跳至主要内容
临床试验/NCT05058079
NCT05058079Unknown不适用

The Effect of Hand Holding on Patient Satisfaction During for Minimally Invasive Spine Surgery Under Monitored Anesthesia Care. A Single Blinded, Single Center Randomized Controlled Trial

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 154 人开始时间: 2021年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
154
试验地点
1
主要终点
Iowa Satisfaction with Anesthesia Scale (ISAS)

研究概览

简要总结

The investigators want to determine whether handholding improves patient satisfaction and reduce patient's anxiety during minimally invasive outpatient spine surgery with monitored anesthesia care.

详细描述

Minimally invasive spine interventions have emerged as a treatment options for patients with previous spine surgery and patients who have never before been operated upon. These procedures can be done safely in patients with advanced comorbid conditions, previous failed major spine procedures, and in patients who have decided to try the least invasive approach to address their lumbo-sacral spine condition in hopes of avoiding more major and potentially morbid procedures. These endoscopic procedures are typically done as outpatients with light sedation, ideally rendering the patient calm but completely cooperative and able to respond in real-time to questions from the surgeon during the procedure. This has implications for the progress and success of the procedure, the safety of the procedure and allows for a short ambulatory hospital stay.

Hand holding has been shown to improve outcomes such as compliance, procedural success and patient comfort with patients undergoing light sedation for a variety of procedures. The purpose of this study is to determine whether adding hand holding to light sedation for minimally invasive spine procedures has a positive impact on patient satisfaction and perioperative outcomes.

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
Single (Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •American Society of Anesthesiology physical status 1 to 3
  • •Outpatient endoscopic spine procedures under light sedation

排除标准

  • •American Society of Anesthesiology physical status 4 or greater
  • •Pre-existing neuropathy
  • •Infection at the site
  • •Pregnancy
  • •Patient's refusal or inability to consent

研究组 & 干预措施

Hand-held group

Active Comparator

Patients hand will be held by the anesthesia provider during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will have their hand under the folded blanket holding the patient's hand.

干预措施: Intraoperative Hand Held (Behavioral)

No hand holding group

No Intervention

No physical contact for comfort or reassurance during the procedure. A folded blanket will be over the patient's hand during the procedure and the anesthesia provider will be next to the patient's hand.

结局指标

主要结局

Iowa Satisfaction with Anesthesia Scale (ISAS)

时间窗: 24 hours after the procedure

11-item questionnaire designed to measure the satisfaction with monitored anesthesia care. The Iowa Satisfaction with Anesthesia Scale (ISAS) score is the mean of responses to all 11questions. The score can range from a min of -3 to a maximum of +3. The responses are : -3 = disagree very much, -2 = disagree moderately, -1 = disagree slightly, 1 = agree slightly, 2 = agree moderately, and 3 = agree very much. A score of +3 would imply a totally satisfied patient.

次要结局

  • State Trait Anxiety Inventory (STAI)(Before and 24 hours after the procedure)
  • Pain Score(Through study completion up to 24 hours after procedure.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验