The Effect of Peanut Ball Application on Delivery Process

NCT06200688 | Completed DMC

• 1 other identifier: 745044
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

This study was carried out to evaluate the effect of peanut ball application on labor process, birth pain, and birth comfort. The data of the study were collected between July 2021 and July 2022 in a Training and Research Hospital in Istanbul. 115 pregnant women who met the inclusion criteria of the study were included in the sampling, and the study was completed with 102 (experimental n: 51; control n: 51) pregnant women. Data were collected with an introductory information form, visual and verbal pain scales, Birth Comfort Scale, and birth follow-up form.

Conditions

Birth, First

Outcome Measures

Primary Outcomes (3)

• Birth duration

  Birth duration was assessed using a partograph.

  1 day

• Birth pain

  Labor pains in the dilatation phase: dilation 6 cm, 9 cm and 10 cm with VAS It was evaluated 3 times in total during the time it was cm. During this period, pregnant women were asked to VAS They were asked to score the pain they felt between 1 and 10, and the expressed values were recorded by the researcher.

  8 hours

• Birth comfort

  The birth comfort scale was administered to pregnant women by the researcher within the first 4 hours after birth.

  15 minutes

Secondary Outcomes (2)

• Pregnancy introductory information

  15 minutes

• Birth Follow-up

  1 day

Study Arms (2)

Peanut Ball Group

EXPERIMENTAL

In this group, pregnant women changed positions with a peanut ball during labor.

Other: PEANUT BALL

Control Group

NO INTERVENTION

No intervention was applied in this group.

Interventions

PEANUT BALL OTHER

Experimental Group: Pregnant women who were applied with a peanut ball were informed about the necessary information related to the ball by the midwife with a visual representation of the positions. A total of 5 positions were shown to the pregnant women. Peanut ball was started to be used when the cervical dilation reached 6 cm. Pregnant women in the active phase, the transition phase, and the second stage of labor where the peanut ball was applied were directed to change positions every 30-45 minutes. Importance was given to selecting positions where the pregnant woman felt comfortable. Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was generally observed that pregnant women spent the time until delivery lying down and connected to electronic fetal monitoring.

Peanut Ball Group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Gender Eligibility Details: Pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primiparous pregnant women
• w-40w gestational week (term)
• Pregnant women over the age of 18 years

You may not qualify if:

• Pregnant women who gave birth by cesarean section
• who had received epidural anesthesia/analgesia

Sponsors & Collaborators

• Istanbul Medipol University Hospital: lead

Study Sites (1)

Istanbul Medipol University

Istanbul, Beykoz, 34430, Turkey (Türkiye)

Location

Study Officials

• YELİZ YILDIRIM VARIŞOĞLU

  Medipol University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Asist.

Model Details: Experimental Group: Pregnant women who received the peanut ball application were provided with necessary information about the ball and how to use it through visual aids showing the positions provided by the midwife. A total of 5 positions were shown to the pregnant women. The peanut ball was used when the cervical dilation reached 6 cm. Pregnant women in active labor, the transition phase, and the second stage with the peanut ball were directed to change positions every 30-45 minutes. Emphasis was placed on selecting positions in which the pregnant women felt comfortable. Control Group: No intervention was made other than routine practices within the clinic for pregnant women. It was observed that pregnant women generally spent the time before delivery lying down and connected to electronic fetal monitoring.

Study Record Dates

• First Submitted: December 16, 2023
• First Posted: January 11, 2024
• Study Start: July 1, 2021
• Primary Completion: April 1, 2023
• Study Completion: May 28, 2023
• Last Updated: January 11, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)