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临床试验/NCT06996340
NCT06996340招募中不适用

Effects of White Noise on Pain, Anxiety and Comfort During in Invitro Fertilization: a Randomized Controlled Trial

Yasemin Sökmen1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年3月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
94
试验地点
1
主要终点
Anxiety

研究概览

简要总结

In vitro fertilization is the placement of embryos into the uterus with a catheter under ultrasound guidance after the fertilization of sperm and oocytes in a laboratory tube. In the literature, various nonpharmacological methods such as acupuncture, yoga, meditation, deep breathing exercises, massage, art therapy and mind/body therapy have been used to cope with stress, pain and anxiety in infertile women. However, no study has been found examining the effect of white noise during in vitro fertilization. The aim of this study is to determine the effect of white noise on pain, anxiety and comfort during in vitro fertilization. This research is a randomized controlled experimental study. The universe of the study will consist of women coming to the in vitro fertilization center at Ondokuz Mayıs University Health Application and Research Center. The sample size of the study was calculated using the G*Power 3.1. 9.2 program, taking into account the data of the study by Fleury et al (2021). The post-procedure stress mean and standard deviation values of the experimental and control groups of the relevant study were used to calculate the effect size as 0.75. The minimum number of individuals to be included in the sample of this study was calculated using G*Power 3.1. 9.2 as effect size: 0.75, α= 0.05, power: 0.95, and the sample size was determined as 94 women (experimental group: 47, control group: 47). The data of the study will be collected with the Introduction Form, Visual Analog Scale, Anxiety Rating Scale, and General Comfort Scale Short Form. The data of the study will be evaluated using the SPSS 24 deviation, median and minimum-maximum values will be given. Chi-square test, Student t test, ANOVA test for those with normal distribution, Mann-Whitney U and Kruskal Wallis tests for those who are not.

详细描述

Assisted reproductive techniques are interventions that involve the in vitro processing of human oocytes, sperm or embryos for reproductive purposes (Zegers-Hochschild et al., 2017). In these interventions, various procedures such as ovarian stimulation, oocyte collection and embryo placement in the uterus are performed (Zhang et al., 2022). The most advanced and frequently used method of these procedures is in vitro fertilization. In in vitro fertilization, after the fertilization of sperm and oocyte in a tube in a laboratory environment, the resulting embryos are placed in the uterus with a catheter under ultrasound guidance (Çavuşoğlu, 2017). It has been reported that approximately 8 million children have been born since the initiation of procedures such as in vitro fertilization in the world (Fauser, 2019). Infertility is an important crisis in the lives of couples as it affects individuals physically, psychologically, emotionally, sexually and socially (Assaysh-Öberg et al, 2023; Kırca and Pasinlioğlu, 2019; Oh et al, 2024; Öztürk et al, 2020; Rooney and Domar, 2018). Because painful invasive procedures and interventions for diagnosis, uncertainty about the cause of infertility, lack of information about the treatment process, high cost of treatment, negative outcomes and social pressure lead to psychological problems in infertile individuals (Martínez-Pampliega et al, 2019; Oh et al, 2024; Öztürk et al, 2020; Rooney and Domar, 2018). The most common psychological problems are stress, anxiety and depression, and women experience stress before, during and after treatment (Kim et al, 2020; Kirca and Pasinlioglu, 2019; Rooney and Domar, 2018). The stress experienced both reduces the effectiveness of infertility treatment and causes treatment discontinuation (Kirca and Pasinlioglu, 2019; Rooney and Domar, 2018). In a study conducted on infertile women in Romania, it was reported that 63% of infertile women experienced stress during assisted reproductive treatment (Margan et al, 2022). Again, in a study examining the effect of stress on assisted reproductive treatment outcomes in infertile women in Tunisia, it was stated that women were much more stressed on the day of embryo transfer, and that primary infertile women had significantly higher stress levels than secondary infertile women (Sallem et al, 2021). There is a bidirectional and complex relationship between infertility and stress (Boivin, 2019). In addition, invasive procedures performed during the infertility diagnosis and treatment process cause pain, while the thought of whether the treatment will be successful or not causes stress (Assaysh-Öberg et al., 2023; de Boer et al., 2020). Health professionals need to support infertile women in coping with stress in order to reduce their stress levels (Rooney and Domar, 2018). When the studies in the literature are examined, different non-pharmacological methods such as acupuncture, yoga, meditation, deep breathing exercises, massage, art therapy and mind/body therapy have been used in infertile women to cope with stress (Akimbekov and Razzaque, 2021; Sis Çelik and Kırca, 2018; Gönül and Arslan, 2019; Kırca and Pasinlioğlu, 2019; Meier et al., 2021; Rooney and Domar, 2018). However, no study has been found examining the effect of white noise during in vitro fertilization. White noise is a continuous monotonous sound such as wind, waterfall, ocean waves or rain in the environment, and is a sound obtained by mixing equal amounts of different frequency sounds in a laboratory environment and preparing them in a digital environment and calibrating all of its frequencies (Cho and Hwang, 2021; Lin et al, 2018). Therefore, it was decided to conduct this study. The aim of this study is to determine the effect of white noise on pain, anxiety and comfort during in vitro fertilization.

Research Hypothesis; H01: There is no difference in pain between the white noise and control groups. H02: There is no difference in anxiety between the white noise and control groups.

H03: There is no difference in comfort between the white noise and control groups.

MATERIAL AND METHODS

Research Method

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)

盲法说明

White noise group: The woman who was taken to the gynecological table for invirto fertilization will be made to listen to white noise (rain and waterfall sound) with a Bluetooth headset at a range of 75-85 decibels during the procedure. Because, it covers all sound ranges that people can hear within the range of 75-85 decibels (Cho and Hwang, 2021; Lin et al, 2018).

Control group: The woman who was taken to the gynecological table for invirto fertilization was left to routine during the procedure.

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •Women between the ages of 18-35,
  • •Diagnosed with primary infertility,
  • •Not diagnosed with a psychiatric disease,
  • •Who can speak and understand Turkish,
  • •Who are at least primary school graduates will be included in the study

排除标准

  • •Women who have undergone oocyte pick-up within the last month,
  • •Who have undergone intrauterine insemination within the last month,
  • •Who have undergone embryo transfer within the last month,
  • •Who have undergone any other pharmacological or non-pharmacological application that may reduce stress will be excluded.

研究组 & 干预措施

White noise group:

Experimental

The woman who was taken to the gynecological table for invirto fertilization will be made to listen to white noise (rain and waterfall sound) with a Bluetooth headset at a range of 75-85 decibels during the procedure. Because, it covers all sound ranges that people can hear within the range of 75-85 decibels (Cho and Hwang, 2021; Lin et al, 2018).

干预措施: White noise group (Other)

Control group:

Other

The woman who was taken to the gynecological table for invirto fertilization was left to routine during the procedure.

干预措施: routine care (Other)

结局指标

主要结局

Anxiety

时间窗: 30 minutes before in vitro fertilization

Will be evaluated with the Anxiety Assessment Scale.

Pain

时间窗: 30 minutes before in vitro fertilization

Pain will be assessed with the Visual Analog Scale before and after the procedure.

Comfort

时间窗: 30 minutes before in vitro fertilization

It will be evaluated with the General Comfort Scale Short Form.

次要结局

  • Pain(30 minutes after in vitro fertilization)
  • Anxiety(30 minutes after in vitro fertilization)
  • Comfort(30 minutes after in vitro fertilization)

研究者

发起方
Yasemin Sökmen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yasemin Sökmen

Asistant Professor

Ondokuz Mayıs University

研究点 (1)

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