CClinicalTrials.gg
CompletedNCT05360823Updated Jul 28, 2022

The Effect of Using a Birth Ball and Squatting Position During Labor

An interventional study of Birth ball and Squatting in Labor Pain, Labor Fast and Satisfaction, Patient, sponsored by Fatma Dünmez. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-28.

Sponsored by Fatma Dünmez · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jul 2021, registered Apr 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
159
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
Female
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Study 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.

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Conditions studied

  • Labor Pain
  • Labor Fast
  • Satisfaction, Patient

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Keywords

  • Labor Pain
  • Birth ball
  • Squatting
  • Duration of labor
  • Satisfaction
03

In context

Labor Pain

396 studies on the registry are indexed under Labor Pain; 66 are open to participants now.

This study's enrollment of 159 is above the median of 100 across 326 interventional studies indexed under Labor Pain.

Browse Labor Pain studies →

Lead sponsor

This is the only study on the registry with Fatma Dünmez as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Any complication development
  • Cesarean section status
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
159 participants (actual)

Study arms

  • Experimental
    Birth Ball Group

    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

  • Experimental
    Squatting Group

    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

  • No intervention
    Control Group

    Usual routine care of the service.

Interventions

  • OtherBirth ball

    Exercises for childbirth

  • OtherSquatting

    Exercises for childbirth

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: pre-intervention

  2. 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.

    Time frame: latent, active and transition phase of labor

  3. Partogram

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

    Time frame: active phase of labor

  4. 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.

    Time frame: Postpartum at the 4th hour

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Study locations

1 site
  • Istanbul University-Cerrahpasa
    Istanbul, Turkey
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References and documents

Publications

  • 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. PubMed 31060522 ↗
  • 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. PubMed 30080256 ↗
  • 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. PubMed 21546142 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05360823
Lead sponsor
Fatma Dünmez
Responsible party
Fatma Dünmez (Midwifery-Master Student, Istanbul University - Cerrahpasa) — Sponsor-investigator
First posted
May 4, 2022
Start date
Jul 3, 2021
Primary completion
Jan 20, 2022
Completion
Jun 24, 2022
Last update
Jul 28, 2022

Study contacts

Fatma Dünmez, Midwife
principal investigator · Istanbul University - Cerrahpasa

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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