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临床试验/NCT04676932
NCT04676932已完成不适用

The Effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography

Sümeyye BAL1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2020年9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
发起方
入组人数
126
试验地点
1
主要终点
Visual Analog Scale(VAS)

研究概览

简要总结

Hysterosalpingography (HSG) is the radiological evaluation of the uterine cavity and tubules by giving radiopaque material from the cervical canal to the uterine cavity. HSG is an invasive procedure and is often described by women as "uncomfortable, anxiety-inducing and painful", which indicates impaired comfort .Physical, emotional, sociocultural and environmental factors contribute to the formation of this condition. Comfort Theory is a nursing model that makes it easier for the caregivers to see their problems more systematically and to plan more easily. In the literature review, no studies have been found to determine the effect of Nursing Care Based on Kolcaba's Comfort Theory in Reducing Pain and Comfort on Women Undergoing Hysterosalpingography. It was aimed to determine the effect of Nursing Care Based on Kolcaba Comfort Theory on Pain and Comfort Level in Women Undergoing Hysterosalpingography Procedure.

Method. The universe of the research will form women applying for hysterosalpingography procedure in Turkey's northern province of the Health Research and Application Center between. The sample size to be taken from the universe was determined by power analysis based on the reference values of a similar study in the literature. According to the Power analysis, it was decided to include a total of 126 women, including 42 women, in each group (Control group, Intervention 1: Mobile-assisted education and counseling group, Intervention 2: Virtual reality glasses group). In this study, standard nursing care will be applied to the control group, and nursing care based on Kolcaba's Comfort Theory will be applied to the intervention groups.The data will be collected with the Visual Analog Scale(VAS) and General Comfort Questionnaire (GCQ)

详细描述

In this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG. Before the HSG , the women will be met at the appointment time and the women will be given care during the procedure.Up to 15 minutes after the procedure will be with women. There will be 2 intervention groups and one control group. In the first intervention group, virtual reality glasses will be applied during the procedure, Mobile-assisted education and consultancy will be provided in the 2nd intervention group. This mobile assisted education and consultancy starts 48 hours before HSG shooting.The hsg capture will continue until it ends. Hospital care standards will be applied to the control group, the third group.

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
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

participant women, care provider and Outcomes Assessor

入排标准

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

入选标准

  • •Volunteering to participate in research
  • •Being over 18 years old
  • •To be at least a primary school graduate
  • •To be able to read and write Turkish
  • •Not having a diagnosed psychiatric disease
  • •No mental deficiency and communication problems.
  • •Drug sensitivity and lack of allergy
  • •Regular menstrual cycle
  • •Getting a diagnosis of primary infertility
  • •Not having received infertility treatment before
  • •Having a mobile phone capable of receiving and playing video messages

排除标准

  • •Being illiterate
  • •Being under the age of 18
  • •Having a diagnosed psychiatric illness
  • •Having mental deficiency and communication problems
  • •Finding drug sensitivity and allergy
  • •Diagnosing secondary infertility
  • •Having an active genital infection
  • •The absence of a mobile phone with the ability to receive and play video messages

研究组 & 干预措施

Routine hospital schedule

No Intervention

The researcher sincerely answered all questions asked by the control group during the HSG period.

Nursing Care Based on Kolcaba's Comfort Theory

Experimental

In this study, nursing care based on Kolcaba's Comfort Theory will be applied to the intervention groups.

Care will given when women after receiving the HSG attendance appointment. Care will terminated on the 15 minutes after the end of HSG undergoing.

The time of the study 1-3 days for each women. Intervention Nursing Care Based on Kolcaba's Comfort Theory

干预措施: Nursing Care Based on Kolcaba's Comfort Theory (Other)

结局指标

主要结局

Visual Analog Scale(VAS)

时间窗: 10 minutes

After completing the HSG procedure, participants were asked to evaluate their pain in order to characterize pain intensity using the Visual Analog Scale (VAS). Patients indicated the maximum pain intensity experienced during the HSG by making a vertical line on the 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.

General Comfort Questionaire (GCQ)

时间窗: 30 minutes

The scale, which was developed by Katharine Kolcaba in 1992 in order to determine the comfort needs of individuals, to evaluate the nursing initiatives that can provide comfort and the increase in comfort, was adapted to Turkish society by Kuğuoğlu and Karabacak in 2004.The scale, which is a four-point Likert-type scale with 48 items, was created by guiding the taxonomic structure consisting of the theoretical components of comfort, including 3 levels and 4 dimensions. Level; While the dimension is evaluated as relief (16 items), relief (17 items) and overcoming the problems (15 items); It is evaluated in three parts: physical (12 items), psychospritual (13 items) and socio-cultural (10 items). Negative expressions in the scale are calculated by reverse coding during the evaluation phase. While the lowest total score that can be obtained from the scale is 48, the highest total score is 192.

次要结局

未报告次要终点

研究者

发起方
Sümeyye BAL
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sümeyye BAL

Lecturer

Ondokuz Mayıs University

研究点 (1)

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