NCT07316348

Brief Summary

The second stage of labor, defined as the period from full cervical dilatation to fetal birth, is a critical phase in which maternal pushing techniques may significantly affect maternal and neonatal outcomes (1-5). Evidence indicates that directed Valsalva pushing may be associated with maternal apnea, increased fatigue, pelvic floor injury, and adverse fetal effects, whereas spontaneous pushing with an open glottis supports physiological birth processes (2,5-11). The World Health Organization recommends encouraging women to follow their natural pushing urges and supports the use of open-glottis pushing techniques to promote a positive childbirth experience (12). Vocalization pushing is an open-glottis maneuver involving intentional low-tone sound production during exhalation, which may facilitate pelvic floor relaxation, improve pain management, and enhance the birth experience (9-11). However, evidence regarding the effectiveness of vocalization pushing is limited, and data from Türkiye are lacking. This randomized controlled clinical trial aims to evaluate the effects of vocalization and spontaneous pushing techniques during the second stage of labor on labor duration, pain intensity, perineal trauma, maternal fatigue, and childbirth experience.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
112

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2025

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

January 5, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

February 24, 2026

Status Verified

December 1, 2025

Enrollment Period

5 days

First QC Date

December 19, 2025

Last Update Submit

February 20, 2026

Conditions

Keywords

LaborPainSatisfactionPerineal TraumaPushing

Outcome Measures

Primary Outcomes (3)

  • Visuel Analog Scale -Pain

    Min: 0- Max:10

    When cervical dilation is 8-9 cm and within the first 30 minutes after delivery

  • Birth Experience Scale

    Min: 42- Max:150

    When cervical dilation is 8-9 cm and within the first 30 minutes after delivery

  • Visual Analogue Scale for Fatigue

    Min: 0- Max:10

    When cervical dilation is 8-9 cm and within the first 30 minutes after delivery

Study Arms (2)

ARM 2

NO INTERVENTION

No specific instructions will be given regarding how the mother should push during the second stage of labor.

ARM 1

EXPERIMENTAL

During the second stage of labor, vocalization pushing techniques (using the vowels A, O, and U to exhale in deep tones) will be encouraged, and the mother's pushing will be observed.

Procedure: The vocalization straining technique will be used.

Interventions

During the second stage of labor, vocalization pushing techniques (using the vowels A, O, and U to exhale in deep tones) will be encouraged, and the mother's pushing will be observed.

ARM 1

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being 18 years of age or older
  • Being nulliparous
  • Being at term (between 38 and 42 weeks of gestation)
  • Expecting a vaginal delivery
  • Having a singleton pregnancy
  • Presenting in vertex position
  • Estimated fetal weight between 2500-4000 g
  • Having had a complication-free pregnancy in terms of both mother and fetus
  • Not having any perinatal risks
  • Not having received any analgesia or anesthesia to relieve pain and fatigue during labor
  • Being able to read, understand, and write Turkish
  • Voluntarily agreeing to participate in the study

You may not qualify if:

  • Being multiparous
  • Having a multiple pregnancy
  • Having dysphonia and hearing loss
  • Being a high-risk pregnant woman
  • Having any systemic, chronic, or neurological disease
  • Pregnant women with fetal risk (presentation anomaly, cephalopelvic disproportion, macrosomia, SGA, fetal death, fetus without gross pathology according to ultrasound)
  • Endpoints for Cases Included in the Study:
  • Loss of the baby during labor or delivery
  • Delivery by cesarean section
  • Pharmacological intervention to relieve pain and fatigue during labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University Cerrahpaşa

Istanbul, Ataşehir, 34758, Turkey (Türkiye)

Location

Related Publications (4)

  • Sen E, Gunaydin S, Yilmaz T, Dinc Kaya H. The Effect of Music on Labor Pain and Duration: A Systematic Review and Meta-Analysis. Adv Mind Body Med. 2023 Fall;37(4):4-11.

  • Yilmaz T, Tas O, Gunaydin S, Kaya HD. The effect of Pilates on pain during pregnancy and labor: a systematic review and meta-analysis. Rev Assoc Med Bras (1992). 2023 Sep 18;69(10):e20230441. doi: 10.1590/1806-9282.20230441. eCollection 2023.

  • Dunmez F, Yilmaz T. The effect of using birth ball and squatting position during labor on pain, duration, and satisfaction: A randomized controlled trial. Jpn J Nurs Sci. 2024 Apr;21(2):e12580. doi: 10.1111/jjns.12580. Epub 2023 Dec 10.

  • Gunaydin S, Sen E, Yilmaz T, Kaya HD. Use of Transcutaneous Electrical Nerve Stimulation (TENS) in Labor Pain: An Integrative Review. Pain Manag Nurs. 2025 Feb;26(1):85-92. doi: 10.1016/j.pmn.2024.10.004. Epub 2024 Nov 12.

MeSH Terms

Conditions

PainPersonal Satisfaction

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Yasemin Dinçel

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher Assistant

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 5, 2026

Study Start

March 15, 2025

Primary Completion

March 20, 2025

Study Completion

March 15, 2026

Last Updated

February 24, 2026

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations