White Noise and In-vitro Fertilizasyon

NCT06996340 | Recruiting

• 1 other identifier: B.30.2.ODM.0.20.08/718-772
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

WHITE NOISE, INVITRO FERTILIZATION, PAIN, ANXIETY, COMFORT

Outcome Measures

Primary Outcomes (3)

• Pain

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

  30 minutes before in vitro fertilization

• Anxiety

  Will be evaluated with the Anxiety Assessment Scale.

  30 minutes before in vitro fertilization

• Comfort

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

  30 minutes before in vitro fertilization

Secondary Outcomes (3)

• Pain

  30 minutes after in vitro fertilization

• Anxiety

  30 minutes after in vitro fertilization

• Comfort

  30 minutes after in vitro fertilization

Study Arms (2)

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).

Other: White noise group

Control group:

OTHER

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

Other: routine care

Interventions

White noise group OTHER

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).

White noise group:

routine care OTHER

routine care

Control group:

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Women between the ages of 18-35 will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yasemin Sökmen: lead
• The Scientific and Technological Research Council of Turkey: collaborator

Study Sites (1)

Ondokuz Mayıs University

Samsun, Atakum, 00550, Turkey (Türkiye)

RECRUITING

Related Publications (42)

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  RESULT

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• Fauser BC. Towards the global coverage of a unified registry of IVF outcomes. Reprod Biomed Online. 2019 Feb;38(2):133-137. doi: 10.1016/j.rbmo.2018.12.001. Epub 2018 Dec 14. No abstract available.

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• Fleury EAB, Approbato MS, Barbosa MA. Interactive Music Therapy on Stress Level Reduction in Women Submitted to IVF/ICSI. Prospective Randomized Study. JBRA Assist Reprod. 2021 Apr 27;25(2):209-214. doi: 10.5935/1518-0557.20200068.

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• Gönül, K., Arslan, H., 2019. İnfertilite tedavisi alan çiftlerin kullandıkları tamamlayıcı ve alternatif tıp uygulamaları. Cukurova Medical Journal, 44, 329-338.

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  PMID: 32112629 RESULT

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  PMID: 30657179 RESULT

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MeSH Terms

Conditions

Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Yasemin Sökmen, Asistant professor

  Ondokuz Mayıs University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yasemin Sökmen, Asistant professor

CONTACT

5342595088; ysmn0006@outlook.com

Şevval Eda KAYA, Expert

CONTACT

5511271105; sevval.eda@icloud.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Asistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 21, 2025
• First Posted: May 30, 2025
• Study Start: March 3, 2025
• Primary Completion: June 2, 2025
• Study Completion: June 15, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)