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临床试验/NCT07101172
NCT07101172Enrolling By Invitation不适用

A Simple Approach to Managing Anxiety and Pain During Prostate Biopsy: Effectiveness of Stress Ball Application

Hitit University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年10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
Enrolling By Invitation
发起方
入组人数
66
试验地点
1
主要终点
Personal Information Form

研究概览

简要总结

This study aimed to determine the effectiveness of stress ball application in the management of anxiety and pain during prostate biopsy.

详细描述

The aim of this study was to determine the effectiveness of stress ball application in managing anxiety and pain during prostate biopsy.

This experimental study was performed with experimental-control group (N=66) patients.Data will be collected using the "Personal Information Form", "Visual Analog Scale (VAS)", "State Anxiety Inventory (STAI-S)" and "Patient Follow-up Form".

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
Single (Participant)

入排标准

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

入选标准

  • •Patients who come to the Urology Service for a prostate biopsy, are willing to participate in the study, are over 18 years of age, are conscious, literate, have no visual or hearing impairments, no psychiatric diagnoses or neurological problems, are undergoing a prostate biopsy for the first time, and do not have weakness in their hands or arms to squeeze a ball will be included.

排除标准

  • •Patients who do not volunteer to participate in the study, who wish to withdraw from the study, who are under 18 years of age, who are unconscious, illiterate, visually or hearing impaired, who have a psychiatric diagnosis or neurological problem, who have previously had a prostate biopsy, and who have weakness in the hand or arm for the ability to squeeze a ball will be excluded from the study.

研究组 & 干预措施

control group

No Intervention

Stress Ball

Experimental

干预措施: stress ball (Procedure)

结局指标

主要结局

Personal Information Form

时间窗: 12 months

Personal Information Form : This form, developed by the researcher based on literature, includes the age, education level, marital status, employment status, income level, daily pain coping strategies, stress coping strategies, previous surgery history, and whether patients are aware of prostate biopsy. It consists of nine questions . It will be used to determine the individual characteristics of the patient.

Visual Analog Scale (VAS)

时间窗: 12 months

Visual Analog Scale (VAS) : This scale is used to assess the severity of pain. It is usually a 10 cm long horizontal or vertical line that begins with "No pain" and ends with "Unbearable pain." It will be used to determine the patient's pain intensity.

State Anxiety Inventory (STAI-S)

时间窗: 12 months

State Anxiety Inventory (STAI-S) (Appendix 3): The State Anxiety Inventory has two subscales, each consisting of 20 items. The State Anxiety Inventory (STAI-S) describes how individuals feel under different circumstances and in the moment, while the Trait Anxiety Inventory (STAI-T) describes how they generally feel in their lives. The inventory is a 4-point Likert-type scale, with ratings based on the severity of the emotions and behaviors in the State and Trait Anxiety Subscales. According to the results, average anxiety scores range from 36 to 41, with scores above indicating high anxiety and below indicating low anxiety. It will be used to determine the patient's anxiety level.

Patient Follow-up Form

时间窗: 12 months

Patient Follow-up Form: This is the form created to record the vital signs of the patients \[pulse, respiratory rate, systolic blood pressure (SBP), diastolic blood pressure (DBP) and oxygen saturation values (SpO2)) measured by the researcher before and after the procedure. It will be used to monitor and evaluate the patient's vital signs.

次要结局

未报告次要终点

研究者

发起方
Hitit University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zehra UNAL

assistant professor

Hitit University

研究点 (1)

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