 3D OBLIQUE / TSPACE 3D
Recruiting NCT04477447 - PMCF Study on the Safety and Performance of CESPACE 3D
Completed NCT02558621 - New Robotic Assistance System for Spinal Fusion Surgery N/A
Terminated NCT01461005 - A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS) N/A
Completed NCT00405691 - Safety and Effectiveness Study of the TOPS System, a Total Posterior Arthroplasty Implant Designed to Alleviate Pain Resulting From Moderate to Severe Lumbar Stenosis Phase 3
Completed NCT00205101 - Clinical Outcome Study of the Triad Allograft for Posterior Lumbar Fusion
Enrolling by invitation NCT04204135 - The Course of Hip Flexion Weakness Following LLIF or ALIF
Recruiting NCT05238740 - Comparison of Standalone Anterior Lumbar Interbody Fusion (ALIF) L5/S1 Performed With Either rhBMP-2 or ViviGen® N/A
Not yet recruiting NCT02805985 - Post-market Surveillance Study of FLXfit™ TLIF Interbody Fusion Device N/A
Completed NCT02966639 - Validation of Appropriateness Criteria for the Surgical Treatment of Lumbar Degenerative Spondylolisthesis
Completed NCT02931279 - PASS OCT® Post-market Clinical Follow-up
Active, not recruiting NCT02057744 - MIS ReFRESH: Robotic vs. Freehand Minimally Invasive Spinal Surgeries
Completed NCT01711203 - The Addition of a Pilates Program for Short-Term Improvements in Patients With Spondylolysis or Spondylolisthesis N/A
Completed NCT00549913 - Study of 3 Doses of NeoFuse Combined With MasterGraft Granules in Subjects Requiring Posterolateral Lumbar Fusion (PLF) Phase 1/Phase 2
Terminated NCT00254852 - Evaluation of Radiographic and Patient Outcomes Following Lumbar Spine Fusion Using Demineralized Bone Matrix (DBM) Mixed With Autograft N/A
Terminated NCT00095095 - Lumbar Interbody Fusion Using the Telamon® Peek™ Versus the Telamon® Hydrosorb™ Fusion Device Phase 4
Active, not recruiting NCT03956537 - PMCF Neo Pedicle Screw and Cage Systems
Recruiting NCT05182489 - Adaptix RCT Evaluating Adaptix™ Versus PEEK Cages N/A
Completed NCT02884440 - Transverse Abdominis Plane Block for Anterior Approach Spine Surgery Phase 2