Pain
Conditions
Keywords
labor, pain, massage
Brief summary
The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed 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, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire.
Detailed description
The pain in labor appears as a subjective experience, individual interaction involving a broad physiological, psychosocial and environmental influences, representing one of the main clinical signs of this phase. Despite presenting an important biological function, is today well established the need for their relief, since its persistence is associated with harmful effects on mother and fetus. Among the available non-pharmacological resources, we highlight the massage therapy that has shown positive effects in relieving pain and promoting the comfort of the mother. The objective of this research is to evaluate the effect of massage therapy as a resource for pain relief during the active phase of labor. The research will be of type randomized controlled trial, consisting of low-risk nulliparous pregnant women admitted to the Referral Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (lumbosacral massage) and control (routine maternity) and will be assessed 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, Diagram Location of Pain and Pain Questionnaire McGll (reduced form). After delivery will apply a customer satisfaction questionnaire. 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
OTHERLumbosacral Massage
Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
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
* Nulliparous * literate * A single fetus in vertex position * Low-risk Pregnancy * From 37 weeks of gestation * Cervical dilatation from 4 cm with normal uterine dynamics in this phase * Labor in early spontaneous * No use of medications during the study period * Absence of cognitive or psychiatric problems * Intact membranes * No risk factors associated * You want to participate and signing the informed consent
Exclusion criteria
* Use of drugs or any procedure that aims to relieve pain * Intolerance to the application of massage therapy * Presence of dermatological conditions that indicate against the application of massage therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effectiveness of Massage Therapy in Pain Relief During Labor. | 30 minutes | The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstetric Outcomes - Delivery | 10 hours | Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress. |
| Obstetric Outcomes - Duration of Labour | 10 hours | The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours. |
| Pharmacological Analgesia Request According to the Cervical Dilation. | 10 hours | In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods. |
| Obstetric Outcomes - Moment of Utilization of Oxytocin | 10 hours | Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor. |
| Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. | 30 minutes | Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject. |
| Obstetric Outcome - Moment of Corioamniorrhexis | 10 hours | Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor. |
Countries
Brazil
Participant flow
Recruitment details
This was a randomized and controlled non-inferiority clinical trial with a blind rater involving comparative analysis of a study group and a control group. The study included 46 parturients admitted to the Reference Center of Women's Health of Ribeirão Preto-MATER, state of São Paulo, Brazil, during the period from September 2009 to May 2010.
Pre-assignment details
149 women in labour were eligible, were excluded because their women 103 not attended the criteria for inclusion (primigesta, single fetus cephalic position, low-risk pregnancy, least 37 weeks, cervical dilation 4-5 cm, spontaneous onset of labor, no use of medication during the study period, intact membranes, and no associated with risk factors).
Participants by arm
| Arm | Count |
|---|---|
| Control Group Control Group (CG) that will receive the routine procedures of motherhood, but will be monitored and evaluated at the same time in the intervention group | 23 |
| Massage Group Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation | 23 |
| Total | 46 |
Baseline characteristics
| Characteristic | Massage Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 9 Participants | 19 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants | 14 Participants | 27 Participants |
| Age, Continuous | 19 years STANDARD_DEVIATION 3.2 | 19 years STANDARD_DEVIATION 3.7 | 19 years STANDARD_DEVIATION 3.5 |
| 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 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Effectiveness of Massage Therapy in Pain Relief During Labor.
The Visual Analogue Scale was used to assess the pain intensitiy after each procedure according to the study design. The VAS is a scale composed by a straight line printed on a paper measuring 100 milimeters, where only the 0 (Zero) and the 100 (one hundred) points are marked. The patient is then asked to mark this line accordingly to the intensity of the pain felt in that moment, considering 0 (Zero) to be no pain at all, and 100 (one hundred) to be the most unbearable pain ever suffered. The researcher would measure the distance, in milimeters, from the 0 (Zero)mm to the point were the patient marked, wich was considered to be the intensity of the pain felt by the patient in that moment. A reduction of 13mm or more in this scale is considered to be a significative pain reduction.
