- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06085820
The Effect of Birth Ball and Birth Dance Applied in the First Stage of Labor on Some Parameters
The Effect of Birth Ball and Bırth Dance Applied in The First Stage of Labor on Pain, Type of Birth, Maternal Satisfactıon Ond Duration of Labor
Aim: The study was conducted to investigate the effect of birth ball and birth dance practices applied in the first stage of labour on pain, mode of delivery, maternal satisfaction and duration of labour. Material and Method: This study was conducted as a randomised controlled clinical trial between July 2023 and December 2024. The population of the study consisted of pregnant women who applied to Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital Delivery Department between January 2024 and August 2024. The sample group consisted of a total of 104 primiparous pregnant women, 35 A (round ball group), 33 B (birth dance group) and 36 C (control group), who met the inclusion criteria and were determined by power analysis. Data were collected by using 'Descriptive Information Form', 'Verbal Category Scale', 'Visual Analogue Scale', 'Partograph' and 'Maternal Satisfaction in Childbirth Assessment Scale'. Results: In active phase of labour, birth ball and birth dance practice caused a significant decrease in pain perceptions of pregnant women (p<0.05). It was determined that level of cervical dilatation progressed faster in pregnant women who were administered a round birth ball during labour compared to the other groups. It was also determined that application of birth ball and birth dance in labour accelerated level of fetal head descent in the active phase of labour, shortened duration of the active phase, affected the duration and number of contractions and did not affect labour satisfaction according to the cut-off score of the Maternal Satisfaction in Childbirth Assessment Scale.
Conclusion: The application of birth ball and birth dance in the active phase of labour was found to reduce labour pain, accelerate the level of fetal head descent, shorten duration of the active phase, and affect duration and number of contractions.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Birth ball and birth dance practices are among the primary methods used to provide freedom of movement to women during birth. These methods enable the woman to benefit from all the opportunities provided by the upright position and are important in the normal course of action. One of the main points of birth ball and birth dance practices is squatting. Squatting is a posture in which the legs are opened to the sides and the knees are bent. This position facilitates birth by widening the pelvic outlet.
A birthing ball is one of the methods that help mothers cope with labor pain. Exercise with a birthing ball is considered a useful, non-pharmacological strategy The main advantages of birthing ball exercise during pregnancy include postural corrections, relaxation, stretching and strengthening muscles. Sekendiz et al stated that movements performed with a birth ball increase the strength, resistance, flexibility and balance of the trunk, waist and quadriceps muscles. The use of a birth ball and similar non-pharmacological interventions reduce the need for epidural anesthesia, episiotomy and interventional birth. However, no side effects on mother and baby health have been reported
The birthing ball, also known as the Swiss ball and the Petzi ball, was developed in 1963 and has been used in physical applications of neurodevelopmental therapy. Perez and Simkin introduced the birthing ball as a birthing tool to professional birth assistants, midwives, nurses and students who provide childbirth education since the 1980s. Perez (2001) stated that the use of a birth ball during pregnancy and birth is physically beneficial.
Birth dance is one of the non-pharmacological practices that allows freedom of massage and position changes with the support of the spouse/partner. During the birth dance, the pregnant woman puts her hands on her partner's shoulders and performs pelvic tilt movements accompanied by music; His back and sacrum are massaged by his partner.
Dance, one of the non-pharmacological methods used in birth; It may be a way to reduce technological and medical interventions during labor while also promoting the progression of labor. In many cultures, an upright position during labor is common. An upright position and mobility during labor is recommended because this is likely to improve maternal and fetal circulation while also It also increases maternal comfort.
There are studies on birth ball and birth dance in the relevant literature. However, no study comparing birth dance and birth ball applications has been found in the literature.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Center
-
Amasya, Center, Turkey, 05000
- Amasya University Sabuncuoglu Serefeddin Training and Research Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those who agree to participate in the research, are over 18 years old and speak Turkish,
- Primiparous pregnant women who do not have any physical or chronic disease and are in the latent phase,
- Pregnant women who do not have a risky pregnancy,
- 38-42. gestational age, singleton pregnant women,
- Absence of diagnosed fetal malformations,
- No medical problems at the beginning of the study,
- Amniotic membranes are not opened,
- Women who are at least primary school graduates will be included in the research.
Exclusion Criteria:
- Pregnant women who received epidural analgesia in the first stage of labor,
- Pregnant women whose labor lasts less than 3 hours will not be included in the study.
