A Phase 4 interventional study of Lumbosacral Massage in Pain, sponsored by University of Sao Paulo. Completed at 1 site in Brazil. Open to female participants aged 15 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-03-05.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Treatment
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.
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%.
University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
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Exclusion Criteria:
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
Massage Group (GM):receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation
Other: Lumbosacral Massage
Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
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
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
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
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
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
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
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
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.
| Milestone | Control Group | Massage Group |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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.
| milimeters | Control Group | Massage Group |
|---|---|---|
| Before Procedure | 68.7 ± 16.5 | 69.0 ± 14.5 |
| After Procedure | 72.1 ± 15.4 | 51.7 ± 19.9 |
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.
| centimeters | Control Group | Massage Group |
|---|---|---|
| Pharmacological Analgesia Request According to the Cervical Dilation. | 6 ± 1.2 | 7 ± 1.3 |
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.
| participants | Control Group | Massage Group |
|---|---|---|
| Vaginal | 19 | 17 |
| Caesarian section | 4 | 6 |
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".
| percentage of participants | Control Group | Massage Group |
|---|---|---|
| Up to 7 hours | 83 | 57 |
| More than 7 hours | 17 | 43 |
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.
| centimeters | Control Group | Massage Group |
|---|---|---|
| Obstetric Outcome - Moment of Corioamniorrhexis | 8.0 ± 1.7 | 7.5 ± 1.7 |
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.
| centimeters | Control Group | Massage Group |
|---|---|---|
| Obstetric Outcomes - Moment of Utilization of Oxytocin | 6.0 ± 2.0 | 5.0 ± 2.8 |
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.
| participants | Control Group | Massage Group |
|---|---|---|
| Considered important presence of physiotherapist | 23 | 23 |
| Rated excellent the therapy received | 16 | 15 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | — | — | — |
| Massage Group | — | — | — |
| Age, Categorical(Participants) | Control Group | Massage Group | Total |
|---|---|---|---|
| <=18 years | 9 | 10 | 19 |
| Between 18 and 65 years | 14 | 13 | 27 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control Group | Massage Group | Total |
|---|---|---|---|
| Mean | 19 ± 3.7 | 19 ± 3.2 | 19 ± 3.5 |
| Sex: Female, Male(Participants) | Control Group | Massage Group | Total |
|---|---|---|---|
| Female | 23 | 23 | 46 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Group | Massage Group | Total |
|---|---|---|---|
| Brazil | 23 | 23 | 46 |
This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo