NCT06085820

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

October 17, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2024

Completed
Last Updated

February 4, 2025

Status Verified

January 1, 2025

Enrollment Period

8 months

First QC Date

October 3, 2023

Last Update Submit

January 31, 2025

Conditions

Keywords

birth dancebirth ballchildbirthlabor painmidwifesatisfaction

Outcome Measures

Primary Outcomes (9)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (3)

Experimental (birth ball)

EXPERIMENTAL

Group A * 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.

Behavioral: Experimental (birth ball)

Experimental (birth dance)

EXPERIMENTAL

Group B * 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.

Behavioral: Experimental (birth dance)

control group

NO INTERVENTION

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.

Interventions

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 ball)

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.

Experimental (birth dance)

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsOnly women will be included in the study.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amasya University Sabuncuoğlu Şerefeddin Training and Research Hospital

Amasya, Center, 05000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor PainPatient SatisfactionPersonal Satisfaction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Meral Kılıç

    Ataturk University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: There will be three groups in total in the study, one control and two experimental groups.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 17, 2023

Study Start

January 1, 2024

Primary Completion

August 31, 2024

Study Completion

December 10, 2024

Last Updated

February 4, 2025

Record last verified: 2025-01

Locations