Labour Pain
Conditions
Keywords
labor, pain, massage, natural birth
Brief summary
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.
Detailed description
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%.
Interventions
OTHERNon-pharmacological resources
A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: * Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes; * Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and, * Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.
OTHERRoutine care
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.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
- Agreed to participate in the study after reading and signing the consent form; * Primigravida; * Pregnancy only; * Gestational age ≥ 37 weeks; * Presentation fetal head * Chorioamniotic intact membranes * Working with spontaneous onset of labor * Admission at the beginning of active phase dilation (4-5 cm) * Lack of maternal and fetal pathologies * Literacy - primary education * Absence of cognitive problems
Exclusion criteria
* Pregnant women admitted for induction of labor * Rupture premature or early of chorioamniotic membranes * Use of uterotonic drugs before the active phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Relief | ten hours | 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: * Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) * Phase II: 5-6cm of cervical dilation (lumbosacral massage) * Phase III: 7cm or higher cervical dilation (warm shower) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Moment That Women Requested Analgesia During the Active Phase of Labor | 10 hours | Mean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record |
| Number of Women Who Received Pharmacological Analgesia | 10 hours | Determine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself. |
| Evolution of Labor | 10 hours | Amount of minutes, from admission to labor. |
| Number of Participants Whose Neonates Had: | 10 hours | Number and type of neonatal complications as reported in medical chart |
| Number of Participants With: | 10 hours | Number and type of maternal complications as reported in medical chart |
| Type of Delivery | 10 hours | Type of delivery at the end of the active phase of labor. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 40 |
| 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; | 40 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cervix dilation stop | 1 | 2 |
| Overall Study | Fetal distress | 1 | 0 |
| Overall Study | Intolerance to procedure | 0 | 2 |
| Overall Study | Rapid labor evolution | 3 | 2 |
Baseline characteristics
| Characteristic | Control Group | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 21.85 years STANDARD_DEVIATION 4.22 | 20.60 years STANDARD_DEVIATION 4.14 | 20.72 years STANDARD_DEVIATION 4.18 |
| BMI | 28.4 kilograms per square meter STANDARD_DEVIATION 5.36 | 26.9 kilograms per square meter STANDARD_DEVIATION 3.72 | 27.65 kilograms per square meter STANDARD_DEVIATION 4.54 |
| Marital status married | 11 Participants | 14 Participants | 25 Participants |
| Marital status single | 6 Participants | 3 Participants | 9 Participants |
| Marital status stable union | 23 Participants | 23 Participants | 46 Participants |
| Occupation employed | 17 Participants | 11 Participants | 28 Participants |
| Occupation unemployed | 23 Participants | 29 Participants | 52 Participants |
| Preparation for labour no | 30 participants | 29 participants | 59 participants |
| Preparation for labour yes | 10 participants | 11 participants | 21 participants |
| Presence of partner | 40 Participants | 40 Participants | 80 Participants |
| School degree College degree | 3 Participants | 4 Participants | 7 Participants |
| School degree Elementary School | 13 Participants | 11 Participants | 24 Participants |
| School degree High School | 24 Participants | 25 Participants | 49 Participants |
| Sex: Female, Male Female | 40 Participants | 40 Participants | 80 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 7 / 40 | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
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: * Phase I: 4-5cm of cervical dilation (pelvic mobility in exercise ball) * Phase II: 5-6cm of cervical dilation (lumbosacral massage) * Phase III: 7cm or higher cervical dilation (warm shower)
Time frame: ten hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Pain Relief | Phase I - After | 71.0 millimeters | Standard Deviation 35 |
| Control Group | Pain Relief | Phase II - After | 36.3 millimeters | Standard Deviation 39.7 |
| Control Group | Pain Relief | Phase III - Before | 75.9 millimeters | Standard Deviation 37 |
| Control Group | Pain Relief | Phase I - Before | 79.5 millimeters | Standard Deviation 18.1 |
| Control Group | Pain Relief | Phase III - After | 54.1 millimeters | Standard Deviation 34.2 |
| Control Group | Pain Relief | Phase II - Before | 75.6 millimeters | Standard Deviation 40.8 |
| Intervention Group | Pain Relief | Phase III - After | 60.6 millimeters | Standard Deviation 25.5 |
| Intervention Group | Pain Relief | Phase I - Before | 73.8 millimeters | Standard Deviation 16.2 |
| Intervention Group | Pain Relief | Phase I - After | 51.7 millimeters | Standard Deviation 19.5 |
| Intervention Group | Pain Relief | Phase II - Before | 83.6 millimeters | Standard Deviation 15.8 |
| Intervention Group | Pain Relief | Phase III - Before | 96.4 millimeters | Standard Deviation 8.5 |
| Intervention Group | Pain Relief | Phase II - After | 67.3 millimeters | Standard Deviation 24.3 |
Secondary
Evolution of Labor
Amount of minutes, from admission to labor.
