Intraoperative Music Therapy in Gynecological Oncology

Pain Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694508
• Other study ID #: ID-RTF065
• Status: Completed
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: November 18, 2019

Study information

• Verified date: January 2021
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 18, 2019
• Est. primary completion date: November 18, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• General Anesthesia
• Gynecological Cancer
• Music Therapy
• Pain
• Pain, Postoperative
• Surgery

Intervention

Device:
• Headphones (Disok, Alicante, España)
A pair of non-reusable headphones (Disok, Alicante, Spain)

Locations

Country	Name	City	State
Spain	Virginia Sánchez-Migallón Pérez	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.	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.	1 year