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临床试验/NCT06110871
NCT06110871招募中不适用

"The Effect of Inhaler Lavender, Focus and Music on Women's Pain, Anxiety, in Intrauterine Device Application"

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2023年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
240
试验地点
2
主要终点
The Verbal Category Scale

研究概览

简要总结

Randomized control is an experimental study. The purpose of this research; To examine the effects of inhaler lavender, focus and music on women's pain and anxi.ety in intrauterine device application.

In the randomized controlled experimental study, data would be obtained using the Numerical Anxiety Rating Scale and the Numerical Pain Rating Scale. 240 women who underwent IUD procedure at the Family Planning Consultancy Polyclinic of a secondary level public hospital in a city center between October and December 2023 were randomly assigned to receive 4 sets of 1 set of Inhaled lavender (60), 1 set of Focusing (60), 1 set of Music ( 60). 1 control group (60) will participate in the study.

详细描述

The rate of women who want to use Family Planning in the world has reached approximately 1.1 billion in the last twenty years and has shown a significant increase ( WHO, 2020) . In addition, WHO reported that almost half of the pregnancies in developing countries between 2015 and 2019 were unwanted pregnancies (WHO, 2020) , and recommended effective FP counseling and the use of more modern contraceptive methods to prevent this (WHO, 2020) . In Turkey, the Ministry of Health provides individuals with free access to modern FP methods. Despite this, according to the 2018 data of the Turkey Demographic and Health Survey ( Akdemir and Karadeniz 2019), it has been reported that 49% of the FP method uses modern methods and the Intrauterine Device (IUD) is among the most effective modern methods with a rate of 14% (Akdemir and Karadeniz 2019 ). Factors affecting IUD use include; Women's perception of pain during application and the fact that it can be applied in certain centers (Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018).

It has been reported in the literature that women perceive pain during IUD application (Akdemir and Karadeniz 2019; Dine et al,2018; Hunter et al, 2020; Hamdamian et al., 2018). Again, studies have reported the use of inhaled lavender, focus, and music to relieve pain and anxiety (Hamdamian et al., 2018; Hathcock et al., 2021; Türkmen et al.,2021) . These results emphasize the need for low-cost and applicable nonpharmacological methods for healthcare professionals during IUD insertion.

No study has been found in the literature examining the effects of inhaler lavender, focus and music on women's pain and anxiety during intrauterine device application. However, in line with the results of the study, it is thought that it will have a positive effect on reducing the pain and anxiety perceived by women during the IUD procedure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

盲法说明

PERSON USING IUD. IT WILL ALWAYS BE THE SAME AND THERE WILL BE ONE PERSON WHO HAS NOTHING TO DO WITH THE RESEARCH.

THE RESEARCHER WILL HAVE NO INTERVENTION DURING IUD APPLICATION.

入排标准

性别
Female
接受健康志愿者

入选标准

  • Being between the ages of 18-45,
  • having IUD applied for the first time,
  • being literate in Turkish,
  • having no history of cervical surgery,
  • having no active mental illness,
  • having no pain before IUD application.

排除标准

  • Having communication problems,
  • visual or auditory disabilities,
  • use of misoprostol during the procedure,
  • use of painkillers before the IUD application procedure,
  • use of medication for anxiety before the procedure.

结局指标

主要结局

The Verbal Category Scale

时间窗: 15 minutes after the Pap smear test.

The Verbal Category Scale is also called the Simple Descriptive Scale, and this scale is based on the patient choosing the most appropriate word that describes the pain condition. Pain intensity ranges from mild to unbearable. In this scale, the words "mild", "disturbing", "severe", "very severe", "unbearable" were used to describe the intensity of pain (

Numerical Pain Rating Scale Pain

时间窗: 15 minutes after the Pap smear test.

Numerical Pain Assessment Scale Pain (NADÖ): Numerical Pain Assessment Scale (NADÖ) is used to evaluate the severity of pain. On the numerical rating scale, pain ranges from 0 (absence of pain) to 10 (unbearable pain).

Numerical Rating Scale for Anxiety (VASA).

时间窗: 2 minutes

Numerical Rating Scale for Anxiety (VASA). It is expressed a Outcome 8s whether the individual feels anxiety (e.g., I have a lot of anxiety = 10) or does not feel anxiety (e.g., I have no anxiety = 0).

次要结局

未报告次要终点

研究者

发起方
Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Mine Gokduman Keles

Midwifery

Turkish Ministry of Health, Kahramanmaras Provincial Health Directorate

研究点 (2)

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