Pain
Conditions
Keywords
Labor, vaginal delivery, pain
Brief summary
Although there are studies that investigated the use of non-pharmacological pain relief and correction of dystocia during labor, there are few randomized controlled trials, especially related to combined protocols that use such resources. The use of combined protocols could potentiate the effects of resource use alone, evidencing the need for more studies related to the topic, as well as the effects of these methods on maternal and perinatal outcomes. In order to verify the effect of these methods in various stages of labor, childbirth and immediately becomes necessary to conduct a randomized controlled trial well-designed and adequate sample size that can make the future systematic reviews that can definitely conclude about the potential effectiveness of protocols that use combined resources to non-pharmacological pain relief in labor. Aim of our study is to evaluate the effects of a protocol of non-pharmacological resources on pain of pregnant women in the active phase of cervical dilatation and compared with controls.
Detailed description
Labor is a natural physiologic process triggered by mechanical and hormonal events that promote uterine contractions. Several non-pharmacological resources can be used during labor, such as relaxation techniques and ongoing support, maternal mobility, walking, breathing exercises, massage, Swiss ball, stool, shower, whirlpool and application of transcutaneous electrical stimulation (ENT .) Despite the role of physiotherapy in labor is not an established practice in public hospitals, it is expected that with the evidence of the benefits of non-pharmacological resources at this time, managers and health professionals validate the importance of interdisciplinary care in pregnancy - postpartum. The aim of this study is to evaluate the effects of resources on non-pharmacological pain of mothers in the active phase of cervical dilatation when compared to controls. This research is a randomized, controlled clinical study that includes pregnant women randomly assigned to two groups: Intervention Group (IG) women who will use the following sequence features: ambulation (with cervical dilatation of 4 to 5 cm), alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) and a shower (with dilation\> 7 cm) for 40 minutes each resource; Control Group (CG) women who will not use any physical therapy resource, are subject only to routine procedures of maternity care . For pain assessment will use the Visual Analogue Scale - VAS and the body diagram of the location and spatial distribution of pain. Results are presented in tables and graphs made to better understand the comparisons between the control and intervention. To compare maternal morbidity, obstetric and neonatal between groups will be used Fisher's exact test or chi-square.
Interventions
OTHERUse of non-pharmacological
Other: Non-pharmacological resources A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows: * Walking (with cervical dilation between 4 and 5 cm) * Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) * Shower (with dilation\> 7 cm);
OTHEROther: Routine care
Other: Routine 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
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
15 Years to 30 Years
Healthy volunteers
Yes
Inclusion criteria
* Agreement of the patient to participate in the study after reading and signing the consent form; * primigravida; * Pregnancy unique; * Gestational age\> 37 weeks; * fetal cephalic presentation; * chorioamniotic intact membranes; * spontaneous labor; * Admission to the beginning of the active phase of dilatation (4 cm cervical dilatation); * Dynamics between 2 and 4 uterine contractions in ten minutes; * Lack of maternal and fetal pathologies; * literate; * Absence of cognitive problems.
Exclusion criteria
Intolerance to non-pharmacological application of resources; * Increased pain by the woman that prevents the completion of the intervention; * Want to stop the intervention; * Suspected acute suffering; * Indication of cesarean section.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Suspected Fetal Distress, Between Groups | 10 hours | Evaluate the frequency of suspected fetal distress with the presence of meconium release. |
| Average Duration of the Expulsive Period When Compared to Groups | Starts with 10 centimeters of dilation until delivery | Assess the duration of the expulsion period and compare between groups |
| Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | 10 hours | Analyze and compare between the groups the types of dystocia. Dystocia: b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total. b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012). |
| Admission Numbers to a Neonatal Intensive Care Unit Between Groups. | 10 hours | Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram |
| Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. | 10 hours | Analyze and compare Apgar scores of the 1-min \>7 and 5-min \>7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn. Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions. |
| Number of Participants Who Requested Analgesia During the Active Phase of Childbirth | 10 hours | Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph. |
| The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | 10 hours | Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph. A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | 10 hours | Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record. |
| Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups. | immediately postpartum up to 2 days after childbirth | Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion) |
| The Number of Puerperal Infections Between Groups. | immediately postpartum up to 2 days after childbirth | Analyze and compare between the groups the number of puerperal infection |
| Moment of Rupture of the Chorioamniorex Between the Groups. | 10 hours | Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred. |
Countries
Brazil
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Active Comparator: Control Group 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.