Time frame: 30 minutes
Population: A pilot study was conducted previously to determine the size of the population needed. Using a paired sample t-test, with a power of 95% and 5% significance level, it was determined a minimum of 12 patients for Control Group and 16 patients for Massage Group
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control Group | Effectiveness of Massage Therapy in Pain Relief During Labor. | Before Procedure | 68.7 milimeters | Standard Deviation 16.5 |
| Control Group | Effectiveness of Massage Therapy in Pain Relief During Labor. | After Procedure | 72.1 milimeters | Standard Deviation 15.4 |
| Massage Group | Effectiveness of Massage Therapy in Pain Relief During Labor. | Before Procedure | 69.0 milimeters | Standard Deviation 14.5 |
| Massage Group | Effectiveness of Massage Therapy in Pain Relief During Labor. | After Procedure | 51.7 milimeters | Standard Deviation 19.9 |
Secondary
Obstetric Outcome - Moment of Corioamniorrhexis
Corioamniorrhexis may occur during the normal evolution of labour or due to medical conditions. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable datum rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.
Time frame: 10 hours
Population: All patients in both groups were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Obstetric Outcome - Moment of Corioamniorrhexis | 8.0 centimeters | Standard Deviation 1.7 |
| Massage Group | Obstetric Outcome - Moment of Corioamniorrhexis | 7.5 centimeters | Standard Deviation 1.7 |
Secondary
Obstetric Outcomes - Delivery
Labour can either occur via vaginal canal, also called natural birth, or via caesarian section, which is a surgical procedure used when either the mother or the baby are in distress.
Time frame: 10 hours
Population: All patients of both groups were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Obstetric Outcomes - Delivery | Caesarian section | 4 participants |
| Control Group | Obstetric Outcomes - Delivery | Vaginal | 19 participants |
| Massage Group | Obstetric Outcomes - Delivery | Vaginal | 17 participants |
| Massage Group | Obstetric Outcomes - Delivery | Caesarian section | 6 participants |
Secondary
Obstetric Outcomes - Duration of Labour
The time elapsed between hospital admission and delivery was measured to compare the influence of the procedures established in the study design. It was defined two sets of measures dichotomizing the groups into up to 7 hours or more than 7 hours.
Time frame: 10 hours
Population: All patients in both groups were analyzed
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Obstetric Outcomes - Duration of Labour | Up to 7 hours | 83 percentage of participants |
| Control Group | Obstetric Outcomes - Duration of Labour | More than 7 hours | 17 percentage of participants |
| Massage Group | Obstetric Outcomes - Duration of Labour | Up to 7 hours | 57 percentage of participants |
| Massage Group | Obstetric Outcomes - Duration of Labour | More than 7 hours | 43 percentage of participants |
Secondary
Obstetric Outcomes - Moment of Utilization of Oxytocin
Oxytocin is a drug used to induce or enhance the muscular activity of the uterus. In this study, the moment when this event happened was associated to the dilation of the uterus cervyx, considering this to be a more reliable data rather than the timelapse of labor. This outcome is measured in centimeter when the women is assessed by the doctor.
Time frame: 10 hours
Population: All patients in both groups were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Obstetric Outcomes - Moment of Utilization of Oxytocin | 6.0 centimeters | Standard Deviation 2 |
| Massage Group | Obstetric Outcomes - Moment of Utilization of Oxytocin | 5.0 centimeters | Standard Deviation 2.8 |
Secondary
Pharmacological Analgesia Request According to the Cervical Dilation.
In the institution where this study was conducted, the request for analgesia, made by the patient, is granted promptly. Considering that the further the cervyx dilation grows, the greater the pain intensity is, the cervical dilation was used as an indicator of the moment that the women in labour requested this procedure, and, therefore, could provide a comparison between methods.
Time frame: 10 hours
Population: Of the 46 patients who where evaluated, only 1 (one) in each group didn't request pharmacological analgesia and, thus, were excluded of the analysis of this specific outcome
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Pharmacological Analgesia Request According to the Cervical Dilation. | 6 centimeters | Standard Deviation 1.2 |
| Massage Group | Pharmacological Analgesia Request According to the Cervical Dilation. | 7 centimeters | Standard Deviation 1.3 |
Secondary
Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period.
Considering the first labour to be a unique experience to every women, and also a moment of many doubts and insecurities, it is considered that the presence of a healthcare professional, providing information and support, during this moment, could be benefitial to most first time mothers. Therefore, the presence of a physiotherapist could have helped minimize the suffering in both groups. The questionnaire applied after labour intended to assess how most women felt regarding this subject.
Time frame: 30 minutes
Population: All patients participatin in the study answered a satisfaction questionnaire after labour.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control Group | Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. | Rated excellent the therapy received | 16 participants |
| Control Group | Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. | Considered important presence of physiotherapist | 23 participants |
| Massage Group | Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. | Rated excellent the therapy received | 15 participants |
| Massage Group | Satisfaction of Mothers With the Presence of a Professional by Their Side During the Study Period. | Considered important presence of physiotherapist | 23 participants |