NCT06387680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
Last Updated

April 15, 2025

Status Verified

April 1, 2025

Enrollment Period

1.2 years

First QC Date

April 16, 2024

Last Update Submit

April 13, 2025

Conditions

Keywords

Birth memory and recallBirth satisfactionLabor lengthAPGAR scorePeanut ball

Outcome Measures

Primary Outcomes (7)

  • Comparison of sociodemographic of pregnant women.

    Sociodemographic of pregnant women will be collected through surveys and compared and reported.

    6 months

  • Comparison of obstetric characteristics of pregnant women

    Obstetric of pregnant women will be collected through surveys and compared and reported.

    6 months

  • Comparison of postpartum characteristics of pregnant women

    Postpartum characteristics of pregnant women will be collected through surveys and compared and reported.

    6 months

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Peanut Ball Group

EXPERIMENTAL

When the cervical dilation reached 4 cm, the peanut ball was first applied to the pregnant women in the side-lying position (right side/left side) for 20 minutes, and then the pregnant women were allowed to rest for 10 minutes. Second, the semi-seated position was applied for 20 minutes and the pregnant women were allowed to rest for 10 minutes. Third, the supine position was applied for 20 minutes followed by 10 minutes of rest. Fourth, the hand-knee position was applied for 20 minutes and rested for 10 minutes. Finally, the squatting position was practiced for 20 minutes and then the pregnant women rested for 10 minutes. Each position was practiced with the peanut ball for 20 minutes and rested for 10 minutes. Each position was performed once during the procedure. A pregnant woman who wished to remain in a position longer was allowed an additional 10 minutes without interrupting the flow of the intervention and then rested for 10 minutes.

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

Control Group

NO INTERVENTION

Control Group (CG) No intervention other than routine intrapartum midwifery care was provided to primiparous pregnant women in the control group. After admission to the hospital for delivery, the pregnant women in the control group were informed about the study, written informed consent was obtained, routine practices and care in the delivery room were performed (taking history, taking vital signs, demonstrating correct breathing techniques, ensuring freedom of movement), vaginal examination and cervical changes were recorded on the partograph, EFM (electronic fetal monitoring) was performed when the time came according to the doctor's order, fetal heart rate (FHR) was listened to every half hour and recorded on the partograph.

Interventions

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

Peanut Ball Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Selcuk University

Konya, 42250, Turkey (Türkiye)

Location

Related Publications (1)

  • Cankaya S, Alan Dikmen H, Atas A. The effect of peanut ball use on labor memory, labor satisfaction, delivery length, and neonatal APGAR score: a randomized controlled trial. Postgrad Med. 2025 Jun;137(5):368-378. doi: 10.1080/00325481.2025.2510198. Epub 2025 May 26.

MeSH Terms

Conditions

Pregnancy Complications

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Seyhan Çankaya

Study Record Dates

First Submitted

April 16, 2024

First Posted

April 29, 2024

Study Start

January 1, 2023

Primary Completion

March 1, 2024

Study Completion

March 1, 2024

Last Updated

April 15, 2025

Record last verified: 2025-04

Locations