- In case of any complications or cesarean section, the sample will be removed from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
Midwifery Interventions Made to the Control Group
|
|
|
Experimental: Experimental (birth ball)
Group A
Starting from the active phase, movements will be performed for 20 minutes every hour. During the contraction, there will be a break until the contraction ends, and the pregnant woman will be given the opportunity to rest in a comfortable position. The same movements will be applied again. The partograph will be recorded. VAS and VCS will be applied.
|
It is a large and firm ball made of soft, thick plastic, inflated with air. It can be easily inflated and deflated, washable, available in different sizes (55-65-75 cm in diameter) and strong enough to carry weight up to 136 kg. When the literature was examined, it was seen that birth balls between 55-75cm were generally used in accordance with the intended use. Appropriate ball size will be determined by the participant's height. In order for the pregnant woman to continue balance exercises, she should be allowed to sit on the round birthing ball with her knees and hips at an angle of approximately 90°, with an upright spine. birth ball; It is performed in sitting (pelvic rocking movement, forward-backward and right-left rocking, forward-supported sitting, springing movement), kneeling and squatting (hugging the ball and pelvic rocking movement) positions. |
|
Experimental: Experimental (birth dance)
Group B
Birth dance practice will be started on the pregnant woman starting from the active phase.
SEMSNB will be applied within 1-4 hours after birth. |
Thanks to the birth dance, the expectant mother perceives less pain. In fact, it is known that a change in position is effective in the perception of pain. On the other hand, if the woman focuses on a point other than the pain during the act, it makes it easier for her to perceive the pain less. The low cost of this application increases its usability. The most appropriate time for the birth dance is from the active phase of the first phase of labor until the end of this phase . The expectant mother dances with rhythmic movements accompanied by soothing and soothing music with the help of a birth supporter (midwife, relative, spouse or partner). Optionally, sacral massage can be added to the birth dance. In fact, in addition to reducing the pain experienced through freedom of movement, upright position and massage, it is also aimed to provide emotional support to the woman. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Verbal Category Scale-VCS
Time Frame: pre-intervention
|
VCS allows the person to describe pain by choosing the most appropriate expression.
Using this scale, the pain experienced is categorized from mild to unbearable.
They are numbered on the scale as Mild (1), Disturbing (2), Severe (3), Very Severe (4) and Unbearable (5).
The patient is asked to choose the one that suits his/her condition from these options.
|
pre-intervention
|
|
Visual Comparison Scale (VAS)
Time Frame: pre-intervention
|
VAS is used to determine the patient's pain experience.
A 10 cm long ruler is used for this purpose.
At one end of this scale, there are "No Pain" categories and at the other end there are "Unbearable Pain" categories.
It has been stated in the literature that this scale is more sensitive and reliable than other unidimensional scales.
The patient is told that there are two end points and that he can mark any point he wishes among these points that is appropriate to the severity of his pain.
The distance between the beginning of no pain and the point marked by the patient is measured and recorded in centimeters.
|
pre-intervention
|
|
partograph
Time Frame: up to birth
|
A partograph is a graphic record on paper that shows the progress of labor and indicates maternal and fetal status.
It is helpful in recognizing cephalopelvic disproportion in labor that does not progress normally and in determining labor induction.
It is an early warning system for labor induction, termination of labor, and the decision for caesarean section.
|
up to birth
|
|
Evaluation of birth ball-VCS
Time Frame: immediately after the intervention
|
VCS allows the person to describe pain by choosing the most appropriate expression.
Using this scale, the pain experienced is categorized from mild to unbearable.
They are numbered on the scale as Mild (1), Disturbing (2), Severe (3), Very Severe (4) and Unbearable (5).
The patient is asked to choose the one that suits his/her condition from these options.
|
immediately after the intervention
|
|
Evaluation of birth ball-satisfaction
Time Frame: up to 1-4 hours postpartum
|
Mother Satisfaction Assessment Scale in Normal Birth: It was developed by Güngör and Beji and consists of 43 items and 10 subscales.
Thirteen items (7,8,9,10,19,20,21,22,35,36,38,41,42) are reverse scored.
The scale is a 5-point Likert type.
It is scored as "1- I disagree, 2- I partially agree, 3- I am undecided, 4- I agree and 5- I strongly agree."
As the total score from the scale increases, mothers' satisfaction level with the care they received in the hospital during normal birth increases.
|
up to 1-4 hours postpartum
|
|
Evaluation of birth dance-satisfaction
Time Frame: up to 1-4 hours postpartum
|
Mother Satisfaction Assessment Scale in Normal Birth: It was developed by Güngör and Beji and consists of 43 items and 10 subscales.
