Efficacy of an educational manual for childbirth companions: pilot study of a randomized clinical trial

ABSTRACT Objective: to evaluate the effectiveness of an educational manual in the instrumentalization of companions to provide support to the parturients and check its influence on the satisfaction of companions and women during vaginal delivery. Method: pilot study of a randomized controlled clinical trial with 65 companions and puerperal women (intervention = 21 and control = 44). The previous knowledge of the companions was evaluated at baseline. The Evaluation Form for Companions in the Delivery Room was used to measure the actions provided and the satisfaction with the experience, and the Questionnaire for Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery was used to evaluate the satisfaction of women with childbirth. The Student’s t-test or Wilcoxon, chi-square or Fisher’s exact test, risk ratios and 95% confidence intervals were used. Results: the companions in the intervention group performed a greater number of support actions (7.2 vs 4.6, p: 0.001) and had higher satisfaction scores (72.4 vs 64.2; p = 0.00). Puerperal women in the intervention group had higher satisfaction with childbirth (119.6 vs 107.9; p: 0.000). Conclusion: the manual was effective for the instrumentalization of companions, contributed to support actions to the parturients and had repercussions on the satisfaction of companions and women with the birthing process. RBR-776d9s


Introduction
Childbirth is one of the most remarkable experiences in a woman's life. It involves a mixture of sensations, feelings, desires, overcomings, and challenges that make it a complex, multidimensional process involving physiological and cognitive aspects. In this sense it is important that companions be prepared and well trained to participate in this moment, supporting and comforting the parturients and bringing greater satisfaction to the process of delivery and birth. Stimulating the participation of companions in delivery and birth is part of the qualification of humanized childbirth care (1) .
Evidence shows that the continuous support from a companion who does not belong to the hospital's professional team during the delivery provides several benefits for the woman and the newborn (2)(3)(4) .
It is necessary, therefore, to develop and evaluate educational technologies for those who intend to participate in childbirth as companions, with the purpose of disseminating and expanding the knowledge about the physiology and care involved in the process of childbirth and techniques to support parturients. The lack of preparation of companions has been highlighted as one of the reasons for health institutions to prevent their presence (5) .
Based on the assumption that the development of educational technologies can contribute to the empowerment and better performance of companions in the delivery room, the manual entitled "Preparing to be a companion during vaginal birth: what is important to know?" (6) . This educational technology seeks to encourage the development of skills in those who intend to participate in childbirth as companions. It is also an important tool to dynamize the methodology used

This is a parallel, open, two-arm pilot Randomized
Clinical Trial (RCT). Pilot studies are conducted to guide decisions on how to outline recruitment, gauging and intervention approaches and are particularly useful in studies on new forms of intervention (7) . In this sense, The participants were recruited by the field team and randomized into the IG or CG using sequence of random numbers generated at www.randomizer.org.
The study was blinded to the field team responsible for evaluation phases III and IV, specified below. The

Data collection tools
Three instruments were used for data collection (two for companions and one for the women). The the Likert-type questions. This instrument was prepared based on a previous study (6) and evaluated by three researchers in the field of obstetrics.
The instrument 3 was a questionnaire entitled Evaluation of the Experience and Satisfaction of Puerperal Women with Labor and Delivery (9) . This questionnaire is The QESC has already been used and validated in a Brazilian study (10) and is divided into 8 subscales, of which the following were selected for the present study: Items with negative topics such as pain, fear, malaise and worry have a reverse score.
The QESC has a good internal consistency (Cronbach's alpha = 0.9087) and test-retest fidelity index of 0.586 (9) , allowing the consistent and reliable evaluation of the different dimensions that are relevant to the experience of childbirth.

Data colletion
Data collection was performed in four phases, with three different teams of collaborators: one team responsible for Phase I, another responsible for Phase II and one responsible for Phases III and IV. The   Rev. Latino-Am. Enfermagem 2017;25:e2996. Women whose companions were part of the IG had higher means in all the QESC subscales evaluated (Table 4).

Discussion
The results of this study show that the educational manual is an effective technology to instrumentalize companions to carry out support actions to parturient women, especially actions of physical support. This has a positive influence on the satisfaction of the companions and puerperal women with the experience of accompanying and experience the birth, respectively.
The companions that participated in the study have characteristics similar to those of other studies regarding age, years of schooling, sex, and degree of kinship with the women (11)(12)(13) . This shows that the sample studied represents well the Brazilian reality. providing counseling, education, trust and support (14) .
As shown in the flowchart of the study participants,  that may justify the greater dissatisfaction of the IG with the health professionals and with the way the labor process occurred.
Research that investigated the involvement of fathers during pregnancy and childbirth found that those who did not have qualification during prenatal care felt unprepared because they did not know how to help their wives, and impotent because they were mere spectators, they did not understand the work nor their role in this process (16) . In another study, fathers who had access to an educational intervention of preparation for childbirth had a lower risk of experiencing the childbirth event in a frightening way and feeling unprepared for birth (17) .
The educational manual, besides positively influencing the quality of the support provided by the companions in the delivery room, also contributed to the better evaluation of the women with respect to the experience of childbirth. A similar finding was obtained in a study that investigated the interference of the support provided by companions in the assessment of women regarding the experience of giving birth. The study found that the amount of support provided had a significant association with a positive evaluation of the women (18) . It is worth mentioning that the positive experience of the childbirth process also depends on factors such as availability and accessibility to health services, information and support networks, as well as the model of care provided by health professionals and the adoption of evidence-based practices (19) .
The present study allowed the delimitation of parameters for sample calculation in the definitive study, considering the mean difference in the outcome (number of support actions provided by companions). It was also possible to detect the need for adjustments in the data collection process, in order to minimize the interruption of the losses in the follow-up. It is recommended to ask the participants for a telephone contact of their close relatives in order to help when the attempts to contact the companion/postpartum woman are not successful.
It is also necessary to do home visits to the addresses provided in the identification section and/or by Community Health Agents, to interview the participants that could not be contacted by telephone. As a limitation of the study, it is worth mentioning the absence of psychometrically validated Brazilian instruments geared at the evaluation of the support provided by the companion. Another limitation is the disparity in the numbers of participants in the IG and CG.

Conclusion
The educational manual allowed the companion to provide a greater number and variety of actions to support the parturient. In addition, the use of the manual by the companions had a positive effect on the satisfaction of companions and women with the birthing process. In this sense, the manual is an effective educational technology to be used with this target audience.
We suggest the realization of further studies to evaluate the effectiveness of other educational interventions that potentiate the abilities of companions as providers of support to the women during the labor process and to evaluate the influence of this support on maternal and neonatal outcomes.