Other: Routine care: Other: Routine 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. | 40 |
| Intervention Group Experimental: Intervention Group Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: Walking (with cervical dilation between 4 and 5 cm) Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm) Shower (with dilation\> 7 cm);
Use of non-pharmacological: Other: Non-pharmacological resources
A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
* Walking (with cervical dilation between 4 and 5 cm)
* Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)
* Shower (with dilation\> 7 cm); | 40 |
| Total | 80 |
Baseline characteristics
| Characteristic | Control | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous Age | 21.8 Years STANDARD_DEVIATION 4.22 | 22 Years STANDARD_DEVIATION 4.49 | 21.9 Years STANDARD_DEVIATION 4.35 |
| BMI | 28.4 Kilograms per square meter STANDARD_DEVIATION 5.36 | 28.6 Kilograms per square meter STANDARD_DEVIATION 4.94 | 28.5 Kilograms per square meter STANDARD_DEVIATION 5.15 |
| Height | 1.6 centimeters STANDARD_DEVIATION 0.07 | 1.6 centimeters STANDARD_DEVIATION 0.05 | 1.6 centimeters STANDARD_DEVIATION 0.06 |
| Marital status Married | 11 Participants | 8 Participants | 19 Participants |
| Marital status Single | 6 Participants | 13 Participants | 19 Participants |
| Marital status with partner | 23 Participants | 19 Participants | 42 Participants |
| Paid employment, | 17 Participants | 12 Participants | 29 Participants |
| PDW (pre-delivery weight) | 72.6 Kilograms per square meter STANDARD_DEVIATION 14.7 | 73.6 Kilograms per square meter STANDARD_DEVIATION 14.4 | 73.1 Kilograms per square meter STANDARD_DEVIATION 14.5 |
| PPW (pre-pregnancy weight) | 60.5 Kilograms per square meter STANDARD_DEVIATION 13 | 61.1 Kilograms per square meter STANDARD_DEVIATION 14.4 | 60.8 Kilograms per square meter STANDARD_DEVIATION 13.7 |
| School degree Elementary school | 13 Participants | 9 Participants | 22 Participants |
| School degree High school | 3 Participants | 4 Participants | 7 Participants |
| School degree Middle school | 24 Participants | 27 Participants | 51 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 | 0 / 40 | 2 / 40 |
| serious Total, serious adverse events | 0 / 40 | 0 / 40 |
Outcome results
Primary
Admission Numbers to a Neonatal Intensive Care Unit Between Groups.
Consider and compare neonatal admission to an intensive care unit between groups, attracted by the partogram
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Admission Numbers to a Neonatal Intensive Care Unit Between Groups. | 34 Participants |
| Intervention Group | Admission Numbers to a Neonatal Intensive Care Unit Between Groups. | 26 Participants |
Primary
Average Duration of the Expulsive Period When Compared to Groups
Assess the duration of the expulsion period and compare between groups
Time frame: Starts with 10 centimeters of dilation until delivery
Population: \[Not Specified\]
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Control Group | Average Duration of the Expulsive Period When Compared to Groups | 26 minutes |
| Intervention Group | Average Duration of the Expulsive Period When Compared to Groups | 18.5 minutes |
Primary
Frequency of Suspected Fetal Distress, Between Groups
Evaluate the frequency of suspected fetal distress with the presence of meconium release.
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Frequency of Suspected Fetal Distress, Between Groups | 2 Participants |
| Intervention Group | Frequency of Suspected Fetal Distress, Between Groups | 1 Participants |
Primary
Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7.
Analyze and compare Apgar scores of the 1-min \>7 and 5-min \>7, between groups. The APGAR score reflects the degree of fetal maturity and predicts healthy child development. It is a scale that can vary from 0 to 10, which 0 is a bad vitality and 10 is an excellent score. When the APGAR score is below 7, especially in the fifth minute, it is a warning sign to give special attention to the newborn. Newborns who have an Apgar in the first minute greater than 7, demonstrate good birth conditions.
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. | 1-min >7 | 31 Participants |
| Control Group | Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. | 5-min >7 | 40 Participants |
| Intervention Group | Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. | 1-min >7 | 30 Participants |
| Intervention Group | Number of Newborns With Apgar Scores of 1 and 5 Minutes, Less Than or Greater Than 7. | 5-min >7 | 40 Participants |
Primary
Number of Participants Who Requested Analgesia During the Active Phase of Childbirth
Average uterine cervical dilation of the patient who requested analgesia for pain relief. Data captured from the medical record by the partograph.
