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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06085820
Other study ID # ozlemari003
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date November 1, 2024

Study information

Verified date October 2023
Source Amasya University
Contact Özlem Ari
Phone 05076402512
Email ozlem.ari@amasya.edu.tr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Many non-pharmacological and pharmacological methods can be used in the management of labor pain. Considering the potential side effects on the mother and fetus, pharmacological methods may not be the first choice. Non-pharmacological methods can alleviate pain sensations in various ways, promoting women's well-being and sense of control in labor; Birth ball and birth dance are among the methods that help mothers cope with the pain process and birth. Birth ball is one of the auxiliary tools that make labor more comfortable. In the relevant literature, it has been reported that the birthing ball is beneficial for both pregnancy and birth processes. It is claimed that the birthing ball allows the woman to feel less pain, especially during contractions, and shortens the birth process. Fetal descent is accelerated with the effect of upright position and appropriate rotations. Thus, the mother's birth satisfaction will be increased. Birth satisfaction can be defined as meeting the mother's expectations from birth. Women with low birth satisfaction may develop a negative birth experience, perception of traumatic birth, postpartum depression or a delay in maternal attachment. Birth dance, which is an alternative practice to the birthing ball, can facilitate birth and positively affect maternal satisfaction with the change of position and freedom of movement it provides. It may also reduce the need for medical intervention by shortening the duration of labor. This study aims to examine the effects of birth ball and birth dance practices applied in the first stage of labor on pain, type of birth, maternal satisfaction and birth duration. This research will be conducted with primiparous pregnant women admitted to give birth at Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital Birth Room between November 2023 and April 2024. Personal Information Form, Verbal Category Scale, Visual Comparison Scale, Mother Satisfaction Evaluation Scale in Normal Birth and Partograph will be used to collect data.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 120
Est. completion date November 1, 2024
Est. primary completion date April 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Experimental (birth ball)
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 (birth dance)
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Amasya University Ataturk University

Outcome

Type Measure Description Time frame Safety issue
Primary Verbal Category Scale-VCS 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
Primary 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. pre-intervention
Primary partograph 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
Primary Evaluation of birth ball-VCS 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
Primary Evaluation of birth ball-satisfaction 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
Primary Evaluation of birth dance-satisfaction 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
Primary Evaluation of birth ball-VAS 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
Primary Evaluation of birth dance-VCS 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
Primary Evaluation of birth dance-VAS 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
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