Music Therapy Pathway in Patients Undergoing Total Laparoscopic Hysterectomy

Not Applicable

Completed

• Conditions: Anxiety; Pain, Postoperative

• Registration Number: NCT04243967
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Study Timeline

• Study First Submitted: 2020-01-21
• Study First Submitted QC: 2020-01-24
• Study First Posted: 2020-01-28
• Study Start: 2020-02-01
• Primary Completion: 2020-07-31
• Study Completion: 2020-08-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-02
• Last Update Posted: 2021-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Anxiety	At 1-month follow-up clinical evaluation	Late postoperative - HADS scale assessment

Secondary Outcome Measures

Name	Time	Method
Pain (VAS)	8 hours after the end of the surgery	VAS 8 - Visual Analogic Scale assessment

Trial Locations

Locations (1)

Women's and Children "Del Ponte" Hospital; 🇮🇹 Varese, Italy