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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05360823
Other study ID # ISBASP
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 3, 2021
Est. completion date June 24, 2022

Study information

Verified date July 2022
Source Istanbul University-Cerrahpasa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 159
Est. completion date June 24, 2022
Est. primary completion date January 20, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 35 Years
Eligibility 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: - Any complication development - Cesarean section status

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Birth ball
Exercises for childbirth
Squatting
Exercises for childbirth

Locations

Country Name City State
Turkey Istanbul University-Cerrahpasa Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Fatma Dünmez

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

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:CD005461. doi: 10.1002/14651858.CD005461.pub5. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary Partogram It is a graphical form used to evaluate the progress of birth and the health status of the baby. active phase of labor
Primary 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
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