Time frame: 10 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Evolution of Labor | 492 minutes | Standard Deviation 35 |
| Intervention Group | Evolution of Labor | 382 minutes | Standard Deviation 24 |
p-value: <0.01Chi-squared
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
Time frame: 10 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Moment That Women Requested Analgesia During the Active Phase of Labor | 6 centimeter | Standard Deviation 1 |
| Intervention Group | Moment That Women Requested Analgesia During the Active Phase of Labor | 8 centimeter | Standard Deviation 0.8 |
Secondary
Number of Participants Whose Neonates Had:
Number and type of neonatal complications as reported in medical chart
Time frame: 10 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Number of Participants Whose Neonates Had: | Shoulder dystocia | 1 Participants |
| Control Group | Number of Participants Whose Neonates Had: | Fetal respiratory distress | 6 Participants |
| Control Group | Number of Participants Whose Neonates Had: | No complications | 33 Participants |
| Intervention Group | Number of Participants Whose Neonates Had: | Shoulder dystocia | 0 Participants |
| Intervention Group | Number of Participants Whose Neonates Had: | Fetal respiratory distress | 0 Participants |
| Intervention Group | Number of Participants Whose Neonates Had: | No complications | 40 Participants |
Secondary
Number of Participants With:
Number and type of maternal complications as reported in medical chart
Time frame: 10 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Number of Participants With: | Rapid evolution of labor | 3 Participants |
| Control Group | Number of Participants With: | Dilation stop | 6 Participants |
| Control Group | Number of Participants With: | No complications | 27 Participants |
| Control Group | Number of Participants With: | Fetal descent stop | 3 Participants |
| Control Group | Number of Participants With: | Hypotension | 1 Participants |
| Control Group | Number of Participants With: | Intrapartum hemorhage | 0 Participants |
| Intervention Group | Number of Participants With: | Hypotension | 0 Participants |
| Intervention Group | Number of Participants With: | No complications | 33 Participants |
| Intervention Group | Number of Participants With: | Rapid evolution of labor | 2 Participants |
| Intervention Group | Number of Participants With: | Intrapartum hemorhage | 1 Participants |
| Intervention Group | Number of Participants With: | Dilation stop | 3 Participants |
| Intervention Group | Number of Participants With: | Fetal descent stop | 1 Participants |
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.
Time frame: 10 hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Women Who Received Pharmacological Analgesia | 37 Participants |
| Intervention Group | Number of Women Who Received Pharmacological Analgesia | 34 Participants |
Secondary
Type of Delivery
Type of delivery at the end of the active phase of labor.
Time frame: 10 hours
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Type of Delivery | Vaginal | 30 Participants |
| Control Group | Type of Delivery | C-Section | 10 Participants |
| Intervention Group | Type of Delivery | Vaginal | 35 Participants |
| Intervention Group | Type of Delivery | C-Section | 5 Participants |
p-value: 0.68Chi-squared