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临床试验/NCT05417529
NCT05417529已完成不适用

Preoperative Music Listening Versus Intravenous Midazolam (PMLOS) on Anxiety, Sedation and Stress in Odontostomatological Surgery: a Randomized Controlled Study

Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Anxiety

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • >18 years
  • no severe neurological or psychiatric conditions,
  • no hearing impairment,
  • no drugs abuse,
  • American Society of Anesthesiologists (ASA) score I to III

排除标准

  • < 18 years
  • severe neurological or psychiatric conditions,
  • hearing impairment,
  • drugs abuse,
  • American Society of Anesthesiologists (ASA) score IV to V

研究组 & 干预措施

Treatement Group

Experimental

Participants received music therapy intervention

干预措施: music therapy intervention (Other)

Control Group

Active Comparator

Patients in control group receive premedication

干预措施: Standard Preparation (Drug)

结局指标

主要结局

Anxiety

时间窗: 60 minutes after

Anxiety Visual Analogues Scale (A-VAS) was used to evaluate the level of anxiety from 0 (no anxiety) to 10 (maximum anxiety) before surgical procedure T0

Bispectral Index (BIS)

时间窗: during anesthesia induction

Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia. BIS monitors are used to supplement Guedel's classification system for determining depth of anesthesia. Titrating anesthetic agents to a specific bispectral index during general anesthesia in adults (and children over 1 year old) allows the anesthetist to adjust the amount of anesthetic agent to the needs of the patient, possibly resulting in a more rapid emergence from anesthesia. BIS monitoring is widely used in clinical anesthesia as an index for monitoring the electrical activity of the cerebral cortex and the sedative ingredients of anesthesia. BIS scores range from 0 to 100 (0, coma; 40-60, general anesthesia; 60-90, sedated; 100, awake) and reflect the level of sedation regardless of a patient's clinical characteristics or the type of sedative drug used.

Patient global impression of satisfaction (PGIS)

时间窗: through study completion, 1 hour after surgery

Patient global impression of satisfaction (PGIS) with a 4 items score ( 1=very dissatisfied, 2=dissatisfied, 3=satisfied, 4=very satisfied).

次要结局

  • O2SAT(during the procedure)
  • Heart Rate(during the procedure)
  • Blood Pressure (SBP-DPB)(during the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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