Non-pharmacological Resources in Assisting Labor

NCT ID: NCT01389128

Last Updated: 2019-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2012-07-31

Brief Summary

The proposed project will be conducted to evaluate the influence of application resources associated with non-pharmacological during labor for pain relief and accelerated phase of expansion. Although mothers' access to resources for non-pharmacological pain relief during labor is recommended, is not seen as the application of routine obstetric practice, although it has been demonstrated benefits and scientific evidence with your application. It is believed that the implementation of associated application of non-pharmacological resources in assisting the labor can be introduced into daily practice in various hospitals in the country, minimizing pain and favoring the shorter duration of labor, decrease in use of painkillers and inductors, resulting in a reduction of complications, improves the comfort of the mother making her birth experience more satisfying and rewarding, being assisted with security and trained by multidisciplinary teams.

Detailed Description

The current model of care delivery has demanded a technical-assistance approach that prioritizes the quality of care, as indissolubly concerns the employment of technology, knowledge, the centrality of dialogue between professionals and patients and individualized choice resources deemed suitable for safe delivery. Seeking to implement a less interventionist care with evidence-based practice and greater incentive to vaginal delivery, the programs were created humanization of labor and birth, with the use of various non-pharmacological resources. This study aimed to evaluate the effectiveness of the combination of non-pharmacological resources during the dilation in relieving the pain of the mothers. The research will be of type randomized controlled trial, consisting of low-risk primigravidae admitted at the Reference Center for Women's Health in Ribeirão Preto. The mothers will be distributed in two groups (intervention protocol features non-drug) and Control (routine maternity) and will be evaluated before and after application of each resource, and the control group in the same time according to cervical dilation. Evaluation will be conducted by a visual analog scale and / or facial pain and pain location diagram and postpartum will be applied a validated questionnaire Experience and Satisfaction with childbirth. 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%.

Conditions

Labour Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Routine care

Intervention Type: OTHER

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.

Intervention Group

Pregnant women who receive the application the combination of non-pharmacological resources according to cervical dilation: pelvic mobility , lumbosacral massage and warm shower.

Group Type: EXPERIMENTAL

Non-pharmacological resources

Intervention Type: OTHER

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:

• Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes;
• Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and,
• Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.

Interventions

Non-pharmacological resources

A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:

• Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes;
• Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and,
• Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Primigravida;
• Pregnancy only;
• Gestational age ≥ 37 weeks;
• Presentation fetal head
• Chorioamniotic intact membranes
• Working with spontaneous onset of labor
• Admission at the beginning of active phase dilation (4-5 cm)
• Lack of maternal and fetal pathologies
• Literacy - primary education
• Absence of cognitive problems

Exclusion Criteria

• Pregnant women admitted for induction of labor
• Rupture premature or early of chorioamniotic membranes
• Use of uterotonic drugs before the active phase

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Silvana Maria Quintana

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Silvana M Quintana, professor

Role: PRINCIPAL_INVESTIGATOR

Faculty of Medicine of São Paulo University

Locations

Referral Center Women's Health - Mater

Ribeirão Preto, São Paulo, Brazil

Countries

Brazil

References

Huntley AL, Coon JT, Ernst E. Complementary and alternative medicine for labor pain: a systematic review. Am J Obstet Gynecol. 2004 Jul;191(1):36-44. doi: 10.1016/j.ajog.2003.12.008.

Reference Type: BACKGROUND

PMID: 15295342 (View on PubMed)

Gallo RBS, Santana LS, Marcolin AC, Duarte G, Quintana SM. Sequential application of non-pharmacological interventions reduces the severity of labour pain, delays use of pharmacological analgesia, and improves some obstetric outcomes: a randomised trial. J Physiother. 2018 Jan;64(1):33-40. doi: 10.1016/j.jphys.2017.11.014. Epub 2017 Dec 27.

Reference Type: DERIVED

PMID: 29289579 (View on PubMed)

Other Identifiers

FR443033

Identifier Type: -

Identifier Source: org_study_id