Clinical trial · Interventional
Preoperative Music Listening in Odontostomatological Surgery (PMLOS)
Preoperative Music Listening Versus Intravenous Midazolam (PMLOS) on Anxiety, Sedation and Stress in Odontostomatological Surgery: a Randomized Controlled Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
People undergoing general anesthesia for oral cancer diagnosis and treatment often experience heightened anxiety, fear and stress with negative bodily responses, such as tachycardia, hypertension, increased myocardial consumption of O2, arrhythmias, increased peripheral resistance, hypercoagulability, immunodeficiency and catabolic response . Emotional distress and pain may be managed by pre-procedurally application of anxiolytic, analgesic, and anesthetic drugs, but with potential risks or side effects such as respiratory depression, nausea and vomiting, confusion, memory loss, hypoxemia, and drug-drug interactions. This may result in adverse outcomes, such as delayed healing, increased healthcare utilization, and cost. A recent Cochrane review showed that benzodiazepines reduce pre-procedural anxiety compared with placebo with a low quality of evidence. Music therapy (MT), defined as the clinical and evidence-based use of music interventions by a trained professional for the purpose of achieving individualized goals within a therapeutic relationship between patient, music and music therapist 6 , may be used as a safe and cost-effective complementary intervention in adjunct to standard surgical care. During surgery, music is a powerful positive stimulus that evokes and modulates emotions as well as mood, face mask adverse stimuli, and improves emotional health through coping. Music therapy and music medicine interventions are effective to prevent and treat emotional distress and pain before, during and after medical procedures . Evidence from Cochrane systematic reviews shows that music interventions affect positively anxiety in patients with cancer, coronary heart diseases and in patients on mechanical ventilation . Some studies reported also that music interventions reduced sedative requirements in patients undergoing surgery under regional anesthesia combined with sedation, both with midazolam and propofol and also in critically ill patients in intensive care units. The primary aim of this study was to evaluate the effects of preoperative music therapy intervention compared to premedication with midazolam on anxiety, sedation and stress during general anesthesia for odontostomatological elective surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage I or II Micro-invasive Oral Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| music therapy intervention | Other | — | UNRESOLVED |
| Standard Preparation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Treatement Group
- description
- Participants received music therapy intervention
- interventionNames
- Other: music therapy intervention
- type
- ACTIVE_COMPARATOR
- label
- Control Group
- description
- Patients in control group receive premedication
- interventionNames
- Drug: Standard Preparation
Primary outcomes (4)
- measure
- Anxiety
- timeFrame
- 30 minutes before
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \>18 years * no severe neurological or psychiatric conditions, * no hearing impairment, * no drugs abuse, * American Society of Anesthesiologists (ASA) score I to III Exclusion Criteria: * \< 18 years * severe neurological or psychiatric conditions, * hearing impairment, * drugs abuse, * American Society of Anesthesiologists (ASA) score IV to V
References
Publications (12)
- RESULTKoelsch S, Fuermetz J, Sack U, Bauer K, Hohenadel M, Wiegel M, Kaisers UX, Heinke W. Effects of Music Listening on Cortisol Levels and Propofol Consumption during Spinal Anesthesia. Front Psychol. 2011 Apr 5;2:58. doi: 10.3389/fpsyg.2011.00058. eCollection 2011. PMID 21716581
- RESULTMarcantonio ER, Juarez G, Goldman L, Mangione CM, Ludwig LE, Lind L, Katz N, Cook EF, Orav EJ, Lee TH. The relationship of postoperative delirium with psychoactive medications. JAMA. 1994 Nov 16;272(19):1518-22. PMID 7966844
- RESULTEbrahimi R, Shroyer AL, Dennis P, Currier J, Lendvai Wischik D. Music Can Reduce the Need for Pharmacologic Conscious Sedation During Invasive Coronary Angiography. J Invasive Cardiol. 2020 Nov;32(11):440-444. doi: 10.25270/jic/20.00132. Epub 2020 Oct 22. PMID 33087584
- RESULTBradt J, Dileo C. Music interventions for mechanically ventilated patients. Cochrane Database Syst Rev. 2014;2014(12):CD006902. doi: 10.1002/14651858.CD006902.pub3. Epub 2014 Dec 9. PMID 25490233
- RESULTChlan LL, Heiderscheit A, Skaar DJ, Neidecker MV. Economic Evaluation of a Patient-Directed Music Intervention for ICU Patients Receiving Mechanical Ventilatory Support. Crit Care Med. 2018 Sep;46(9):1430-1435. doi: 10.1097/CCM.0000000000003199. PMID 29727366
- RESULTPalmer JB, Lane D, Mayo D, Schluchter M, Leeming R. Effects of Music Therapy on Anesthesia Requirements and Anxiety in Women Undergoing Ambulatory Breast Surgery for Cancer Diagnosis and Treatment: A Randomized Controlled Trial. J Clin Oncol. 2015 Oct 1;33(28):3162-8. doi: 10.1200/JCO.2014.59.6049. Epub 2015 Aug 17. PMID 26282640
- RESULTLee JH. The Effects of Music on Pain: A Meta-Analysis. J Music Ther. 2016 Winter;53(4):430-477. doi: 10.1093/jmt/thw012. Epub 2016 Oct 19.