Loading clinical trials...
Loading clinical trials...
Intraoperative Music Therapy for the Reduction of Postoperative Pain in Patients Undergoing an Enhanced Recovery After Surgery Protocol in Gynecological Oncology : A Randomized Controlled Trial.
Background Perioperative anxiety and postoperative pain can impact surgical morbidity. We aimed to evaluate the effect of intraoperative music therapy in the reduction of immediate postoperative pain in patients undergoing gynecological oncology surgery within an Enhanced Recovery After Surgery (ERAS) protocol. Secondary objectives include reduction in preoperative anxiety, postoperative pain overtime, neurohormonal response, morbidity, length of hospital stay (LOS) and patient satisfaction. Methods Prospective, randomized, double-blinded single-center study including patients undergoing surgery for ovarian, endometrial or cervical cancer over a period of 12 months. Patients were randomly assigned to receiving intraoperative music therapy (Group A) or undergoing standard management (Group B). A reduction in immediate postoperative pain was defined as a reduction in ≥2 points in the Verbal Rating Scale(VRS) at 4h postoperatively. Hemodynamic variables and blood samples were collected during the procedure for determination of cortisol levels. A scale of closed numeric questions (Likert-like) was used to assess patient satisfaction.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Virginia Sánchez-Migallón Pérez
Barcelona, Spain
Start Date
November 19, 2018
Primary Completion Date
November 18, 2019
Completion Date
November 18, 2019
Last Updated
January 5, 2021
80
ACTUAL participants
Headphones (Disok, Alicante, España)
DEVICE
Lead Sponsor
Hospital Universitari Vall d'Hebron Research Institute
NCT06430957
NCT05128890
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions