Labor Pain Clinical Trial
Official title:
The Effect of Using a Birth Ball and Squatting Position During Labor on Labor Pain, Duration of Labor and Satisfaction
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 |
Verified date | July 2022 |
Source | Istanbul University-Cerrahpasa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul University-Cerrahpasa | Istanbul |
Lead Sponsor | Collaborator |
---|---|
Fatma Dünmez |
Turkey,
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
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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