Clinical trial NCT06200688: The Effect of Peanut Ball Application on Delivery Process
Official title: The Effect of Peanut Ball Application on the Delivery Process, Birth Pain, and Birth Process: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth, First
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-01-11
Enrollment: 102
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Birth duration
timeFrame: 1 day
measure: Birth pain
timeFrame: 8 hours
measure: Birth comfort
timeFrame: 15 minutes
Secondary outcomes:
measure: Pregnancy introductory information
timeFrame: 15 minutes
measure: Birth Follow-up
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
state: Beykoz
Study officials:
affiliation: Medipol University
name: YELİZ YILDIRIM VARIŞOĞLU
role: PRINCIPAL_INVESTIGATOR
References: