Intraoperative Music Therapy in Gynecological Oncology

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Gynecological Cancer; Surgery; General Anesthesia; Pain, Postoperative; Pain; Music Therapy

Treatments: Device: Headphones (Disok, Alicante, España)

Study type: Interventional

Funder types: Other

Identifiers

NCT04694508

ID-RTF065

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Group A

Experimental group

Description:

Headphones (Disok, Alicante, España)

Treatment:

Device: Headphones (Disok, Alicante, España)

Group B

No Intervention group

Description:

Without music therapy