The Peanut Ball Use on Labor

Labor Long Clinical Trial

Official title:

The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06387680
• Other study ID #: 2022/187
• Status: Completed
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 1, 2024

Study information

• Verified date: April 2024
• Source: Selcuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores.

Description:

The purpose of this study was to evaluate the effect of using peanut balls during labor on labor memory, labor satisfaction, labor length, and neonatal APGAR scores. This randomized, controlled, single-blind trial was conducted in 156 primiparous pregnant women (peanut ball group n=78, control group n=78) who delivered between March 2024 and October 2024. Pregnant women in the peanut ball group were instructed to perform movements with the peanut ball after cervical dilation reached 4 cm. The control group received only standard intrapartum midwifery care. Data were collected by personal information form, labor and postpartum follow-up form (APGAR score, etc.), Birth Memory and Recall Scale 4 hours after delivery, and Birth Satisfaction Scales.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 1, 2024
• Est. primary completion date: March 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

Pregnant women were included if they had indications for vaginal delivery,

• Were primiparous,
• Had cervical dilation of 3 cm or more,
• Had term pregnancy (38 to 42 weeks of gestation),
• Had a single,
• Healthy,
• Vertex-positioned fetus,
• Had no complications that could cause dystocia during labor (contraction anomalies, birth object, dystocia related to the birth canal, dystocia related to the mother's psyche, dystocia related to the mother's psychology),
• Did not use analgesia and anesthesia during the first stage of labor,
• I did not have any physical disability to take the positions to be used in the study,
• Did not have any communication problems,
• Had language skills sufficient to speak and understand Turkish.

Exclusion Criteria:

• Pregnant women were excluded if they had abnormal changes in fetal heart rate during labor (fetal distress, etc.),
• Had an unexpected pregnancy or fetal complication,
• Had a high-risk pregnancy,
• Were taking magnesium sulfate,
• Had symptoms of intrauterine infection,
• Had previously attended antenatal classes,
• Or reported having been educated about birthing balls.

Related Conditions & MeSH terms

• Apgar; 4-7 at 1 Minute
• Birth, First
• Labor Long
• Pregnancy Complications

Intervention

Other:
• The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial

Locations

Country	Name	City	State
Turkey	Selcuk University	Konya

Sponsors (1)

Lead Sponsor	Collaborator
Selcuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of sociodemographic of pregnant women.	Sociodemographic of pregnant women will be collected through surveys and compared and reported.	6 months
Primary	Comparison of obstetric characteristics of pregnant women	Obstetric of pregnant women will be collected through surveys and compared and reported.	6 months
Primary	Comparison of postpartum characteristics of pregnant women	Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.	6 months
Primary	Comparison of duration of 1st and 2nd stage of labor by group	The 1st and 2nd stages of the birth of pregnant women will be followed by the midwife and notes will be taken in the survey.	6 months
Primary	Comparison of 1st and 5th minute APGAR scores of newborns by group	The 1st and 5th minute APGAR scores of newborns will be noted in the survey.	6 months
Primary	Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups	BirthMARQ scale will be applied to pregnant women. BirthMARQ ranges from 1 to 147 points (min-max), with higher scores indicating poor mood and more frequent involuntary recall.	6 months
Primary	Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups	BSS scale will be applied to pregnant women.BSS is 0-40 points (min-max), and as the score increases, the level of birth satisfaction increases.	6 months