Pain
Conditions
Keywords
pain, electric stimulation, nervous, transcutaneous, humanized childbirth
Brief summary
The objective of this research is to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (the use of lumbosacral TENS) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction.
Detailed description
Pain in the work appears as a subjective experience of interaction, involving a wide individual influences physiological, psychosocial and environmental factors, representing a major clinical signs of this phase. Despite presenting an important biological function, is now well established the need for their relief, since its persistence is associated with detrimental effects for both mother and fetus. Among non-pharmacological resources available, the investigators highlight the massage therapy that has shown positive effects in relieving pain and promote comfort of the mother. The objective of this research is to evaluate the efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for pain relief in the early active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Reference Center for Women's Health in Ribeirão Preto. Mothers will be divided into two groups (lumbosacral massage) and control (routine maternity) and will be evaluated before and after therapy, which corresponds to 30 minutes between 4-5 cm of cervical dilation. The evaluation will be performed by numerical category scale, location and Pain Diagram McGll Pain Questionnaire (short form). After the delivery will be a questionnaire of customer satisfaction. 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 for statistical significance of 5%.
Interventions
OTHERExperimental TENS
Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
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
* primigravida * literate * A single fetus in vertex position * Low-risk Pregnancy * From 37 weeks of gestation * Cervical dilatation between 4 and 5 cm with uterine dynamics normal for this stage * Labor in early spontaneous * No use of medications during the study period * Absence of cognitive or psychiatric problems * Intact membranes * No risk factors associated * Who wish to participate and signed the informed consent
Exclusion criteria
* TENS procedure intolerance * Use of any medication or procedure that promotes pain relief * Use of pacemaker
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Classification of Pain During Labor by Visual Analogue Scale | 30 minutes | To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia | 10 hours | Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records. |
| Duration From Start of Labor Until Birth | 10 hours | The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child. |
| Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor. | 10 hours | Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work. |
Countries
Brazil
Participant flow
Recruitment details
A randomized, controlled clinical noninferiority with an evaluator blind, comparative analysis of a study group and a control group, this estdo includes 46 patients, was developed in the Reference Center for Women's Health in Ribeirão Preto, São Paulo state Brazil, during the period September 2011 to February 2012 .
Pre-assignment details
283 women in labor were eligible, women were excluded because they did not participate 237 the inclusion criteria (first pregnancy, the position of a single fetus head, above 37 weeks, 4-5 cm of cervical dilatation, spontaneous onset of labor, not use of medications during the study period, intact membranes, and not associated with risk factors).
Participants by arm
| Arm | Count |
|---|---|
| Experimental TENS TENS Intervention Group(GIE) used for 30 minutes, during uterine contractions between 4-5 cm | 23 |
| Control Group Formed by mothers who will not use EAC to receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group. | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Control Group | Experimental TENS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 9 Participants | 12 Participants | 21 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 11 Participants | 25 Participants |
| Age, Continuous | 19.8 years STANDARD_DEVIATION 3.7 | 19.8 years STANDARD_DEVIATION 3.9 | 19.8 years STANDARD_DEVIATION 3.8 |
| Region of Enrollment Brazil | 23 participants | 23 participants | 46 participants |
| Sex: Female, Male Female | 23 Participants | 23 Participants | 46 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 / 23 | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 | 0 / 23 |
Outcome results
Primary
Classification of Pain During Labor by Visual Analogue Scale
To evaluate the Transcutaneous Electrical Nerve Stimulation as a resource for pain relief during the active phase of labor will be used the Visual Analogue Scale. Visual analogue scale (VAS): this scale, represented by a rule, the patient estimated pain on a scale of 100 mm (at one end labeled no pain associated with a score of 0 mm and at the other end worst pain imagined with a score 100 mm)
Time frame: 30 minutes
Population: We evaluated 46 patients, divided into 23 ENT group and 23 in the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental TENS | Classification of Pain During Labor by Visual Analogue Scale | 57.0 mm | Standard Deviation 23.4 |
| Control Group | Classification of Pain During Labor by Visual Analogue Scale | 72.1 mm | Standard Deviation 15.4 |
p-value: 0.01Mixed Models Analysis
Secondary
Duration From Start of Labor Until Birth
The length of time of labor, specified number of minutes since the opening of the partograph (early labor) until the birth of the child.
Time frame: 10 hours
Population: Analyzing the duration of labor
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental TENS | Duration From Start of Labor Until Birth | 393 min | Standard Deviation 139.4 |
| Control Group | Duration From Start of Labor Until Birth | 322 min | Standard Deviation 75.6 |
Secondary
Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia
Consider whether the TENS therapy during the active phase of labor could defer request for analgesia use for pain relief for pregnant women. The cervical dilation indicates the value in centimeters (0-10) of cervical dilation. Assessed on admission and during labor by doctors (according to the routine of the institution), as recorded in medical records.
Time frame: 10 hours
Population: Analyzing the date of application of pharmacological analgesia.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Experimental TENS | Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia | 7.0 cm | Standard Deviation 1.72 |
| Control Group | Evaluation of TENS During the Active Phase of Labor Over the Use of Analgesia | 6.41 cm | Standard Deviation 1.18 |
p-value: 0.25Wilcoxon (Mann-Whitney)
Secondary
Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor.
Simple questionnaire (Questionnaire satisfaction of parturients with comparision with experience in this study) developed for this study with 3 items (yes, no and do not want to answer) to assess satisfaction of mothers in the intervention group and the control group regarding the presence of a professional during the period of study and experience in this work.
Time frame: 10 hours
Population: All patients were invited to answer the questionnaire.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental TENS | Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor. | 17 participants |
| Control Group | Number of Participants Who Were Satisfied With the Presence of a Professional/Physiotherapist During Labor. | 7 participants |
Comparison: Fisher's exact testp-value: <0.01Fisher Exact