Intraoperative Music Therapy in Gynecological Oncology

Not Applicable

Completed

• Conditions: Music Therapy; Surgery; General Anesthesia; Gynecological Cancer; Pain, Postoperative; Pain
• Interventions: Device: Headphones (Disok, Alicante, España)

• Registration Number: NCT04694508
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-11-19
• Primary Completion: 2019-11-18
• Study Completion: 2019-11-18
• Study First Submitted: 2020-12-11
• Status Verified: 2021-01
• Study First Submitted QC: 2021-01-03
• Last Update Submitted: 2021-01-03
• Study First Posted: 2021-01-05
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Headphones (Disok, Alicante, España)	Headphones (Disok, Alicante, España)

Primary Outcome Measures

Name	Time	Method
The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.	1 year	The main objective of this study was to evaluate the reduction in postoperative pain, defined as a reduction in two or more points in the VRS, in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy. VRS is verbal rating score is a numeric rating scale (NRS-11) is an 11-point scale for patient self-reporting of pain. 0 means you have no pain; one to three means mild pain; four to seven is considered moderate pain; eight and above is severe pain.

Trial Locations

Locations (1)

Virginia Sánchez-Migallón Pérez; 🇪🇸 Barcelona, Spain