Intraoperative Music Therapy in Gynecological Oncology | NCT04694508

Studies
Intraoperative Music Therapy in Gynecological Oncology

NCT04694508

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

Status

Completed

Last Update Posted

Jan 5, 2021Actual

Enrollment

80Actual

Phase

Not Applicable

Conditions

Music Therapy
General Anesthesia
Surgery
Pain
Gynecological Cancer
Pain, Postoperative

Interventions

Headphones (Disok, Alicante, España)

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 19, 2018Actual

Primary Completion Date

Nov 18, 2019Actual

Completion Date

Nov 18, 2019Actual

First Submitted Date

Dec 11, 2020

First Submission Date that Met QC Criteria

Jan 3, 2021

First Posted Date

Jan 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 3, 2021

Last Update Posted Date

Jan 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A	Experimental	Headphones (Disok, Alicante, España)	Device: Headphones (Disok, Alicante, España)
Group B	No Intervention	Without music therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Headphones (Disok, Alicante, España)	Device	A pair of non-reusable headphones (Disok, Alicante, Spain)	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

This is a clinical trial that enrolled all patients undergoing gynecological oncology surgery for ovarian, endometrial or cervical cancer by laparotomy, laparoscopy or robotic surgery.

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Virginia Sánchez-Migallón Pérez		Barcelona		08025	Spain

Condition Browse Module

MeSH Terms

ID	Term
D010146	Pain
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

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).

Masking Info

Masking

None (Open Label)

Masking Description

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.

Who Masked

Not provided