Clinical trial NCT04694508: Intraoperative Music Therapy in Gynecological Oncology
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Music Therapy
General Anesthesia
Surgery
Pain
Gynecological Cancer
Pain, Postoperative
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2021-01-05
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients were randomly assigned to either receiving intraoperative music therapy (Group A) or undergoing standard management without music therapy (Group B). Randomization was performed by a nurse specialist blinded to the study using anonymized, opaque envelopes provided by the Vall d'Hebron Research Institute. Participants were then randomized (i.e. given an envelope) to either Group A or Group B during the preoperative visit. The randomization allocation was performed using the ralloc function in STATA which randomly assigned participants in either of the two study groups in blocks of 2, 4, 6, until the total number of patients was achieved (n = 80).
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing gynecological oncology surgery for ovarian, endometrial or cervical cancer by laparotomy, laparoscopy or robotic surgery.
* ASA grade I-III
* Signed an informed consent prior to inclusion

Exclusion Criteria:

* ASA IV
* Active ischemic cardiopathy
* Hearing impairment
* Hormonal disfunction
* Active treatment with steroids
* Ppsychiatric disorder
* Contraindication for epidural anesthesia or failure of the technique in the peri-operative period.

Primary outcomes:
measure: The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Virginia Sánchez-Migallón Pérez
Study officials:
References: