The Effect of Using Peanuts Balls at Birth

NCT06808620 | Enrolling By Invitation DMC

• 1 other identifier: B.30.2.ATA.0.01.00/295
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

Brief Summary

The necessity of applying the research on humans, whether the application has been done in our country or in other countries before, if it has been done, additional data expected from this study or differences from this study from others, and the expected benefits, please explain within the framework of scientific data. With this planned study, it is aimed to increase the activities of pregnant women during birth by using peanut balls during the birth process, to support the pregnant women psychologically, to reduce labor pains, to shorten the duration of normal birth, to increase self-efficacy for normal birth, to reduce cesarean section rates, to increase labor satisfaction, to reduce fear of birth, to expand the pelvic diameter, to stretch the pelvic muscles and to provide positive gains on connective tissues. With this planned study, it is aimed to reduce labor pain, to shorten the duration of labor and to increase the self-efficacy of the pregnant women for vaginal birth by using peanut balls during the birth process and benefiting from the stated benefits. When the literature review was done, it was determined that partial studies were conducted on the effect of peanut balls on birth in Turkey and in the world, and it was determined that peanut balls are not used in delivery rooms in Turkey despite having many benefits on birth. This study aims to pioneer the widespread use of peanut balls in Turkey. This study was planned to determine the effect of using peanut balls on labor duration, perceived labor pain and self-efficacy in primiparous pregnant women with a cervical dilation of 4 cm and above, in line with the vaginal birth plan. The aim of the planned study is to evaluate the effect of changing position with peanut balls during labor on perceived labor pain, labor duration and self-efficacy levels for normal birth. The hypotheses of the study proposed for this purpose are; H1: Labor pain, duration and self-efficacy of pregnant women who use peanut balls during labor are different from the control group. H2: Perceived labor pain decreases in pregnant women who use peanut balls during labor compared to the control group. H3: The duration of labor (the time period from the active phase to the completion of the transition phase) is shortened in pregnant women who use peanut balls during labor compared to the control group. H4: The duration of labor (the second stage of labor) is shortened in pregnant women who use peanut balls during labor compared to the control group. H5: Using peanut balls during birth increases the self-efficacy level in pregnant women compared to the control group. The peanut ball will be applied in 6 different positions. These positions will consist of side-lying positions, half-sitting pose, forward bending pose and squatting positions. The positions to be applied are planned as in-bed. Pregnant women will be informed about the positions to be applied. The peanut ball will be applied for 20-25 minutes and a 5-10 minute break will be given. The introductory and obstetric information form will be filled out once for each patient. The partograph will be started with the start of the peanut ball use and will end with the end of labor. The visual comparison scale (VAS) and the self-efficacy scale for normal labor will be used 3 times in this study. It will be applied when the dilation is 4 cm and below before the application, immediately after the peanut ball application and half an hour after the peanut ball application.

Conditions

Exercise; Labor; Birth

Keywords

Labor Pain; Labor Duration; Self-Sufficiency; Peanut Ball; Vaginal Birth

Outcome Measures

Primary Outcomes (3)

• Perceived labor pain (Visual Analog Scale)

  The visual analog scale (VAS) was developed by Price et al. (1983) to determine the level of perceived pain during labor. VAS is used easily and conveniently by converting some situations that are difficult to measure quantitatively into numerical values (Yeşilyurt and Faydalı, 2020). The visual comparison scale is in the form of a 10 cm vertical and horizontal ruler. In order to determine the intensity of pain, one end indicates the lowest level of perceived pain and the other end indicates that the intensity of pain increases. If there is no perceived pain, "0" is shown, and the number "10" indicates the highest level of pain. The pregnant woman in pain evaluates her own pain out of 10 and indicates the appropriate number for herself. A score of 1-4 on this scale indicates mild pain, 5-6 indicates moderate pain, and a score above 7 indicates severe pain (Ayan et al., 2013). No cut-off point is specified in the visual comparison scale. Its use is recommended in comparative studies

  During labor

• Labor duration

  Effect of using peanut ball on labor duration

  Labor

• Perception of Self-Efficacy for Normal Birth

  Effect of using peanut ball on self-efficacy perception for normal birth

  During labor

Study Arms (2)

No Intervention: Control

NO INTERVENTION

The group which has no implementation

Use of peanut ball

EXPERIMENTAL

The group which peanut ball are implemented

Other: The group where the peanut ball is used

Interventions

The group where the peanut ball is used OTHER

Before the application, the appropriate ball size for the physical characteristics and comfort of the pregnant women will be determined. Pregnant women will be given 4 different sizes of peanut balls with a diameter of 40, 55, 65 and 75 cm. In order for the pregnant woman to continue her in-bed balance exercises and position changes, she will be allowed to sit on the peanut ball with her knees and hips at an angle of approximately 90° and her spine upright. A 40-55 cm birthing ball will be used for women between 150-160 cm tall, a 65 cm birthing ball for women between 160-170 cm tall, and a 75 cm birthing ball for women between 170-185 cm tall. Position changes with the peanut ball will be carried out in accordance with a position/exercise guide prepared by researchers in line with literature information. The peanut ball will be applied in 6 different positions. These positions to be applied will consist of side-lying positions, semi-sitting pose, forward bending pose and squatting pos

Also known as: The group which has no implementation

Use of peanut ball

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Pregnant women should be in their 38-42nd weeks of pregnancy
• Cervical dilation should be 3 cm or more
• Single live baby
• Vertex position should be
• No health problems
• No communication problems
• No risky pregnancies
• Those who can have vaginal birth
• Primiparous pregnancy
• Active phase

You may not qualify if:

• Indication for Caesarean section
• Complications during delivery
• Unwilling to continue working
• Risky pregnancies

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Atatürk Universty

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity; Labor Pain

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Association Professor

Model Details: Randomized Controlled Study

Study Record Dates

• First Submitted: October 11, 2024
• First Posted: February 5, 2025
• Study Start: October 30, 2024
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 5, 2025

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)