Clinical trial NCT06804577: Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and
Official title: Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and Maternal Satısfactıon
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: First Birth
Labor Pain
Anxiety
Birth Satisfaction
Keywords: peanut ball
labor pain
birth time
birth satisfaction
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
Collaborators: name: Kahramanmaras Sutcu Imam University
First posted: 2025-02-03
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Parallel asigment
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Type of Study This study is a pretest-posttest randomized controlled, intervention and control two parallel group experimental study Place of Study It will be conducted in the delivery room of Gaziantep City Hospital. Research Universe: The research universe consists of primiparous pregnant women who are planned to have vaginal birth in the delivery room unit of Gaziantep City Hospital.

Research Sample Since the effect size regarding the labor comfort and labor satisfaction scales could not be obtained from the studies conducted, sample calculations could not be made for these scales in our study (Ersoy 2011, Gau et al 2011, Akın 2016, Akın and Saydam 2020). Therefore, it was determined that 60 pregnant women should be included in each group, assuming that the effect size would be 0.6 (medium), at a 5% Type I error level, and the study power was 90%. It was determined that a total of 120 primiparous pregnant women should be included in the study sample. During the study, there were no pregnant women in either group who had an emergency cesarean section or converted from normal birth to cesarean section.

Data Collection Tools The research data were collected using the Personal Information Form to determine the sociodemographic characteristics, obstetric characteristics and preparation characteristics for birth of the pregnant women, the Visual Analog Scale (VAS) to determine the labor pains perceived by the pregnant women, the State Anxiety Scale to measure the anxiety level of the pregnant women at the time of birth and the Maternal Satisfaction Evaluation Scale for Normal Birth for birth satisfaction.

Personal Information Form The form prepared by the researcher based on the literature included 11 questions regarding the sociodemographic characteristics of the women (age, height, weight, education level, marital status, employment status, income level perception, income level, place of residence, family structure, smoking); There are 5 questions about obstetric characteristics (gestational week, abortion-curettage history, pregnancy desire, regular prenatal care, where care is received) and 6 questions about preparation for birth (receiving childbirth preparation education, where education is received, preparation for motherhood, spousal support during pregnancy, family and friend support during pregnancy, satisfaction with pregnancy) for a total of 22 questions (Ersoy 2011, Chu et al 2017, Shirazi et al 2019, Kanedi et al 2019, Hildingsson and Rubertsson 2020, Akın and Saydam 2020).

VAS (Visual Analog Scale) The scale developed by Price et al. (1983) is used to determine the severity and level of pain in the patient. The scale defines pain as "0" no pain, "10" very severe on a 10 cm straight line. The patient is asked to mark a point on this line that corresponds to the level of pain he/she will feel. Accordingly, the marked point in centimeters is evaluated as the level of pain. On the scale, "0" indicates no pain, "2" indicates mild pain, "4" moderate pain, "6" severe pain, "8" very severe pain, and "10" unbearable pain. This scoring also shows the increase in the level of pain as the numerical value increases (Price 1983). State Anxiety Inventory (SAI) Spielberger's State Anxiety Inventory: The scale, developed by Spielberg and his colleagues in 1964 to measure the level of state anxiety of normal and abnormal individuals, was adapted to Turkish by Öner and Le Compte (1983). It is a self-assessment type scale consisting of short statements. The state anxiety inventory was developed to measure a person's anxiety at a certain moment. The state anxiety inventory, consisting of 20 items, is a scale that determines how an individual feels at a certain moment and under a certain condition. The feelings or behaviors expressed in the state anxiety inventory items are answered by marking one of the following options according to their intensity: (1) not at all, (2) a little, (3) a lot, (4) completely. 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 50 points to the difference between the total weighted scores of direct statements and reverse statements. The scores obtained in the state anxiety scale theoretically vary between 20 and 80 points. In the evaluation of the scale, it is accepted that those who score below 36 have no anxiety, those who score between 37-42 have mild anxiety, and those who score 42 and above have high anxiety (14) Normal Birth Maternal Satisfaction Assessment Scale (NDAMDS) NDAMDS was developed by Güngör and Beji (190). The relevant scale consists of a total of 43 items and 10 sub-dimensions. The sub-dimensions of the scale and item numbers are; perception of the health team (items 1, 2, 3, 4), care during labor (items 5, 6), comfort (items 7, 8, 9, 10), participation in decision-making and information (items 8, 11, 12, 13, 14, 15, 16, 17-32), meeting the baby (items 19, 20, 21), postpartum care (22, 23, 24,25, 26, 27), hospital room (28, 29, 30, 31), hospital facilities (items 32, 33, 34), privacy

Eligibility criteria: Inclusion Criteria Pregnant women with a singleton pregnancy, Term, primiparous, No condition preventing vaginal delivery, No extremity problems related to using a birth ball, Can speak and understand Turkish.

Exclusion Criteria Pregnant women with maternal and fetal complications (oligohydramnios and polyhydramnios, placenta previa, preeclampsia, premature membrane rupture, presentation anomalies, IUGR, fetal anomalies, intrauterine death, macrosomic baby, fetal distress, etc.) Elective cesarean section

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: 1 hour
measure: State Anxiety Scale (VAS)
timeFrame: 1 month
Secondary outcomes:
measure: State Anxiety Scale (VAS)
timeFrame: 1 hour
Other outcomes:
measure: Maternal Satisfaction Assessment Scale for Normal Birth (NDAMDÖ)
timeFrame: 1 hour
Locations:
city: Çağlayanceri̇t
country: Turkey
facility: Kahramanmaraş Sütçü İmam Universty
state: Kahramanmaraş
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaraş Sütçü İmam Universty
Study officials:
References: