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The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.
The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. After collecting the data, the groups are statistically analyzed using the linear regression model with mixed effects (fixed and random), taking into account a value of p <0.05 to obtain the statistical significance of 5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Active Comparator | Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. |
|
| Intervention Group | Experimental | Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-pharmacological resources | Other | A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Relief | The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:
| ten hours |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of Labor | Amount of minutes, from admission to labor. | 10 hours |
| Moment That Women Requested Analgesia During the Active Phase of Labor | Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record |
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Inclusion Criteria:- Agreed to participate in the study after reading and signing the consent form;
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Silvana M Quintana, professor | Faculty of Medicine of São Paulo University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Referral Center Women's Health - Mater | Ribeirão Preto | São Paulo | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15295342 | Background | Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008. | |
| 29289579 | Derived | Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. Control Group: Routine care of the institution performed by the staff, without the presence of the researcher |
| FG001 | Intervention Group | Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm); Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower; |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Low-risk primigravidae women admitted to the maternity ward in the active phase of labor.
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. Control Group: Routine care of the institution performed by the staff, without the presence of the researcher |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Relief | The Visual Analogue Scale - VAS - was used to measure the intensity of the pain described by the patients during the study. The patient was requested do mark a dot in a straight line, measuring 100mm, being a 0 (Zero) no pain and 100 the most intense pain. The researcher then would measure the estimated pain intensity in millimeters. The pain intensity was measured in all three phases before and after each procedure assigned to each group. The phases and their respective procedures were:
| Posted | Mean | Standard Deviation | millimeters | ten hours |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | Control Group (CG): Pregnant women who receive assistance from the routine CRSM MATER care, not being assisted by the physiotherapist, but that will be evaluated at the same time in the intervention group. Control Group: Routine care of the institution performed by the staff, without the presence of the researcher |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neonate complications | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment | When neonates suffered shoulder dystocia or respiratory distress |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Silvana Maria Quintana | University of São Paulo | +55(16)36022813 | quintana@fmrp.usp.br |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Routine care | Other | Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient. |
|
| 10 hours |
| Number of Women Who Received Pharmacological Analgesia | Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself. | 10 hours |
| Type of Delivery | Type of delivery at the end of the active phase of labor. | 10 hours |
| Number of Participants Whose Neonates Had: | Number and type of neonatal complications as reported in medical chart | 10 hours |
| Number of Participants With: | Number and type of maternal complications as reported in medical chart | 10 hours |
| Rapid labor evolution |
|
| Intolerance to procedure |
|
| Intervention Group |
Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm); Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower; |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kilograms per square meter |
|
| School degree | Count of Participants | Participants |
|
| Marital status | Count of Participants | Participants |
|
| Preparation for labour | Number | participants |
|
| Presence of partner | The measure refers to the number of participants who were accompanied by a partner or family member throughout labor | Count of Participants | Participants |
|
| Occupation | Count of Participants | Participants |
|
| OG001 | Intervention Group | Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm); Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower; |
|
|
| Secondary | Evolution of Labor | Amount of minutes, from admission to labor. | Posted | Mean | Standard Deviation | minutes | 10 hours |
|
|
|
|
| Secondary | Moment That Women Requested Analgesia During the Active Phase of Labor | Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record | Posted | Mean | Standard Deviation | centimeter | 10 hours |
|
|
|
| Secondary | Number of Women Who Received Pharmacological Analgesia | Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself. | Posted | Count of Participants | Participants | 10 hours |
|
|
|
| Secondary | Type of Delivery | Type of delivery at the end of the active phase of labor. | Posted | Count of Participants | Participants | 10 hours |
|
|
|
|
| Secondary | Number of Participants Whose Neonates Had: | Number and type of neonatal complications as reported in medical chart | Posted | Count of Participants | Participants | 10 hours |
|
|
|
| Secondary | Number of Participants With: | Number and type of maternal complications as reported in medical chart | Posted | Count of Participants | Participants | 10 hours |
|
|
|
| 0 |
| 40 |
| 7 |
| 40 |
| EG001 | Intervention Group | Intervention Group (IG): Pregnant women who receive the application the combination of non-pharmacological resources: standing upright pelvic mobility in the ball (4 to 5 cm), alternating stance associated with lumbosacral massage (5 and 6 cm) and shower (>or= 7 cm); Intervention Group: application of the combination of non-pharmacological resources: standing upright pelvic mobility in the ball, alternating stance associated with lumbosacral massage and shower; | 0 | 40 | 0 | 40 |
|
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| No complications |
|
| Dilation stop |
|
| Fetal descent stop |
|
| Intrapartum hemorhage |
|
| No complications |
|