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Participants Who Requested Analgesia During the Active Phase of Childbirth | 37 Participants |
| Intervention Group | Number of Participants Who Requested Analgesia During the Active Phase of Childbirth | 35 Participants |
Primary
The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation.
Moment when a patient requested analgesia for pain relief. Data captured from the medical record by the partograph. A partogram was used, which is a printed document and allows the registration of all procedures and complications that occurred during labor, showing the conditions of the parturient and the fetus during this phase. This information is noted on a graph that makes it possible to assess all labor and duration. The doctor filled out the partograph and assessed the patient during labor, and she did not know which group belonged to the patient
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | 4- 5 cm | 19 Participants |
| Control Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | 6 - 7 cm | 16 Participants |
| Control Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | > 7 cm | 2 Participants |
| Control Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | Did not receive analgesia | 3 Participants |
| Intervention Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | Did not receive analgesia | 5 Participants |
| Intervention Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | 4- 5 cm | 1 Participants |
| Intervention Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | > 7 cm | 26 Participants |
| Intervention Group | The Moment in Centimeters That Women Requested Analgesia During the Active Phase of Childbirth, Analyzed by Cevical Dilation. | 6 - 7 cm | 8 Participants |
Primary
Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups
Analyze and compare between the groups the types of dystocia. Dystocia: b.1) Functional dystocia was considered when cervical dilation increased progressively, but with a speed less than 1 centimeter per hour; b.2) Secondary stop of the dilation was considered when there were 2 vaginal touches with the same cervical dilation in an interval of at least two hours, without being total. b.3) Secondary descent stop was considered when, with complete dilation of the uterine cervix, the same height of fetal descent was found in two successive touches with an interval of one hour (Protocol Royal College of Obstetricians and Gynecologists, 2012).
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | functional | 24 Participants |
| Control Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | secondary stop of dilation | 6 Participants |
| Control Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | Secondary descent stop | 4 Participants |
| Control Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | without dystocia | 6 Participants |
| Intervention Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | without dystocia | 14 Participants |
| Intervention Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | functional | 17 Participants |
| Intervention Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | Secondary descent stop | 6 Participants |
| Intervention Group | Types of Dystocia (Functional, Secondary Stop of Dilation and Fetal Offspring) Between Groups | secondary stop of dilation | 3 Participants |
Secondary
Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery).
Type of delivery (cesarean section, normal delivery with laceration, episiotomy, forceps and normal delivery), collected by the partograph found in the medical record.
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | normal birth | 3 Participants |
| Control Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | delivery with episiotomy | 17 Participants |
| Control Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | childbirth forcep | 4 Participants |
| Control Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | delivery with laceration | 6 Participants |
| Control Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | Cesarean section | 10 Participants |
| Intervention Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | delivery with laceration | 11 Participants |
| Intervention Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | Cesarean section | 6 Participants |
| Intervention Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | normal birth | 8 Participants |
| Intervention Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | childbirth forcep | 1 Participants |
| Intervention Group | Incidence in the Type of Delivery (Cesarean Section, Normal Delivery With Laceration, Episiotomy, Forceps and Normal Delivery). | delivery with episiotomy | 14 Participants |
Secondary
Moment of Rupture of the Chorioamniorex Between the Groups.
Observe if the groups had different types of cervical obstetric dilatation when a chorioamniorexis occurred.
Time frame: 10 hours
Population: \[Not Specified\]
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group | Moment of Rupture of the Chorioamniorex Between the Groups. | 7 centimeters |
| Intervention Group | Moment of Rupture of the Chorioamniorex Between the Groups. | 8 centimeters |
Secondary
Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups.
Evaluate and compare the presence of hemorrhage with hemodynamic repercussions between groups (requiring surgical approach and / or blood transfusion)
Time frame: immediately postpartum up to 2 days after childbirth
Population: \[Not Specified\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups. | 2 Participants |
| Intervention Group | Number of Puerperal Women Who Present Hemorrhage in the Immediate Puerperium With Hemodynamic Repercussions Between Groups. | 0 Participants |
Secondary
The Number of Puerperal Infections Between Groups.
Analyze and compare between the groups the number of puerperal infection
Time frame: immediately postpartum up to 2 days after childbirth
Population: \[Not Specified\]
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control Group | The Number of Puerperal Infections Between Groups. | 0 Participants |
| Intervention Group | The Number of Puerperal Infections Between Groups. | 0 Participants |