search
Back to results

Music Therapy Pathway in Patients Undergoing Total Laparoscopic Hysterectomy

Primary Purpose

Anxiety, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Music therapy
Control
Sponsored by
Università degli Studi dell'Insubria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Anxiety focused on measuring Hysterectomy, Music therapy, Laparoscopy, Anxiety, Stress, Pain, Minimally invasive surgery, TLH

Eligibility Criteria

45 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Women's and Children "Del Ponte" Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MUSIC THERAPY

CONTROL

Arm Description

Outcomes

Primary Outcome Measures

Anxiety
Preoperative - HADS scale assessment
Anxiety
Early postoperative - HADS scale assessment
Anxiety
Late postoperative - HADS scale assessment

Secondary Outcome Measures

Pain (VAS)
VAS 1 - Visual Analogic Scale assessment
Pain (VAS)
VAS 3 - Visual Analogic Scale assessment
Pain (VAS)
VAS 8 - Visual Analogic Scale assessment

Full Information

First Posted
January 21, 2020
Last Updated
January 2, 2021
Sponsor
Università degli Studi dell'Insubria
search

1. Study Identification

Unique Protocol Identification Number
NCT04243967
Brief Title
Music Therapy Pathway in Patients Undergoing Total Laparoscopic Hysterectomy
Official Title
Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2020 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
August 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università degli Studi dell'Insubria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Hysterectomy is the second most common surgical procedure in the United States. Uterine fibroids (with or without the association of heavy menstrual bleeding) represent the primary indication for surgery. Prospective controlled trials have shown that the laparoscopic approach guarantees benefits in terms of perioperative surgical outcomes and better patients' quality of life if compared with open surgery. Music is a non-invasive, safe, and inexpensive intervention that can be delivered easily and successfully. Results of a recent meta-analysis of 73 RCTs demonstrated that music could be offered as a way to help patients reducing pain and anxiety during the postoperative period. Recently a prospective randomized trial demonstrated a reduction of anxiety also in patients undergoing gynecological minor procedures (office hysteroscopy). Thanks to the use of a validated scale for assessing the preoperative and postoperative level of anxiety (STAI: State-Trait Anxiety Inventory), an Italian group demonstrated an average reduction of approximately 5 points of STAI score in patients enrolled for listening to music before surgery compared to the control group (without music). Similarly, a RCT demonstrated that preoperative music intervention might also reduce the postoperative pain in patients undergoing cesarean section (reduction of 1.35 VAS points at 6 hours). A recent meta-analysis evaluated music interventions for improving psychological and physical outcomes in adult and pediatric patients with cancer, showing a lower state of anxiety and greater pain reduction in participants who received music interventions. No study has been performed that aimed to investigate the role of music on anxiety and perception of pain in patients undergoing elective hysterectomy for benign disease, up to now. A comparison with a superiority trial is required to evaluate the effects of music played preoperatively in women undergoing total laparoscopic hysterectomy for benign disease. Our findings will offer evidence in favor of the use of music therapy as a method to reduce perioperative anxiety and postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Pain, Postoperative
Keywords
Hysterectomy, Music therapy, Laparoscopy, Anxiety, Stress, Pain, Minimally invasive surgery, TLH

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MUSIC THERAPY
Arm Type
Experimental
Arm Title
CONTROL
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Music therapy
Other Intervention Name(s)
Music
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Standard management
Intervention Description
Standard perioperative management including perioperative care (without the use of music / music therapy)
Primary Outcome Measure Information:
Title
Anxiety
Description
Preoperative - HADS scale assessment
Time Frame
The same day of the surgery, before anesthesia
Title
Anxiety
Description
Early postoperative - HADS scale assessment
Time Frame
Within 24 hours after surgery
Title
Anxiety
Description
Late postoperative - HADS scale assessment
Time Frame
At 1-month follow-up clinical evaluation
Secondary Outcome Measure Information:
Title
Pain (VAS)
Description
VAS 1 - Visual Analogic Scale assessment
Time Frame
1 hour after the end of the surgery
Title
Pain (VAS)
Description
VAS 3 - Visual Analogic Scale assessment
Time Frame
3 hours after the end of the surgery
Title
Pain (VAS)
Description
VAS 8 - Visual Analogic Scale assessment
Time Frame
8 hours after the end of the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult women (45-55 years) Scheduled for total laparoscopic hysterectomy (+/- salpingectomy or salpingo-oophorectomy) Indication for surgery: presumed benign gynecologic disease Exclusion Criteria: 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
Facility Information:
Facility Name
Women's and Children "Del Ponte" Hospital
City
Varese
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
33549732
Citation
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.
Results Reference
derived

Learn more about this trial

Music Therapy Pathway in Patients Undergoing Total Laparoscopic Hysterectomy

We'll reach out to this number within 24 hrs