NCT04243967

Brief Summary

Music therapy is a non-invasive, safe, and inexpensive intervention that can be easily and successfully delivered. it has been shown that music therapy might reduce the postoperative pain in patients undergoing cesarean section and in those with cancer, showing a lower state of anxiety and greater pain reduction in participants who received music interventions. The aim of the present study is to investigate the role of music and music therapy on anxiety and perception of pain in patients undergoing elective hysterectomy for benign disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable anxiety

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 21, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

January 21, 2020

Last Update Submit

January 2, 2021

Conditions

AnxietyPain, Postoperative

Keywords

HysterectomyMusic therapyLaparoscopyAnxietyStressPainMinimally invasive surgeryTLH

Outcome Measures

Primary Outcomes (3)

  • Anxiety

    Preoperative - HADS scale assessment

    The same day of the surgery, before anesthesia

  • Anxiety

    Early postoperative - HADS scale assessment

    Within 24 hours after surgery

  • Anxiety

    Late postoperative - HADS scale assessment

    At 1-month follow-up clinical evaluation

Secondary Outcomes (3)

  • Pain (VAS)

    1 hour after the end of the surgery

  • Pain (VAS)

    3 hours after the end of the surgery

  • Pain (VAS)

    8 hours after the end of the surgery

Study Arms (2)

MUSIC THERAPY

EXPERIMENTAL
Other: Music therapy

CONTROL

EXPERIMENTAL
Other: Control

Interventions

Music therapyOTHER

On the surgery day, the patient is accompanied by music-therapist all the way from her room to the operating theatre in order to monitor and adapt music-therapy intervention. The patient, prior to the anesthetic, take faces 3 phases of music therapy intervention (1 hour): * 1° Phase Active Music therapy: the patient takes part in a session of live improvisational music therapy, with the therapist, to elaborate pre-operative stress. * 2° Phase Relaxation with Receptive Live Music: music therapist play live to relax patients with autogenic training and tunnings breathing. * 3° Phase playlist listening based on the patient's needs. Patients listen to music with an mp3 player with earphones within the ear canal (H\&H CE mp3/Usb; Headphones on Air in-ear with volume control) with a maximum volume of 60 dB (previously set with a sound level meter).

Also known as: Music
MUSIC THERAPY
ControlOTHER

Standard perioperative management including perioperative care (without the use of music / music therapy)

Also known as: Standard management
CONTROL

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adult women (45-55 years)
  • Scheduled for total laparoscopic hysterectomy (+/- salpingectomy or salpingo-oophorectomy)
  • Indication for surgery: presumed benign gynecologic disease

You may not qualify if:

  • Any other associated non-gynecologic procedure to hysterectomy
  • History of previous malignancy
  • Individuals with hearing impairment (total or partial hearing difficulties)
  • Patients with neuropathic pain/chronic pain needing regular anti-inflammatory drugs
  • Non-Italian speaking patients
  • Inability to provide informed consent
  • Currently enrolled in any other research study involving drugs or devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Children "Del Ponte" Hospital

Varese, Italy

Location

Related Publications (1)

  • Casarin J, Cromi A, Sgobbi B, Di Siena A, Serati M, Bolis ME, Ghezzi F. Music Therapy for Preoperative Anxiety Reduction in Women Undergoing Total Laparoscopic Hysterectomy: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2021 Sep;28(9):1618-1624.e1. doi: 10.1016/j.jmig.2021.02.002. Epub 2021 Feb 5.

    PMID: 33549732DERIVED

MeSH Terms

Conditions

Anxiety DisordersPain, PostoperativePain

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental DisordersPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Research Associate

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 28, 2020

Study Start

February 1, 2020

Primary Completion

July 31, 2020

Study Completion

August 31, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

IT(1)