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临床试验/NCT05632679
NCT05632679招募中不适用

Effects of a Personalized Sound Intervention on Anxiety, Pain, and Satisfaction During Autogenous Gingival Graft in Adults: A Randomized Controlled Trial

Université de Montréal6 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
6
主要终点
burden of care

研究概览

简要总结

Anxiety feeds the avoidance of dental treatments, leading to the neglect of general oral health. This avoidance is often amplified by the fear of potential pain and dissatisfaction after a dental appointment. A music listening intervention could be beneficial to reduce anxiety, pain and dissatisfaction. This intervention has the advantage to be non-invasive, cheap, and easy to implement in clinical settings. The objective of this study is to explore the effects of a personalised musical intervention on anxiety, pain and dissatisfaction associated with an autogenous gingival graft in comparison to the use of an audiobook (control). In this regard, three groups of patients will receive the gingival graft along with the personalized music intervention (n=20), an audiobook (n=20) or standard care (n=20). Participants will be distributed randomly between conditions in a single blind design (surgeons will be unaware of the condition). However, since the third standard care control group was added as of 07-01-2023, all recruited participants will be enrolled in the standard care control group (non-randomized). Self-reported measures of anxiety, pain, and dissatisfaction will be taken at different times (baseline, preoperative, postoperative, and follow-up).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

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

  • Need a gingival graft that will not exceed 1.5 hour of surgery
  • Understand spoken and written French or English
  • Has the capacity to understand procedures and follow instructions
  • Consent to follow instructions
  • Consent to receive either the active or control sound condition
  • Being 18 years or older

排除标准

  • Do not need a gingival graft
  • Need a gingival graft that will last more than 1.5 hour of surgery
  • Mental health or neurological disorders
  • Auditory disorder
  • Allergy or intolerance to NSAIDS

结局指标

主要结局

burden of care

时间窗: 2 weeks postop

anxiety, pain and satisfaction measured using VAS scales (0 - 10mm; 0= no anxiety, no pain, no satisfaction, and 10= maximum anxiety, worst pain imaginable, maximum satisfaction)

次要结局

  • sociodemographic data(1 week before surgery)
  • participants' expectations(2 weeks postop)
  • State-trait anxiety inventory (Spielberg DC et al, 1977)(2 weeks postop)
  • State-trait anxiety inventory(immediately after surgery)
  • Cafeine and medications consumption(2 weeks postop)
  • Index of dental anxiety and fear(2 weeks postop)
  • Anxiety coping strategies(1 week before surgery)
  • Feelings at the present moment(immediately after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Robert Durand

Professor

Université de Montréal

研究点 (6)

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