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临床试验/NCT05496647
NCT05496647已完成不适用

The Effect Of Vırtual Realıty, Musıc Therapy, And Stress Ball Applıcatıon On Paın And Anxıety Durıng Daıly Gynecologıcal Surgery

Marmara University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2022年6月15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
入组人数
160
试验地点
1
主要终点
Pain Severity

研究概览

简要总结

Outpatient surgical interventions; It is defined as surgical applications where the application time is short, the risk of complications is low, there is no need for intensive care after the intervention, and the patients can be discharged on the same day. It is applied in areas such as otolaryngology and maxillofacial surgery. Among all these areas, gynecological surgery is the area where the most outpatient surgery is performed. Some of the gynecological procedures that are generally applied in day surgery are as follows; Colposcopy, hysteroscopy, laparoscopy, dilatation-curettage, laparoscopic tubal ligation, treatment of the cervix with cautery or laser, removal of vulvar cysts, laser conization, cervical polypectomy and removal of Bartholin cysts.

In many state hospitals in our country, in daily gynecological surgical procedures; in some cases by premedication, in some cases under local anesthesia; however, patients are usually processed without anesthesia.

Virtual Reality, which is a type of computer system using human-machine interfaces, has been used in pain and anxiety management in different applications in many areas known as painful medical procedures in recent years.

Music therapy is defined as "the systematic use of music in a therapeutic relationship aimed at improving, maintaining and advancing emotional, physical and mental health". Music therapy has important physiological effects that reduce heart rate, blood pressure, body temperature, and respiratory rate, distract attention, increase the quality of life of patients, and reduce pain.

Stress ball emerges as a simple, reliable, inexpensive, and easily accessible method that helps patients reduce their anxiety. Squeezing the stress ball during the surgical procedure allows patients to have direct control over the object, increasing feelings of empowerment. In this way, it has a positive effect on anxiety and patient satisfaction without interfering with the surgical procedure. Based on all these reasons; The aim of this study is to determine the effects of virtual reality, music therapy, and stress ball applications on vital signs, pain, anxiety, and patient satisfaction during daily gynecological surgery.

详细描述

Virtual Reality

Virtual Reality (VR) is a term formed from the words virtual and reality. According to the Turkish Language Association; Virtuality, which means unreal, or hypothetical, derives from the Latin word "virtual". The reality is; the real is defined as the whole of the things that exist and the truth. Virtual reality, which emerged as a concept in the 1950s, started to be used in application areas in the 1900s.

Virtual reality, which has been used only for space and military research as a computer-based, high-cost technology for years, has recently become widespread in the fields of medicine, education, entertainment, librarianship, museology, architecture, and industrial design with different applications developed for mobile devices.

Today, common and easily accessible android-based smart devices capable of running virtual reality are used. The image is obtained using a combination of framed simple optical lenses that hold the phone at a fixed distance perpendicular to the user's gaze direction. The working system of three-dimensional resuscitation devices is based on stereographic vision properties. After the relevant applications are installed on the smartphone, the device divides the screen into two, and thanks to the acquisition of different images for the right and left eyes, the illusion of the spatial existence of three-dimensional animated objects is obtained.

Virtual Reality is a simulation model that gives a sense of reality to its participants, is created based on computers, and allows mutual communication.

研究设计

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

盲法说明

Criteria for Inclusion in the Research

  • Over 18 years old,
  • Can speak Turkish,
  • Subjected to daily gynecological surgery for the first time,
  • Does not have any psychiatric disease and mental perception problems,
  • Having no vision, hearing, and perception problems,
  • Having no physical problems squeezing a stress ball,
  • There will be women who agree to participate in the research verbally and in writing.

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

  • •Over 18 years old,
  • •Can speak Turkish,
  • •Subjected to daily gynecological surgery for the first time,
  • •Does not have any psychiatric disease and mental perception problems,
  • •Having no vision, hearing, and perception problems,
  • •Having no physical problems squeezing a stress ball,
  • •There will be women who agree to participate in the research verbally and in writing.

排除标准

  • •Having used analgesic or anesthetic drugs within 24 hours before or during the procedure
  • •Using antidepressant, anxiolytic and sedative drugs
  • •Communication difficulties and mental disability
  • •Patients with severe vision and hearing problems, and physical disabilities (with open wounds on their hands, insufficient muscle strength to squeeze a stress ball) will not be included in the study.

研究组 & 干预措施

Virtual Reality (VR)

Experimental

Virtual Reality Application (VR) VR group patients will be shown VR videos that include landscapes such as nature and the sea, giving people a feeling of comfort and peace, and making them feel like they are inside. During the surgical procedure, VR videos will be watched for an average of 20 minutes with X-brand VR glasses. In the research, similar studies will be examined and 360o VR video, which is a licensed product with atmospheric music background, containing relaxing nature images and nature sounds will be used.

干预措施: Virtual Reality (Other)

Music Therapy

Experimental

Music Therapy Application During the surgical procedure, an mp3 player, and music therapy CDs of uşşak and Hüseyni will be used. (Oline will also create a list from music platforms (fizzy-Spotify, etc.)) Before starting the procedure, the patients will be asked about their music preferences and the music will be played to the patients (20 minutes) during the procedure in line with their preferences. Headphones provided by the researcher will be used for patients with headphones, and for patients without headphones.

The music authorities used (hüseyni and uşşak) will be provided and used by order, by obtaining the necessary permissions from the official site of TÜMATA.

干预措施: Music Therapy (Other)

Stress Ball Application

Experimental

Stress Ball Application A sufficient number of stress balls will be provided by the investigator for each patient to use separately before starting the study. Before starting the day-to-day gynecological surgery, patients in the stress ball group will be given a round, colored, medium-hard, compressible Knaftmed ball made of high-quality silicone. To avoid implying that the procedure is inherently stressful, it will be referred to as a squeezing ball when instructing patients about stress ball application.

During the surgical procedure, it will be said that he can squeeze the stress ball as often as he wants for about 20-25 minutes and the stress ball will be given to each patient.

干预措施: Stress Ball Application (Other)

Control

Experimental

During the process; Women in the control group will not undergo any intervention other than routine surgery.

干预措施: Control (Other)

结局指标

主要结局

Pain Severity

时间窗: 5 Months

Fear of Pain Scale-III; Participants mark the option that best describes the severity of their fear according to their pain experiences regarding the items listed on the scale. In the scoring, it means that 1- fear is never heard, and 5-fear is excessive. The lowest score that can be obtained in total is 30, and the highest score is 150.The lowest score that can be obtained for the sub-dimensions is 10, and the highest score is 50. The higher the individual's score on the scale, the higher the fear of pain. Visual Analog Scale = VAS; In order to determine the severity of the pain experienced by the participants during and after the outpatient gynecological surgical procedure, score measurements in centimeters (cm) will be determined on the vertically prepared GCS. Visual Comparison Scale (0cm;No pain, 0.5cm- 3.0cm;Mild pain, 3.5cm-6.5cm;Moderate pain, 7.0cm-10.0cm;Severe pain).

次要结局

  • Patient Satisfaction Evaluation Form(5 Months)
  • Life Information Tracking Form(5 Months)
  • Anxiety Intensity(5 Months)
  • Patient Information Form(5 Months)

研究者

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

Nurdan Demirci

PhD RN, Professor

Marmara University

研究点 (1)

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