RecruitingNot ApplicableNCT06996340

White Noise and In-vitro Fertilizasyon

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


Sponsor

Yasemin Sökmen

Enrollment

94 participants

Start Date

Mar 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 35 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether playing white noise — a calming background sound — during an IVF (in vitro fertilization) embryo transfer procedure can help reduce stress and anxiety in women undergoing fertility treatment. High anxiety during IVF is common, and reducing it during the procedure may improve the experience and potentially support better outcomes. This is a simple, non-invasive intervention being studied in a clinical IVF setting in Turkey. **You may be eligible if...** - You are a woman between 18 and 35 years old - You have been diagnosed with primary infertility (have never been pregnant before) - You do not have a diagnosed psychiatric illness - You speak and understand Turkish - You have completed at least a primary school education **You may NOT be eligible if...** - You had an egg retrieval, intrauterine insemination, or embryo transfer in the past month - You recently received any other pharmacological or non-pharmacological stress-reduction treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERWhite 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).

OTHERroutine care

routine care


Locations(1)

Ondokuz Mayıs University

Samsun, Atakum, Turkey (Türkiye)

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NCT06996340