跳至主要内容
临床试验/NCT03078790
NCT03078790已完成不适用

Implementing a Paced Deep Breathing Module to Decrease Preoperative Anxiety in Gynecological Surgery Patients

Mayo Clinic1 个研究点 分布在 1 个国家目标入组 38 人开始时间: 2017年3月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
38
试验地点
1
主要终点
change from baseline anxiety score

研究概览

简要总结

Preoperative anxiety is a common occurrence for many patients undergoing all types of surgery. Patients with a high level of anxiety before surgery have been shown to have numerous negative outcomes both intra-operatively and post-operatively. Many studies have shown that preoperative psychological interventions that aim to reduce anxiety also result in improved post-operative behavioral and clinical recovery. Currently, the most common method to treat preoperative anxiety is the administration of a prescription benzodiazepine. However, there is limited clinical evidence that supports the use of sedative premedication, such as with a benzodiazepine, before surgery. Complementary integrative medical therapies including music, massage, guided imagery, and deep breathing have been proposed to minimize stress and pain in surgical patients. These therapies are thought to be effective by evoking the relaxation response through stimulation of the parasympathetic nervous system and engagement of the patient in the healing process. Relaxation and deep breathing, particularly, have been shown to reduce pain, anxiety, and "tension-anxiety" in hospitalized patients. Based on this evidence, a guided paced deep breathing module has been proposed to reduce preoperative anxiety in patients undergoing gynecological surgery at Mayo Clinic Rochester Methodist Hospital. In this study, patients' anxiety will be assessed pre-intervention on a 0-10 numeric rating scale, as well as post-intervention and a paired t-test will be used to assess effectiveness. Additionally, qualitative questions will be administered via a questionnaire post-intervention to gain more insight on the effectiveness of the intervention. The feasibility of the intervention in the busy preoperative setting will be evaluated by assessing how many times a patient is interrupted while participating in the paced deep breathing module. If this module is found to be effective in reducing patients' anxiety, it will be implemented into practice so that every patient undergoing gynecological surgery, at the institution, will be offered the module preoperatively.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •aged 18 years or older
  • •undergoing gynecological surgery at Rochester Methodist Hospital
  • •roomed in pre-operative area on Eisenberg 1-4
  • •English-speaking
  • •Able to complete pre- and post-intervention questionnaires
  • •Able to read and understand informed consent form

排除标准

  • •Non-English speaking women
  • •first-case of the day gynecological surgery patients

研究组 & 干预措施

meditation module

Experimental

The patients in this arm will be offered the meditation/deep breathing module in the pre-operative area.

干预措施: iPad (Device)

结局指标

主要结局

change from baseline anxiety score

时间窗: recorded immediately pre-intervention and immediately post-intervention (once meditation module is complete)

rated 0 (no anxiety) to 10 (worst anxiety possible) on a numeric rating scale

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Natalie A. Laska

Principle investigator

Mayo Clinic

研究点 (1)

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