The Effects of Glass Waterfall and White Noise on Pain, Anxiety and Physiological Parameters During Gastroscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 156
- 主要终点
- State and Trait Anxiety Scale (STAI)
研究概览
简要总结
Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.
Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who applied to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and were scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis was performed and it was found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group.
详细描述
Background: Gastroscopy is an endoscopic procedure that allows examination of the upper gastrointestinal system, including the esophagus, stomach and duodenum. The procedure is a difficult and stressful diagnosis and treatment method for the patient. Problems such as stress, fear and pain experienced during endoscopy cause anxiety.
Purpose: To examine effects of glass waterfall and white noise on pain, anxiety and physiological parameters during gastroscopy Method: The population of the study consists of all patients who will apply to Mardin Education and Research Hospital, Department of General Surgery, Endoscopy Unit and will be scheduled for gastroscopy. The sample will be represented by 156 patients whose gastroscopy procedure is planned between the specified dates and who meet the criteria for inclusion in the sample. In calculating the sample of the study, power analysis will be performed and it is found the effect size of 1.16, 95% power and 0.05% margin of error for this study, that a total of 156 individuals for the three groups and at 52 individuals for each group. Before gastroscopy procedure, the patients included in the study will be randomly divided into three groups: 52 glass waterfall group, 52 white noise group and 52 control group.
Data will be collected in the endoscopy unit on weekdays when the procedure is performed. All participants in the study will first fill out a patient identification form containing patient demographic information.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 aged and over
- •Written and verbal consent to participate in the study,
- •Being conscious (person, place and time orientation),
- •Undergoing gastroscopy for the first time
排除标准
- •Having vision, hearing and communication problems
- •Having any psychiatric and cognitive/mental mental health problems, disease (dementia, etc.),
- •Diagnosed with visual, auditory and / or balance disorders,
结局指标
主要结局
State and Trait Anxiety Scale (STAI)
时间窗: Change from Baseline The State and Trait Anxiety Scale in 50 minutes
It is a self-assessment questionnaire developed by Spielberger et al. and consists of short assessments. The STAI includes 40 four-point Likert-type items ranging from "None" to "Completely". The validity and reliability of the STAI in Turkey were established by Öner and Le Compte. The STAI includes two separate scales, the State Anxiety Score (SAS) and the Trait Anxiety Score (TAS). The SAS requires the person to describe how they feel at a certain moment and under certain conditions and to respond by taking into account their feelings about the situation they are in. Higher scores indicate increased anxiety level. In the Turkish validity and reliability study, Cronbach's alpha reliability coefficients were between 0.83 and 0.87 for the TAS and between 0.94 and 0.96 for the SAS.
Pulse rate before and after gatroscopy procedure
时间窗: Change from Baseline Pulse rate in 50 minutes
60 to 100 beats per minute is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Visual Analogue Scale (VAS)
时间窗: Change from Baseline Visual Analogue Scale in 50 minutes
This scale developed by Price (1983) will be used in the research to determine the level of tolerance, comfort and satisfaction. It is a scale in which the distance between the two ends with a minimum value of 0 on one end and a maximum value of 10 on the other end is measured with a 10 cm ruler. In this context; The patient is explained that there are two endpoints and that he is free to mark any place between them that fits the severity of his pain. The distance between the beginning of "no comfort, tolerance and satisfaction" and this point marked by the patient is measured and recorded in centimeters. It has been shown that the VAS is a valid tool for the measurement of psychological and health variables such as pain and satisfaction, which is widely used in clinical studies
The Patient Observation Form
时间窗: Change from Baseline The Patient Observation Form in 50 minutes
This form will be created by the researcher based on the literature review, the physiological parameters (pulse (min), respiratory rate (min), systolic blood pressure (mmHg), diastolic blood pressure (mmHg), and oxygen saturation values (%)) of the patients before and after the procedure will be recorded the form. Researcher will has a automatic blood pressure monitor and a probe device for recording the variables in the endoscopy unit. While the patients' physiological parameters will being taken, a fully automatic blood pressure monitor will be used to measure blood pressure and pulse. To measure the respiratory rate, the patient placed his hand on his chest and his chest movements will be counted and recorded for one minute. Oxygen saturation level will be measured from the index finger with a probe device. Data will be collected by recording all parameters measurement values on a single form. The form will similar to forms commonly used in nursing research.
Patient Information Form
时间窗: the fundamental characteristics of the patients will be filled in 15 minutes before the gastroscopy procedure
This form, which will be created by the researcher; Patients' age, gender, education level, marital status, employment status, income level, chronic disease status, previous surgery, complaints about coming to the hospital, whether they would prefer the current method if they need to have gastroscopy again, It consists of a total of 10 questions.
Respiratory rate before and after gatroscopy procedure
时间窗: Change from Baseline Respiratory rate in 50 minutes
12 to 18 breaths per minute is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Systolic and diastolic blood pressure before and after gatroscopy procedure
时间窗: Change from Baseline Systolic and diastolic blood pressure in 50 minutes
90/60 mm Hg to 120/80 mm Hg is normal. It will be recorded 15 minutes before and after the gastroscopy procedure
Oxygen saturation values before and after gatroscopy procedure
时间窗: Change from Baseline Oxygen saturation values in 50 minutes
Normal oxygen saturation usually ranges from 95 to 100%. It will be recorded 15 minutes before and after the gastroscopy procedure
次要结局
未报告次要终点
研究者
Hasan Genç
Asistant Professor
Dicle University