AnxietyNCT04243967
Music Therapy Pathway in Patients Undergoing Total Laparoscopic Hysterectomy
A study testing Music therapy in people with Anxiety and Pain, Postoperative, run by Università degli Studi dell'Insubria at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 to 55 years, women only
- Conditions the study is for
- Anxiety, Pain, Postoperative
- What is being tested?
- Music therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2020to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Adult women (45-55 years)
- Scheduled for total laparoscopic hysterectomy (+/- salpingectomy or salpingo-oophorectomy)
- Indication for surgery: presumed benign gynecologic disease
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Anxiety, Pain, Postoperative
- Being tested
- Music therapy, Control
- Keywords
- Hysterectomy, Music therapy, Laparoscopy, Anxiety, Stress, Pain, Minimally invasive surgery, TLH
- Medical subject headings
- Anxiety Disorders, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music therapyOther
Also called Music
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).
ControlOther
Also called Standard management
Standard perioperative management including perioperative care (without the use of music / music therapy)
| Study group | Role | What they receive |
|---|---|---|
| MUSIC THERAPY | Experimental | Not described Receives: Other: Music therapy |
| CONTROL | Experimental | Not described Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Preoperative - HADS scale assessment
Measured: The same day of the surgery, before anesthesia
Anxiety
Early postoperative - HADS scale assessment
Measured: Within 24 hours after surgery
Anxiety
Late postoperative - HADS scale assessment
Measured: At 1-month follow-up clinical evaluation
Secondary outcomes (3)
Pain (VAS)
VAS 1 - Visual Analogic Scale assessment
Measured: 1 hour after the end of the surgery
Pain (VAS)
VAS 3 - Visual Analogic Scale assessment
Measured: 3 hours after the end of the surgery
Pain (VAS)
VAS 8 - Visual Analogic Scale assessment
Measured: 8 hours after the end of the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Feb 2020
- Primary completion31 Jul 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Università degli Studi dell'Insubria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jvan Casarin, Università degli Studi dell'Insubria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243967
- Sponsor's protocol ID
- UInsubria_Gyn_19TLH
- Status last verified
- Jan 2021
- First submitted
- 21 Jan 2020
- Last updated
- 5 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 33549732
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Music Therapy Pathway to Reduce Preoperative Anxiety in Patients Undergoing Total Laparoscopic Hysterectomy for Benign Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04243967
- Acronym / sponsor ID
- UInsubria_Gyn_19TLH
- Conditions
- Anxiety, Pain, Postoperative
- Keywords
- Hysterectomy, Music therapy, Laparoscopy, Anxiety, Stress, Pain, Minimally invasive surgery, TLH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Università degli Studi dell'InsubriaUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 31 Jul 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MUSIC THERAPY | Experimental | Other: Music therapy |
| CONTROL | Experimental | Other: Control |
Who may qualify
- Ages
- 45 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult women (45-55 years)
- Scheduled for total laparoscopic hysterectomy (+/- salpingectomy or salpingo-oophorectomy)
- Indication for surgery: presumed benign gynecologic disease
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Music therapyAlso: MusicOn 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). | Other | MUSIC THERAPY |
| ControlAlso: Standard managementStandard perioperative management including perioperative care (without the use of music / music therapy) | Other | CONTROL |
Primary outcome
Anxiety
Time frame: The same day of the surgery, before anesthesia
Preoperative - HADS scale assessment
Anxiety
Time frame: Within 24 hours after surgery
Early postoperative - HADS scale assessment
Anxiety
Time frame: At 1-month follow-up clinical evaluation
Late postoperative - HADS scale assessment
3 secondary outcomes
Pain (VAS)
Time frame: 1 hour after the end of the surgery
Pain (VAS)
Time frame: 3 hours after the end of the surgery
Pain (VAS)
Time frame: 8 hours after the end of the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
- Derived from this study: PubMed 33549732Casarin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music therapy in people with Anxiety and Pain, Postoperative, run by Università degli Studi dell'Insubria at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: The same day of the surgery, before anesthesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04243967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.