Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and

NCT06804577 | Active Not Recruiting

• 1 other identifier: KahramanSIU
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 2

Brief Summary

Aim: The subject of this study is to examine the effects of using a peanut ball, one of the birthing ball types, on labor pain, delivery time, anxiety and maternal satisfaction in primiparous pregnant women who are planned to have a vaginal birth Material method:In the appointment, it was planned that there would be 54 people in each group. Pregnant women who meet the research criteria and agree to participate will be distributed to the groups by simple randomization method. The research sample is in the maternity unit at Gaziantep City Hospital (between August 2024 and December 2024) and all primiparous women who meet the inclusion criteria for the study will be included.

Conditions

First Birth; Labor Pain; Anxiety; Birth Satisfaction

Keywords

peanut ball; labor pain; birth time; birth satisfaction

Outcome Measures

Primary Outcomes (2)

• Visual analog scale (VAS)

  A 10 cm ruler with no pain at one end and the most severe pain at the other end, the patient's own pain signs, the use of VAS should be explained very well. This is natural; patients are said to have two extreme points and to be free to remember between these points. The validity and reliability of the scale were made by Aslan (1998).

  1 hour

• State Anxiety Scale (VAS)

  Spielberger's State Anxiety Inventory: The scale was adapted to Turkish by Öner and Le Compte (1983) in 1964 by Spielberg and his friends in order to classify the degree of normal and abnormal situations. It is a self-assessment type scale consisting of short statements. The state anxiety inventory is available in a way that the person can use their anxiety at a certain moment, the state anxiety inventory consisting of 20 items is a scale that molds how the individual wants himself at a certain moment and under certain conditions. The emotions or behaviors expressed in the state record inventory classes are answered by marking one of the options (1) none, (2) a little, (3) a lot, (4) completely according to the degree of distribution. There are 10 reversed statements in the inventory. These statements are items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20. The state anxiety score is calculated by adding the total weighted scores of direct and reverse statements to 50 points. The scores obtai

  1 month

Secondary Outcomes (1)

• State Anxiety Scale (VAS)

  1 hour

Other Outcomes (1)

• Maternal Satisfaction Assessment Scale for Normal Birth (NDAMDÖ)

  1 hour

Study Arms (2)

Behavioral: Educational with milnacipran

EXPERIMENTAL

IStage 1: When the cervical dilatation of the pregnant woman was 4-5 cm, DCO was applied after VAS 1 application. VAS 2 was applied 15 minutes after DKÖ 1 was applied. Stage 2: When the pregnant woman's cervical dilatation was 6-7 cm, VAS 3 was applied by the researcher. VAS 4 was applied 15 minutes after VAS 3 was applied. Stage 3: DKÖ 2 was applied when the pregnant woman's cervical dilatation was 7-8 cm. Stage 4: VAS 5 was applied when the pregnant woman's cervical dilatation was 8 cm and above. VAS 6 was applied 15 minutes after VAS 5 was applied. Stage 5: When the cervical effacement and dilation of the pregnant woman is completed and the fetal head rests on the perineum, the pregnant woman is taken to the delivery table. Stage 6: In the fourth stage of labor, between the second and third hours, the researcher will apply DCO and NDAMDS.

Other: peanut ball

control group

NO INTERVENTION

standard care group

Interventions

peanut ball OTHER

The experimental group will use peanut balls;

Behavioral: Educational with milnacipran

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

Sponsors & Collaborators

• Ayşe FİLİZ: lead
• Kahramanmaras Sutcu Imam University: collaborator

Study Sites (2)

Kahramanmaraş Sütçü İmam Universty

Çağlayanceri̇t, Kahramanmaraş, 0046, Turkey (Türkiye)

Location

Kahramanmaraş Sütçü İmam Universty

Kahramanmaraş, 46, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Anxiety Disorders

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel asigment

Study Record Dates

• First Submitted: October 27, 2024
• First Posted: February 3, 2025
• Study Start: January 1, 2025
• Primary Completion: May 30, 2025
• Study Completion: November 30, 2025
• Last Updated: February 3, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (2)