AzTrials
AzTrials

First BirthNCT06804577

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

A study testing peanut ball in people with First Birth and Labor Pain, run by Ayşe FİLİZ at 2 sites in Turkey (Türkiye).

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 years, women onlyHealthy volunteers can take part
Conditions the study is for
First Birth, Labor Pain, Anxiety
What is being tested?
peanut ball
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
2 sitesTurkey (Türkiye)
Study dates
1 Jan 2025to 30 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • Women only
  • Healthy volunteers accepted
  • Adult

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

Trial locations and contacts

2 sites in 1 country.

Turkey (Türkiye)2 sites
  • Kahramanmaraş Sütçü İmam Universty

    Çağlayanceri̇t, Kahramanmaraş, 0046

  • Kahramanmaraş Sütçü İmam Universty

    Kahramanmaraş, 46

Other trials in Turkey (Türkiye)

About this study

Official title: Effect of Peanut Ball Use ın Prımarıes on Labor Paın, Duratıon of Labor Anxıety and Maternal Satısfactıon

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.

Read the 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

Being tested
peanut ball
Keywords
peanut ball, labor pain, birth time, birth satisfaction
Medical subject headings
Labor Pain, Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • peanut ballOther

    The experimental group will use peanut balls;

Study groups in NCT06804577
Study groupRoleWhat they receive
Behavioral: Educational with milnacipranExperimentalIStage 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.
Receives: Other: peanut ball
control groupNo interventionstandard care group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 1 hour

  2. 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

    Measured: 1 month

Secondary outcomes (1)
  1. 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

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Feb 2025
  2. Study start1 Jan 2025
  3. Primary completion30 May 2025 (estimated)
  4. Study completion30 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Single group
Model description
Parallel asigment
Masking
Single blind
Who is masked
Care provider
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06804577
Sponsor's protocol ID
KahramanSIU
Status last verified
Jan 2025
First submitted
27 Oct 2024
Last updated
3 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing peanut ball in people with First Birth and Labor Pain, run by Ayşe FİLİZ at 2 sites in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual analog scale (VAS) (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in