The Effect of Peanut Ball Application on Delivery Process

NCT ID: NCT06200688

Last Updated: 2024-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-01
• Study Completion Date: 2023-05-28

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.

Detailed 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

Conditions

Birth, First

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Peanut Ball Group

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

Group Type: EXPERIMENTAL

PEANUT BALL

Intervention Type: 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.

Control Group

No intervention was applied in this group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Istanbul Medipol University Hospital

OTHER

Sponsor Role: lead

Responsible Party

YELİZ YILDIRIM VARIŞOĞLU

Prof. Asist.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

YELİZ YILDIRIM VARIŞOĞLU

Role: PRINCIPAL_INVESTIGATOR

Medipol University

Locations

Istanbul Medipol University

Istanbul, Beykoz, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

745044

Identifier Type: -

Identifier Source: org_study_id