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The Effect of Birth Ball and Birth Dance Applied in the First Stage of Labor on Some Parameters

Primary Purpose

Pain, Labor, Satisfaction, Patient

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental (birth ball)
Experimental (birth dance)
Sponsored by
Amasya University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Pain, Labor focused on measuring birth, birth dance, birth ball, pregnant

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Experimental (birth ball)

    Experimental (birth dance)

    control group

    Arm Description

    Group B Meeting The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured After the routine maintenance of the hospital is carried out in the latent phase, the researcher will first introduce the birthing ball to the pregnant women and the movements to be performed will be demonstrated by the researcher. 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. When the perineum is crowned, the pregnant woman will be taken to the table. SEMSNB will be applied within 1-4 hours after birth.

    Group C Meeting The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured The environment will be made suitable The pregnant woman will be asked to wear slippers that make her feel comfortable. Pregnant will be given training on how to perform the birth dance during the latent phase. VCS and VAS will be applied. Birth dance practice will be started on the pregnant woman starting from the active phase. Starting from the active phase, the partograph will be recorded. Birth dance cervical dilation will be performed for 20 minutes every hour, in the range of 5-8 cm. At the end of the active phase, VCS and VAS will be applied again. The researcher will be with the pregnant woman throughout the application and labor. When perineum is crowned, the pregnant woman will be taken to the delivery table. SEMSNB will be applied within 1-4 hours after birth.

    Midwifery Interventions Made to the Control Group The pregnant woman will be greeted politely. The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured An introductory information form will be filled out. Routine monitoring and care will be provided by the medical staff working in the delivery room. At the end of each phase (latent, active), GKS and SCS will be applied once. EFM (Electronic Fetal Monitoring) will be applied in each phase. Child Heart Sound (CHS) will be listened to every half hour and recorded on the partograph. Cervical changes will be evaluated with bimanual examination and recorded on the partograph. When the perineum is crowned, the pregnant woman will be taken to the table. NDAMDÖ will be applied to women taken to the postpartum room within a period of 1-4 hours.

    Outcomes

    Primary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2023
    Last Updated
    October 10, 2023
    Sponsor
    Amasya University
    Collaborators
    Ataturk University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06085820
    Brief Title
    The Effect of Birth Ball and Birth Dance Applied in the First Stage of Labor on Some Parameters
    Official Title
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 6, 2023 (Anticipated)
    Primary Completion Date
    April 30, 2024 (Anticipated)
    Study Completion Date
    November 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Amasya University
    Collaborators
    Ataturk University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pain, Labor, Satisfaction, Patient
    Keywords
    birth, birth dance, birth ball, pregnant

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    There will be three groups in total in the study, one control and two experimental groups.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental (birth ball)
    Arm Type
    Experimental
    Arm Description
    Group B Meeting The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured After the routine maintenance of the hospital is carried out in the latent phase, the researcher will first introduce the birthing ball to the pregnant women and the movements to be performed will be demonstrated by the researcher. 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. When the perineum is crowned, the pregnant woman will be taken to the table. SEMSNB will be applied within 1-4 hours after birth.
    Arm Title
    Experimental (birth dance)
    Arm Type
    Experimental
    Arm Description
    Group C Meeting The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured The environment will be made suitable The pregnant woman will be asked to wear slippers that make her feel comfortable. Pregnant will be given training on how to perform the birth dance during the latent phase. VCS and VAS will be applied. Birth dance practice will be started on the pregnant woman starting from the active phase. Starting from the active phase, the partograph will be recorded. Birth dance cervical dilation will be performed for 20 minutes every hour, in the range of 5-8 cm. At the end of the active phase, VCS and VAS will be applied again. The researcher will be with the pregnant woman throughout the application and labor. When perineum is crowned, the pregnant woman will be taken to the delivery table. SEMSNB will be applied within 1-4 hours after birth.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    Midwifery Interventions Made to the Control Group The pregnant woman will be greeted politely. The researcher will introduce himself/herself, provide information about the research and obtain verbal and written consent. Privacy will be ensured An introductory information form will be filled out. Routine monitoring and care will be provided by the medical staff working in the delivery room. At the end of each phase (latent, active), GKS and SCS will be applied once. EFM (Electronic Fetal Monitoring) will be applied in each phase. Child Heart Sound (CHS) will be listened to every half hour and recorded on the partograph. Cervical changes will be evaluated with bimanual examination and recorded on the partograph. When the perineum is crowned, the pregnant woman will be taken to the table. NDAMDÖ will be applied to women taken to the postpartum room within a period of 1-4 hours.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental (birth ball)
    Intervention Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental (birth dance)
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Verbal Category Scale-VCS
    Description
    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.
    Time Frame
    pre-intervention
    Title
    Visual Comparison Scale (VAS)
    Description
    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.
    Time Frame
    pre-intervention
    Title
    partograph
    Description
    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.
    Time Frame
    up to birth
    Title
    Evaluation of birth ball-VCS
    Description
    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.
    Time Frame
    immediately after the intervention
    Title
    Evaluation of birth ball-satisfaction
    Description
    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.
    Time Frame
    up to 1-4 hours postpartum
    Title
    Evaluation of birth dance-satisfaction
    Description
    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.
    Time Frame
    up to 1-4 hours postpartum
    Title
    Evaluation of birth ball-VAS
    Description
    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.
    Time Frame
    immediately after the intervention
    Title
    Evaluation of birth dance-VCS
    Description
    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.
    Time Frame
    immediately after the intervention
    Title
    Evaluation of birth dance-VAS
    Description
    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.
    Time Frame
    immediately after the intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Only women will be included in the study.
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Özlem Arı
    Phone
    05076402512
    Email
    ozlem.ari@amasya.edu.tr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meral Kılıç
    Organizational Affiliation
    Ataturk University
    Official's Role
    Study Director

    12. IPD Sharing Statement

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    The Effect of Birth Ball and Birth Dance Applied in the First Stage of Labor on Some Parameters

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