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临床试验/NCT05192330
NCT05192330已完成不适用

The Effect of Virtual Reality Glasses Use and Therapeutic Touch on Pain, Anxiety and Patient Satisfaction in Women During Intrauterine Insemination Procedure: A Randomized Controlled Study

Ondokuz Mayıs University2 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2022年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
96
试验地点
2
主要终点
Visual Analog Scale for pain intensity

研究概览

简要总结

This study investigates the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure

详细描述

Infertility treatment is a stressful and anxious process that begins when couples are diagnosed with infertility. Infertility treatment is a process that requires the active participation of couples against emotional and physical difficulties. In addition to intensive routine and surgical procedures, the treatment process is a period in which couples should be in constant communication with healthcare professionals. In Turkey, it is estimated that 10-20% of the couples are diagnosed with infertility. In the evaluation of infertile couples,Intrauterine Insemination is a simple, safe, and minimally invasive procedure to the process of injecting washed sperm into the uterine cavity close to ovulation. Sperm cells taken from men are injected directly into the uterus and left at a point closer to the fertilization point. The aim of this study is to investigate the effect of virtual reality glasses use and therapeutic touch on pain, anxiety and patient satisfaction in women during intrauterine insemination procedure.

This randomized controlled study will conduct at Ondokuz Mayis University Training and Research Hospital, Infertility polyclinic between january 2022 and June 2022.

Volunteer women undergoing Intrauterine Insemination will be include. Participants will randomly assigned to the intervention or the control group using a computer-generated list. A data collection form including socio-demographic and obstetric characteristics such as age, educational status, duration of infertility, previous pregnancies, births, abortion/curettage numbers, Spielberger State Anxiety Scale and Visual Analog Scale scores will use for each patient. After obtaining written informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale (pain and nursing satisfaction) were applied to both groups by face to face interview during the day giving appointment for Intrauterine Insemination. Immediately after the questionnaires will apply, the nurse gave virtual reality glasses. and glasses will be put on before the process starts and training will be given to continue watching the video while wearing the glasses for 30 minutes. Second group participants the nurse researcher will start the application by taking an appropriate hand of the patient between his hands and hold it for 30 minutes.

Participant in the control group received standard care (verbal information about procedure and a short written information about the procedure) and no intervention (virtual reality or therapeutic touch) was performed.The IBM SPSS (Statistical package for the Social Sciences) 23.0 package program was used to evaluate the data obtained in the study.

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 (Participant)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • being diagnosed with infertility over 18 years, being able to understand, read and write in Turkish, wanting to participate in the study,

排除标准

  • not wanting to be included in the study not accepting Therapeutic Touch or Virtual reality glasses not knowing Turkish not wanting to be included in the study

结局指标

主要结局

Visual Analog Scale for pain intensity

时间窗: 10 minutes

After completing the Intrauterine Insemination Procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). A standard ten-point visual analogue scale (VAS) of 0 to 10 was designed and used to assess the patients' perceptions of discomfort during the procedure. A high score on the scale indicated a high level of discomfort and a score of 0 denoted no discomfort at all. Patients indicate the degree of pain they feel between 0-10.

Visual Analog Scale for patient satifaction

时间窗: 10 minutess

Satisfaction level was measured using the visual analog scale (VAS). VAS is used to convert some numerically unmeasured values to numeric values. VAS is a continuous scale that comprises a horizontal line or a vertical line, usually 10 cm (100 mm) in length. On one end of the scale is the statement, "I am not satisfied at all" (zero points), whereas the statement at the other end is "very satisfied." Patients were asked to mark their satisfaction levels on this scale of 100 mm.

Spielberger State Anxiety Scale

时间窗: 30 minutes

After completing the Intrauterine Insemination Procedure, participants filled out the Spielberger State Anxiety Scale. The inventory was developed by Spielberger, Gorsuch, and Lushene in 1970. An adaptation, validity, and reliability study of the State-Trait Anxiety Scale in Turkish was conducted by Oner and Le Compte in 1983. The scale consists of two subdimensions: the state anxiety has 20 items and is used to determine what is felt at a specific moment under certain conditions, and the trait anxiety has 20 items and is used to determine what has been felt in the last 7 days. High scores from each subscale indicate a high level of anxiety.

次要结局

未报告次要终点

研究者

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

Sümeyye BAL

Lecturer

Ondokuz Mayıs University

研究点 (2)

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