Actively Recruiting

Phase Not Applicable
Age: 18Years - 35Years
FEMALE
NCT06996340

White Noise and In-vitro Fertilizasyon

Led by Yasemin Sökmen · Updated on 2025-05-30

94

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

Sponsors

Y

Yasemin Sökmen

Lead Sponsor

T

The Scientific and Technological Research Council of Turkey

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

White Noise and In-vitro Fertilizasyon

Who Can Participate

Age: 18Years - 35Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Women between the ages of 18-35
  • Diagnosed with primary infertility
  • Not diagnosed with a psychiatric disease
  • Able to speak and understand Turkish
  • At least primary school graduates
Not Eligible

You will not qualify if you...

  • Women who have undergone oocyte pick-up within the last month
  • Women who have undergone intrauterine insemination within the last month
  • Women who have undergone embryo transfer within the last month
  • Women who have undergone any pharmacological or non-pharmacological application that may reduce stress within the last month

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye), 00550

Actively Recruiting

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Research Team

Y

Yasemin Sökmen, Asistant professor

CONTACT

Ş

Şevval Eda KAYA, Expert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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