The Effect of Peanut Ball Application on Delivery Process

Birth, First Clinical Trial

Official title:

The Effect of Peanut Ball Application on the Delivery Process, Birth Pain, and Birth Process: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06200688
• Other study ID #: 745044
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: May 28, 2023

Study information

• Verified date: December 2023
• Source: Istanbul Medipol University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A group was determined to be involved in the study after obtaining consent from the pregnant women participating in the research. The purpose of the study was explained to all pregnant women, informing them that the data would be anonymized and privacy principles would be adhered to. 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. In the Birth Monitoring Form, the gestational week found in the patient's file, interventions and medications applied in the first stage of labor, the situation of episiotomy application in the second stage, the newborn's birth time, and 1st and 5th APGAR scores, newborn's length, weight, head circumference, and gender were recorded. In both groups, labor pains during the dilation stage were evaluated three times using the Visual Anolog Scale (VAS) when the dilation was at 6 cm, 9 cm, and 10 cm. During this period, the pregnant women were asked to rate the pain they felt on the VAS scale from 1 to 10, and the values expressed were recorded by the researcher. The childbirth comfort scale and the form indicating mothers' views

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: May 28, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Primiparous pregnant women
• 37w-40w gestational week (term)
• Pregnant women over the age of 18 years

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Birth, First

Intervention

Other:
• PEANUT BALL
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.

Locations

Country	Name	City	State
Turkey	Istanbul Medipol University	Istanbul	Beykoz

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Medipol University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth duration	Birth duration was assessed using a partograph.	1 day
Primary	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
Primary	Birth comfort	The birth comfort scale was administered to pregnant women by the researcher within the first 4 hours after birth.	15 minutes
Secondary	Pregnancy introductory information	A pregnancy information form was used for all pregnant women after randomization to identify and evaluate the sociodemographic and socioeconomic information of the pregnant women.	15 minutes
Secondary	Birth Follow-up	In the Birth Follow-up Form, it is included in the hospitalization file of the pregnant woman.; gestational week, interventions and medications administered in the first stage of labor, Episiotomy application status in the second stage, newborn birth time, 1st and 5th APGAR and Newborn height, weight, head circumference and gender were evaluated and recorded.	1 day