Trial Outcomes & Findings for Non-pharmacological Resources in Assisting Labor (NCT NCT01389128)
NCT ID: NCT01389128
Last Updated: 2019-07-19
Results Overview
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)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
ten hours
Results posted on
2019-07-19
Participant Flow
Participant milestones
| Measure |
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
|
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;
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
|
Overall Study
COMPLETED
|
35
|
34
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
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
|
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;
|
|---|---|---|
|
Overall Study
Fetal distress
|
1
|
0
|
|
Overall Study
Cervix dilation stop
|
1
|
2
|
|
Overall Study
Rapid labor evolution
|
3
|
2
|
|
Overall Study
Intolerance to procedure
|
0
|
2
|
Baseline Characteristics
Non-pharmacological Resources in Assisting Labor
Baseline characteristics by cohort
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
21.85 years
STANDARD_DEVIATION 4.22 • n=93 Participants
|
20.60 years
STANDARD_DEVIATION 4.14 • n=4 Participants
|
20.72 years
STANDARD_DEVIATION 4.18 • n=27 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
BMI
|
28.4 kilograms per square meter
STANDARD_DEVIATION 5.36 • n=93 Participants
|
26.9 kilograms per square meter
STANDARD_DEVIATION 3.72 • n=4 Participants
|
27.65 kilograms per square meter
STANDARD_DEVIATION 4.54 • n=27 Participants
|
|
School degree
Elementary School
|
13 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
School degree
High School
|
24 Participants
n=93 Participants
|
25 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
School degree
College degree
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Marital status
single
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
|
Marital status
married
|
11 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
25 Participants
n=27 Participants
|
|
Marital status
stable union
|
23 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Preparation for labour
yes
|
10 participants
n=93 Participants
|
11 participants
n=4 Participants
|
21 participants
n=27 Participants
|
|
Preparation for labour
no
|
30 participants
n=93 Participants
|
29 participants
n=4 Participants
|
59 participants
n=27 Participants
|
|
Presence of partner
|
40 Participants
n=93 Participants
|
40 Participants
n=4 Participants
|
80 Participants
n=27 Participants
|
|
Occupation
unemployed
|
23 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
52 Participants
n=27 Participants
|
|
Occupation
employed
|
17 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: ten hoursThe 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)
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Pain Relief
Phase I - Before
|
79.5 millimeters
Standard Deviation 18.1
|
73.8 millimeters
Standard Deviation 16.2
|
|
Pain Relief
Phase I - After
|
71.0 millimeters
Standard Deviation 35.0
|
51.7 millimeters
Standard Deviation 19.5
|
|
Pain Relief
Phase II - Before
|
75.6 millimeters
Standard Deviation 40.8
|
83.6 millimeters
Standard Deviation 15.8
|
|
Pain Relief
Phase II - After
|
36.3 millimeters
Standard Deviation 39.7
|
67.3 millimeters
Standard Deviation 24.3
|
|
Pain Relief
Phase III - Before
|
75.9 millimeters
Standard Deviation 37.0
|
96.4 millimeters
Standard Deviation 8.5
|
|
Pain Relief
Phase III - After
|
54.1 millimeters
Standard Deviation 34.2
|
60.6 millimeters
Standard Deviation 25.5
|
SECONDARY outcome
Timeframe: 10 hoursAmount of minutes, from admission to labor.
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Evolution of Labor
|
492 minutes
Standard Deviation 35
|
382 minutes
Standard Deviation 24
|
SECONDARY outcome
Timeframe: 10 hoursMean uterine cervical dilation at the moment the patient requested analgesia for pain relief. Data obtained from medical record
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Moment That Women Requested Analgesia During the Active Phase of Labor
|
6 centimeter
Standard Deviation 1
|
8 centimeter
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: 10 hoursDetermine the number of women who where submitted to pharmacological analgesia, either prescribed by the attending physician ou requested by the patient herself.
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Number of Women Who Received Pharmacological Analgesia
|
37 Participants
|
34 Participants
|
SECONDARY outcome
Timeframe: 10 hoursType of delivery at the end of the active phase of labor.
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Type of Delivery
Vaginal
|
30 Participants
|
35 Participants
|
|
Type of Delivery
C-Section
|
10 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 10 hoursNumber and type of neonatal complications as reported in medical chart
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Number of Participants Whose Neonates Had:
Fetal respiratory distress
|
6 Participants
|
0 Participants
|
|
Number of Participants Whose Neonates Had:
No complications
|
33 Participants
|
40 Participants
|
|
Number of Participants Whose Neonates Had:
Shoulder dystocia
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 10 hoursNumber and type of maternal complications as reported in medical chart
Outcome measures
| Measure |
Control Group
n=40 Participants
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
|
Intervention Group
n=40 Participants
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;
|
|---|---|---|
|
Number of Participants With:
Rapid evolution of labor
|
3 Participants
|
2 Participants
|
|
Number of Participants With:
Hypotension
|
1 Participants
|
0 Participants
|
|
Number of Participants With:
Dilation stop
|
6 Participants
|
3 Participants
|
|
Number of Participants With:
Fetal descent stop
|
3 Participants
|
1 Participants
|
|
Number of Participants With:
Intrapartum hemorhage
|
0 Participants
|
1 Participants
|
|
Number of Participants With:
No complications
|
27 Participants
|
33 Participants
|
Adverse Events
Control Group
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control Group
n=40 participants at risk
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
|
Intervention Group
n=40 participants at risk
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;
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Neonate complications
|
17.5%
7/40 • Number of events 7
|
0.00%
0/40
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place