NCT07575594

Brief Summary

Childbirth is defined as the process in which the fetus and its appendages are expelled from the uterus. The World Health Organization emphasizes that women should have a positive childbirth experience and recommends interventions that reduce pain and stress while increasing maternal satisfaction. White noise, defined as continuous and monotonous sounds such as wave, water, or wind sounds, and quiet time, described as periods in which environmental noise is minimized, have been shown to reduce pain and stress and improve satisfaction in various patient groups. However, there is a lack of evidence regarding their effects during labor. Therefore, this study was planned to evaluate the effects of white noise and quiet time interventions applied during labor on perceived labor pain, stress levels, and childbirth satisfaction.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
159

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 10, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 11, 2026

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

5 months

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Quiet timeWhite noisebirth

Outcome Measures

Primary Outcomes (1)

  • Pain level during labor

    Labor pain levels will be assessed using the Visual Analog Scale (VAS). Measurements will be performed during the latent and active phases of labor at specific cervical dilation stages (4-10 cm).

    During labor, between 4-10 cm cervical dilation (latent and active phases)

Study Arms (3)

White Noise Group

Participants received white noise via Bluetooth headphones during active labor at 6 cm and 8 cm cervical dilation (15 minutes each, 50-65 dB). Pain and stress were assessed using VAS, and maternal satisfaction was evaluated postpartum.

Behavioral: White Noise Exposure

Quiet Time Group

At the beginning of the active phase (when cervical dilation was 4 cm), the participant was informed about the study and informed consent was obtained. The Demographic Information Form was completed, and pain was assessed using the Visual Analogue Scale (VAS), while stress was evaluated using a Visual Analogue Scale (VAS). Routine monitoring and standard care were provided. At 6 cm cervical dilation during the active phase, quiet time was provided for 15 minutes using Polter headphones. Routine monitoring and standard care were continued. At 8 cm cervical dilation during the active phase, quiet time was again provided for 15 minutes using Polter headphones. Routine monitoring and standard care were continued. After the intervention, pain was assessed using the Visual Analogue Scale (VAS), and stress was evaluated using a Visual Analogue Scale (VAS). At the second hour postpartum, the Maternal Satisfaction in Childbirth Scale was completed.

Behavioral: Quiet Time Intervention

Control Group

At the beginning of the active phase (when cervical dilation was 4 cm), the participant was informed about the study and informed consent was obtained. The Demographic Information Form was completed, and pain was assessed using the Visual Analogue Scale (VAS), while stress was evaluated using a Visual Analogue Scale (VAS). Routine monitoring and standard care were provided. The participant received routine care throughout the active phase. At the end of the phase, pain was assessed using the Visual Analogue Scale (VAS), and stress was evaluated using a Visual Analogue Scale (VAS). Routine care was continued. At the second hour postpartum, the Maternal Satisfaction in Childbirth Scale was completed.

Interventions

Participants received white noise intervention during the active phase of labor. At 4 cm cervical dilation, informed consent was obtained and baseline assessments including Demographic Information Form, Visual Analogue Scale (VAS) for pain, and Visual Analogue Scale for stress were completed. Routine care was provided. At 6 cm and 8 cm cervical dilation, participants were exposed to white noise (50-65 dB) via Bluetooth headphones for 15 minutes each session. Routine monitoring and standard obstetric care were continued. After interventions, pain and stress were reassessed using VAS. At the second postpartum hour, maternal satisfaction was assessed using the Maternal Satisfaction in Childbirth Scale.

White Noise Group

Participants received quiet time intervention during the active phase of labor. At 4 cm cervical dilation, informed consent was obtained and baseline assessments including Demographic Information Form, Visual Analogue Scale (VAS) for pain, and Visual Analogue Scale for stress were completed. Routine care was provided. At 6 cm and 8 cm cervical dilation, a quiet environment was maintained using Polter headphones for 15 minutes per session. Routine monitoring and standard obstetric care were continued. After interventions, pain and stress were reassessed using VAS. At the second postpartum hour, maternal satisfaction was assessed using the Maternal Satisfaction in Childbirth Scale.

Quiet Time Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Hospital

You may qualify if:

  • Pregnant women aged 18-35 years Pregnant women without a diagnosis of high-risk pregnancy Pregnant women with a gestational age between 37-42 weeks Pregnant women who will have a vaginal delivery Pregnant women in the active phase of labor Pregnant women who can speak or understand Turkish Pregnant women carrying a singleton fetus Primiparous women

You may not qualify if:

  • Pregnant women in the latent phase of labor Pregnant women with hearing impairment Pregnant women who are illiterate Pregnant women with an indication for cesarean section Multiparous women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esenler Women's and Children's Diseases Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master's Student

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

November 10, 2025

Primary Completion

April 11, 2026

Study Completion

April 15, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No, individual participant data will not be shared due to privacy and ethical considerations.

Locations