This clinical trial evaluates the effects of live versus recorded music played prior to surgery (pre-operatively) on stress experienced by patients undergoing neurosurgical procedures. Neurosurgical procedures are widely used in patients with brain tumors. Surgical cancer patients are prone to elevated levels of anxiety and rumination, which have been associated with an exaggerated stress responses and poor health outcomes. Music has been frequently and successfully used to regulate mood and arousal in patients and has been found to enhance surgical performance and concentration among providers when played in the operating room. Live music, when compared with recorded music, has been shown to be more effective at altering stress markers and enhancing emotional wellbeing in patients. Pre-operative music interventions may be effective at reducing stress and improving mood outcomes in patients undergoing neurosurgical procedures.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT06536504.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Active
Contact: Mei Rui
Phone: 713-745-4243
PRIMARY OBJECTIVES:
I. To evaluate the effects of the two (live and recorded) prescribed pre-operative music interventions containing compositional elements of relaxation (CER) on physiologic and perceived stress in patients undergoing neurosurgery.
II. To evaluate the effects of those two music interventions on serum- and plasma-level stress biomarkers and cytokines in those patients in those patients.
SECONDARY OBJECTIVES:
I. Evaluation of the effect of music interventions on the following measurements:
Ia. Correlative effects of demographic variables;
Ib. Prior musical training;
Ic. Experience;
Id. Preference;
Ie. Exposure to music.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM A: Patients listen to simulated live music via a Steinway Spirio player grand piano for 30 minutes pre-operatively in the consultation room. Patients also undergo collection of blood samples on study.
ARM B: Patients listen to recorded music via ambient speakers for 30 minutes pre-operatively in the consultation room. Patients also undergo collection of blood samples on study.
ARM C: Per standard of care, patients listen to no music in the consultation room pre-operatively. Patients also undergo collection of blood samples on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorMei Rui
