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临床试验/NCT06651320
NCT06651320尚未招募不适用

Effect of Preoperative Patient Education Via Animated Videos in Patients Undergoing Operative Hysteroscopy Under Anesthesia

Assaf-Harofeh Medical Center1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
1
主要终点
Number of patients who experienced anxiety before the procedure as assessed by STAI-S

研究概览

简要总结

The goal of this clinical trial is to assess if the use of an audiovisual animated video, describing the gynecological procedure (hysteroscopy) the patient is about to undergo, will help to reduce the patient's level of anxiety, affect her anesthesia parameters and increase their overall satisfaction from the procedure.

Our hypothesis is that patient who will watch the video (intervention group) will experience less anxiety, will have lower heart rate and lower blood pressure during the procedure, and have overall more satisfaction with the procedure, compared to patients who will not watch the preoperative video (control group).

Patients will be asked to rate their anxiety level before the procedure and their satisfaction afterwards.

详细描述

Is has been questioned what the effectiveness of various modes of delivering preoperative education in reducing preoperative anxiety is and as a result pain and overall satisfaction of patients from surgical producers. It is known that women undergoing hysteroscopy suffer from significant levels of anxiety, with repercussions on pain perception, success rates and satisfaction (1). In the inpatient surgery setting, preoperative anxiety is commonly managed by means of pharmacological interventions such as the use of anxiolytics and sedatives. Communication and patient education have been proved as effective tools to reduce preoperative anxiety, and their role should be increasingly acknowledged, now that many patients are active consumers of unfiltered and largely unreliable information through the Internet.

One meta-analysis which included 14 interventional trials (1) concluded that preoperative education interventions are promising in reducing preoperative anxiety in patients scheduled for surgical procedures (1).

Objective To assess if the use of an audiovisual animated video describing the gynecological procedure (hysteroscopy) the patient is about to undergo will help to reduce the patient's level of anxiety, affect her anesthesia parameters and increase their overall satisfaction from the procedure.

Design A randomized control trial including the patients undergoing operative hysteroscopy under anesthesia in the operation room via the endoscopy unit's team, Shamir hospital, Israel.

Inclusion criteria: adult patients (above 18 and older), undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.

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 —(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Adult patients (above 18 and older),
  • •Patients undergoing operative hysteroscopy under anesthesia in our OR due to uterine findings previously diagnosed during diagnostic hysteroscopy.

排除标准

  • •Patients who are not able to watch the audiovisual video
  • •Patients who cannot sign a consent form.

研究组 & 干预措施

1 Intervention group: traditional patient education (nurse + physician pre-procedural counseling) +

Experimental

intervention

干预措施: The patients in the interventional arm will be introduced to video will be introduced to a concise, animated video explaining the steps they are about to undergo in the department, the OR, recovery (Other)

2 The Nonintervention group would receive the traditional patient education before the procedure (vi

No Intervention

结局指标

主要结局

Number of patients who experienced anxiety before the procedure as assessed by STAI-S

时间窗: From the enrollment to the beginning of general anesthesia, up to 48 hours

次要结局

  • Heart rate (bpm)(During the procedure, up to 120 minutes)
  • Blood pressure (mmHg)(During the procedure, up to 120 minutes)

研究者

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

Matan Mor

Attending physician - Minimal Invasive Gynecology Unit, Shamir Medical Center

Assaf-Harofeh Medical Center

研究点 (1)

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