Women's and Children "Del Ponte" Hospital
Varese, Italy
NCT Number: NCT04243967
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.
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Notify Me45 year–55 year
Female
Interventional
Not applicable
Varese, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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):
Other names: Music
Standard perioperative management including perioperative care (without the use of music / music therapy)
Other names: Standard management
Time frame: The same day of the surgery, before anesthesia
Preoperative - HADS scale assessment
Time frame: Within 24 hours after surgery
Early postoperative - HADS scale assessment
Time frame: At 1-month follow-up clinical evaluation
Late postoperative - HADS scale assessment
Time frame: 1 hour after the end of the surgery
VAS 1 - Visual Analogic Scale assessment
Time frame: 3 hours after the end of the surgery
VAS 3 - Visual Analogic Scale assessment
Time frame: 8 hours after the end of the surgery
VAS 8 - Visual Analogic Scale assessment
Università degli Studi dell'Insubria
Other
Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial
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