Thirteen items (7,8,9,10,19,20,21,22,35,36,38,41,42) are reverse scored.
The scale is a 5-point Likert type.
It is scored as "1- I disagree, 2- I partially agree, 3- I am undecided, 4- I agree and 5- I strongly agree."
As the total score from the scale increases, mothers' satisfaction level with the care they received in the hospital during normal birth increases.
|
up to 1-4 hours postpartum
|
|
Evaluation of birth ball-VAS
Time Frame: immediately after the intervention
|
Visual Comparison Scale (VAS): VAS is used to determine the patient's pain experience.
A 10 cm long ruler is used for this purpose.
At one end of this scale, there are "No Pain" categories and at the other end there are "Unbearable Pain" categories.
It has been stated in the literature that this scale is more sensitive and reliable than other unidimensional scales.
The patient is told that there are two end points and that he can mark any point he wishes among these points that is appropriate to the severity of his pain.
The distance between the beginning of no pain and the point marked by the patient is measured and recorded in centimeters.
|
immediately after the intervention
|
|
Evaluation of birth dance-VCS
Time Frame: immediately after the intervention
|
VCS allows the person to describe pain by choosing the most appropriate expression.
Using this scale, the pain experienced is categorized from mild to unbearable.
They are numbered on the scale as Mild (1), Disturbing (2), Severe (3), Very Severe (4) and Unbearable (5).
The patient is asked to choose the one that suits his/her condition from these options.
|
immediately after the intervention
|
|
Evaluation of birth dance-VAS
Time Frame: immediately after the intervention
|
Visual Comparison Scale (VAS): VAS is used to determine the patient's pain experience.
A 10 cm long ruler is used for this purpose.
At one end of this scale, there are "No Pain" categories and at the other end there are "Unbearable Pain" categories.
It has been stated in the literature that this scale is more sensitive and reliable than other unidimensional scales.
The patient is told that there are two end points and that he can mark any point he wishes among these points that is appropriate to the severity of his pain.
The distance between the beginning of no pain and the point marked by the patient is measured and recorded in centimeters.
|
immediately after the intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Meral Kılıç, Atatürk University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ozlemarı003
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Satisfaction, Patient
-
Shaukat Khanum Memorial Cancer Hospital & Research...CompletedSatisfaction, Patient | SatisfactionPakistan
-
Duke UniversityCompletedPatient Satisfaction | Clinician SatisfactionUnited States
-
Universitair Ziekenhuis BrusselWithdrawnPatient Satisfaction | Patient PreferenceBelgium
-
Cedars-Sinai Medical CenterTerminated
-
HaEmek Medical Center, IsraelUnknownPatient Satisfaction | Patient Compliance
-
Acibadem UniversityCompletedPatient Satisfaction | Patient Relations, NurseTurkey
-
Methodist Health SystemCompletedSatisfaction, PatientUnited States
-
University Hospital, ToulouseCompletedSatisfaction, PatientFrance
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedPatient Satisfaction | Bowel Preparation | Patient ExperienceTurkey
-
Dr Abdurrahman Yurtaslan Ankara Oncology Training...CompletedPatient Satisfaction | Bowel Preparation | Patient ExperienceTurkey
Clinical Trials on Experimental (birth ball)
-
Selcuk UniversityCompletedPain | Labor Pain | SatisfactionTurkey
-
Gaziantep Islam Science and Technology UniversityCompletedSatisfaction, Patient | Labor Pain | Labor FastTurkey
-
Selcuk UniversityCompletedLabor Pain | Childbirth Problems | Birth DisorderTurkey
-
Fatma DünmezCompletedSatisfaction, Patient | Labor Pain | Labor FastTurkey
-
Inonu UniversityCompleted
-
Istanbul University - CerrahpasaNot yet recruitingPerineal Pain | Birth Satisfaction | Perineal Laceration, Tear, or Rupture During Delivery
-
Dr. Sobia HasanCompletedDiabetic Nephropathy Type 2Pakistan
-
Zonguldak Bulent Ecevit UniversityNot yet recruitingEndometrial Hyperplasia | Endometrial Neoplasms | Biopsy Wound
-
Yu-Jui FengActive, not recruitingAssessing the Effect of Acupoint Massage on Pain and Anxiety in Patients Undergoing Surgery Under Local AnesthesiaTaiwan