Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06229808
Status:
COMPLETED
Last Update Posted:
2024-01-29
First Post:
2024-01-03
Brief Title:
The Effect of the Multifunctional Birthing Ball on Labor Pain
Sponsor:
Near East University Turkey
Organization:
Near East University Turkey
Study Overview
Official Title:
New Design Investigation of the Effect of Multifunctional Birthing Ball on Perineal and Sacral Pain and Duration of Labor in the First Two Stages of Labor
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Objective By using the newly designed multifunctional birthing ball it is aimed to reduce the intense perineal and sacral pain in the first and second stages of labor to prevent perineal tears pain and episiotomy opening with perineal heating to take advantage of the positive effects of the birthing ball on the pelvis to support active labor and shorten the duration of labor and to increase the satisfaction of mothers with labor by reducing anxiety and pain
Materials and Methods The multifunctional birthing ball will support the active movements of the pregnant woman as well as warming the perineum while providing lumbar and back massage The multifunctional birthing ball was developed by researchers and manufactured by the Near East University 3D Lab The bottom of the ball is made of flexible and explosion-proof material filled with air The purpose of the ball is to enable the pregnant woman to make swinging and bouncing movements during active labor The massager and heating pad will be controlled by a single electronic circuit Three different massage modes can be selected continuous intermittent and fluctuating The heating pad can be turned on and off with a single button and the temperature can be adjusted decrease-increase To prevent overheating and tissue damage a maximum temperature of 42 C was fixed on the control The inner padding is made of a material that protects both the massager and the heating pad from external factors and also serves as a seat The shape of the device is designed to ensure that the massager is in full contact with the waist when the pregnant woman sits on the ball The coating of the massage chair and heating pad is made of cleanable material suitable for hospital use
Materials and Methods The multifunctional birthing ball will support the active movements of the pregnant woman as well as warming the perineum while providing lumbar and back massage The multifunctional birthing ball was developed by researchers and manufactured by the Near East University 3D Lab The bottom of the ball is made of flexible and explosion-proof material filled with air The purpose of the ball is to enable the pregnant woman to make swinging and bouncing movements during active labor The massager and heating pad will be controlled by a single electronic circuit Three different massage modes can be selected continuous intermittent and fluctuating The heating pad can be turned on and off with a single button and the temperature can be adjusted decrease-increase To prevent overheating and tissue damage a maximum temperature of 42 C was fixed on the control The inner padding is made of a material that protects both the massager and the heating pad from external factors and also serves as a seat The shape of the device is designed to ensure that the massager is in full contact with the waist when the pregnant woman sits on the ball The coating of the massage chair and heating pad is made of cleanable material suitable for hospital use
Detailed Description:
This study was designed to experimentally investigate the effect of a multifunctional birthing ball on perineal pain sacral pain total duration of labor perineal tears and womens satisfaction with the birth experience during the first and second stages of labor in pregnant women who will deliver vaginally Pregnant women to be included in the experimental and control groups should meet the following criteria
First-time mothers
At term 37-42 weeks of gestation
Single fetal gestation
Cervical dilatation of 3 cm or greater
Expected spontaneous delivery
No pregnancy complications or systemic diseases
No history of cephalopelvic disproportion placenta previa placental abruption or fetal distress
Willingness to participate in the study
Age between 18 and 35 years
Experimental Intervention Participants in the experimental group will receive massages using a multifunctional birthing ball during the first stage of labor Massages will be administered for 30 minutes each at the end of the latent active and transition phases cervical dilatation 3-4 cm 5-7 cm and 8-10 cm respectively Visual Analog Scale VAS scores will be evaluated three times in each phase to assess low back pain In the control group VAS scores will be evaluated three times without massage application for the same periods
Perineal Heating Application
Perineal heating application will be initiated when the second stage of labor begins and will continue until delivery The heating application will consist of 20 minutes of application followed by 20 minutes of tissue rest VAS scores will be evaluated two times during these stages to determine perineal pain In the control group VAS scores will be evaluated twice without heating application for the same periods
Postpartum Evaluation
During the postpartum period each participant will complete a 30-question Postpartum Interview Form that will address questions related to the status of perineal integrity at the end of labor overall childbirth experience and satisfaction with the birth process Additionally each participant will complete the Birth Satisfaction Scale - a 30-item questionnaire designed to assess the womans satisfaction with her birth experience
First-time mothers
At term 37-42 weeks of gestation
Single fetal gestation
Cervical dilatation of 3 cm or greater
Expected spontaneous delivery
No pregnancy complications or systemic diseases
No history of cephalopelvic disproportion placenta previa placental abruption or fetal distress
Willingness to participate in the study
Age between 18 and 35 years
Experimental Intervention Participants in the experimental group will receive massages using a multifunctional birthing ball during the first stage of labor Massages will be administered for 30 minutes each at the end of the latent active and transition phases cervical dilatation 3-4 cm 5-7 cm and 8-10 cm respectively Visual Analog Scale VAS scores will be evaluated three times in each phase to assess low back pain In the control group VAS scores will be evaluated three times without massage application for the same periods
Perineal Heating Application
Perineal heating application will be initiated when the second stage of labor begins and will continue until delivery The heating application will consist of 20 minutes of application followed by 20 minutes of tissue rest VAS scores will be evaluated two times during these stages to determine perineal pain In the control group VAS scores will be evaluated twice without heating application for the same periods
Postpartum Evaluation
During the postpartum period each participant will complete a 30-question Postpartum Interview Form that will address questions related to the status of perineal integrity at the end of labor overall childbirth experience and satisfaction with the birth process Additionally each participant will complete the Birth Satisfaction Scale - a 30-item questionnaire designed to assess the womans satisfaction with her birth experience
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None