Intraoperative Music Therapy in Gynecological Oncology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-19

Study Completion Date

2019-11-18

Brief Summary

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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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Detailed Description

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Conditions

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Music Therapy General Anesthesia Surgery Pain Gynecological Cancer Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Music therapy was administered before initiating anesthetic induction with the patient lying flat on the surgical table. A pair of non-reusable headphones (Disok, Alicante, Spain) were used in both groups which were connected to a tablet Fire 7 (Amazon, Seattle, WA, US) that was used as a music player device connected to Spotify. Two music lists were downloaded and reproduced without the need of access to WIFI to ensure good reproducibility. Group A was played a list consisting of rhythmic tones of 60-80bpm, music from the Seatwork 60bpm playlist with a duration of 11h and 5 minutes. Group B was played an empty playlist. Volume was set at a standard of 68dB. The surgical supervisor was responsible for opening the opaque envelope for each patient and to play the list according to the allocated group. Only the surgical supervisor knew the allocation for each patient, the rest of the surgical team were blinded to the allocation result.

Study Groups

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Group A

Headphones (Disok, Alicante, España)

Group Type EXPERIMENTAL

Headphones (Disok, Alicante, España)

Intervention Type DEVICE

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

Group B

Without music therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Headphones (Disok, Alicante, España)

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No