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Completed

NCT Number: NCT04694508

Intraoperative Music Therapy in Gynecological Oncology

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.

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Key information

Conditions

Music Therapy General Anesthesia Gynecological Cancer Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Sánchez-Migallón Pérez

Barcelona, 08025, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Headphones (Disok, Alicante, España)

Device

A pair of non-reusable headphones (Disok, Alicante, Spain)

Primary outcomes

  1. The reduction in postoperative pain in patients undergoing gynecological oncology surgery within the ERAS protocol with the use of music therapy.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study 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.

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 5, 2021
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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