NCT05360823

Brief Summary

The aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction. The research is a randomized controlled experimental study. The sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
159

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

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

July 3, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 4, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

7 months

First QC Date

April 26, 2022

Last Update Submit

July 26, 2022

Conditions

Keywords

Labor PainBirth ballSquattingDuration of laborSatisfaction

Outcome Measures

Primary Outcomes (4)

  • Personal and Obstetric Information Form

    This form, prepared by the researcher, consists of 45 questions including sociodemographic, obstetric and obstetric follow-up information of women.

    pre-intervention

  • Visual Analog Scale (VAS)

    It is a measuring instrument with a score between 0 (no pain) and 10 (severe pain), divided equally by marks on a horizontal or vertical 10 cm line. Horizontal form was used in the research. The scale was used to assess the severity of pain.

    latent, active and transition phase of labor

  • Partogram

    It is a graphical form used to evaluate the progress of birth and the health status of the baby.

    active phase of labor

  • Evaluation Scale for Maternal Satisfaction with Normal Delivery

    This is used to assess the mother's level of satisfaction at birth. The scale, which has a validity and reliability of 0.91 in Turkey, was developed by Güngör and Beji in 2009. It is a 5-point Likert-type scale consisting of 43 items and 10 sub-dimensions.

    Postpartum at the 4th hour

Study Arms (3)

Birth Ball Group

EXPERIMENTAL

In the active and transitional phases, during contractions, performing exercises on the birth ball (fully rotating the hip, moving to the right/left, coming back and forth, and slightly bouncing while sitting on the birth ball) (average 25 minutes). In order to monitor the condition of the fetus, exercises on the birth ball were performed by the pregnant woman during contractions while connected to NST.

Other: Birth ball

Squatting Group

EXPERIMENTAL

In the active and transitional phase, squatting position (squatting with feet shoulder-width apart by laying a clean sheet on the floor and getting support from a bed, chair or birth ball) during contractions (average 25 minutes). In order to monitor the condition of the fetus, the squatting position was used by the pregnant woman during contractions while connected to the NST.

Other: Squatting

Control Group

NO INTERVENTION

Usual routine care of the service.

Interventions

Exercises for childbirth

Birth Ball Group

Exercises for childbirth

Squatting Group

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No risky pregnancy
  • Gestational week between 37-42
  • Unopened amniotic membrane
  • Those who will give birth vaginally
  • In active phase
  • Fluent in Turkish
  • Singleton pregnancy
  • Primiparous

You may not qualify if:

  • Any complication development
  • Cesarean section status

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (4)

  • Yeung MPS, Tsang KWK, Yip BHK, Tam WH, Ip WY, Hau FWL, Wong MKW, Ng JWY, Liu SH, Chan SSW, Law CK, Wong SYS. Birth ball for pregnant women in labour research protocol: a multi-centre randomised controlled trial. BMC Pregnancy Childbirth. 2019 May 6;19(1):153. doi: 10.1186/s12884-019-2305-8.

    PMID: 31060522BACKGROUND
  • Lavender T, Cuthbert A, Smyth RM. Effect of partograph use on outcomes for women in spontaneous labour at term and their babies. Cochrane Database Syst Rev. 2018 Aug 6;8(8):CD005461. doi: 10.1002/14651858.CD005461.pub5.

    PMID: 30080256BACKGROUND
  • Gungor I, Beji NK. Development and psychometric testing of the scales for measuring maternal satisfaction in normal and caesarean birth. Midwifery. 2012 Jun;28(3):348-57. doi: 10.1016/j.midw.2011.03.009. Epub 2011 May 4.

    PMID: 21546142BACKGROUND
  • 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.

Related Links

MeSH Terms

Conditions

Labor PainPatient SatisfactionPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Fatma Dünmez, Midwife

    Istanbul University - Cerrahpasa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Midwifery-Master Student

Study Record Dates

First Submitted

April 26, 2022

First Posted

May 4, 2022

Study Start

July 3, 2021

Primary Completion

January 20, 2022

Study Completion

June 24, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations