Clinical trial NCT06387680: The Peanut Ball Use on Labor
Official title: The Effect of Peanut Ball Use on Labor Memory, Labor Satisfaction, Delivery Length, and Neonatal APGAR Score: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Outcome, Adverse
Birth, First
Labor Long
Apgar; 4-7 at 1 Minute
Keywords: Birth memory and recall
Birth satisfaction
Labor length
APGAR score
Peanut ball
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Comparison of sociodemographic of pregnant women.
timeFrame: 6 months
measure: Comparison of obstetric characteristics of pregnant women
timeFrame: 6 months
measure: Comparison of postpartum characteristics of pregnant women
timeFrame: 6 months
measure: Comparison of duration of 1st and 2nd stage of labor by group
timeFrame: 6 months
measure: Comparison of 1st and 5th minute APGAR scores of newborns by group
timeFrame: 6 months
measure: Comparison of the mean scores of the Pregnant Women's Birth Memory and Recall Questionnaire (BirthMARQ) and its subscales by groups
timeFrame: 6 months
measure: Comparison of pregnant women's Birth Satisfaction Scale (BSS) mean scores by groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References: