Clinical trial NCT04243967: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Pain, Postoperative
Keywords: Hysterectomy
Music therapy
Laparoscopy
Anxiety
Stress
Pain
Minimally invasive surgery
TLH
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2020-01-28
Enrollment: 100
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Anxiety
timeFrame: The same day of the surgery, before anesthesia
measure: Anxiety
timeFrame: Within 24 hours after surgery
measure: Anxiety
timeFrame: At 1-month follow-up clinical evaluation
Secondary outcomes:
measure: Pain (VAS)
timeFrame: 1 hour after the end of the surgery
measure: Pain (VAS)
timeFrame: 3 hours after the end of the surgery
measure: Pain (VAS)
timeFrame: 8 hours after the end of the surgery
Other outcomes:
Locations:
city: Varese
country: Italy
facility: Women's and Children "Del Ponte" Hospital
Study officials:
References:
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.