Electing the Labor Analgesia and Satisfaction of Primiparous Women: An Interventional Study of the Impact of Shared Decision-Making

doi:10.21203/rs.3.rs-2475648/v1

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Electing the Labor Analgesia and Satisfaction of Primiparous Women: An Interventional Study of the Impact of Shared Decision-Making

https://doi.org/10.21203/rs.3.rs-2475648/v1

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Background: Most physicians and childbirth care providers choose analgesia for mothers during labor and childbirth based on their own preference for various reasons, which sometimes leads to the mothers’ dissatisfaction with the decision made in selecting the type of labor analgesia. Present study aimed to assess the impact of shared decision-making (SDM) in electing the labor analgesia on the satisfaction of primiparous women.

Methods: The present experimental study was conducted on primiparous women with a gestational age of 38- 42 weeks. The participants were assigned to the intervention (n=33) and control (n=33) groups using block randomization with block sizes of 4 and 6. Women in the intervention group decide about the type of pain relief based on SDM during the latent phase of labor after receiving the required information regarding various applicable analgesia methods. The questionnaires, including satisfaction with the decision, O'Conner’s decisional regret scale, and SDM questionnaires, were completed after childbirth. Data were analyzed by SPSS 24 software and independent t-test and ANCOVA were used.

Results: The baseline characteristic of participants was similar in both groups. After the intervention, the mean score of decision satisfaction‎ in the intervention group was significantly higher than that in the control group [Mean Difference (MD): 2.86, 95% CI: 1.94to 3.77, (P <0.001)]. The mean score of decisional regret (DR) in the intervention group was significantly lower than that in the control group [MD: -4.86, 95% CI: -5.95to -3.76, (P<0.001)]. After the intervention, the mean score of SDM in the intervention group was significantly higher than that in the control group [MD: 13.22, 95% CI: 10.33 to 16.12, (P<0.001)]. The highest mean difference in the intervention group was associated with the SDM and the lowest mean difference was associated with the decisional regret .

Conclusion: Participation of women in decision-making to choose the type of labor pain relief during childbirth improved decision satisfaction and perception of SDM. Therefore, it is recommended to use this method during labor and childbirth, since it is considered a patient's right and autonomy.

Shared Decision-Making

Labor Analgesia

Satisfaction

decision regret

The majority of pregnant women have little knowledge about the various methods of labor pain relief and their benefits and harms, and some women have incorrect information and expectations about these methods [1–3]. Although, women often experience severe pain, anxiety, and communication barriers during childbirth; however, the medical staffs refuse to state the risks of labor analgesia in most cases when they perform the analgesic process [4–8]. Therefore, interventions during labor and childbirth are often based on the physician's decision.

Also, the provision of services is physician-centered, especially for pregnant mothers during childbirth, and the physicians often consider their preferences for the patient which influence the patient’s satisfaction with the services provided [9–14].

Raising the patient's knowledge to make an informed decision is strictly and repeatedly emphasized in terms of professional ethics [15, 16]. Given the necessity of raising the awareness and knowledge of individuals to make an informed decision based on informed and Shared Decision-making (SDM) theories, it has always been emphasized that informed choice is something more than just the patient's signature on a legal document. Therefore, information should be completely exchanged between the patient and service provider to make a health-related decision, and the patient's values, beliefs and preferences should be considered in decision-making [9, 10, 12]. Further, the tendency of participants to use decision aid is one of the most important factors of the impact of the decision aid, which can have a significant effect on decision making [17]. In fact, SDM is regarded as an essential part of patient-centered care to provide high quality and evidence-based care [18].

Both the care provider and patient are involved in the SDM process to choose a treatment option, and the caregiver provides the patient with sufficient and comprehensive information and guidance to make the best decision tailored to her condition [19, 20]. The health care providers should discuss the risks and benefits of treatment options with patients to provide ultimately a shared clinical decision-making [21–26].

It is worth mentioning that midwives are regarded at the forefront of services providing for natural childbirth and can improve the quality of services and the consequences of pregnancy and childbirth by implementing a patient-centered SDM model. On the other hand, there is a study gap in the field of the impact of SDM on the informed choice of labor pain relief method by parturient women on the decision satisfaction. Further, SDM is not common in the culture of providing health services, especially in the area of obstetrics and gynecology in our country. Therefore, considering that raising awareness of patients to empower them in health-related decisions is considered a part of the patient's rights, the present study aimed to evaluate the effect of SDM in selecting the method of labor analgesia on the decision satisfaction ‎among primiparous women.

Study design and settings

The present study was an interventional study that conducted on 66 primiparous women with gestational age of 38 - 42 weeks hospitalized in Obstetrics and Gynecology Hospital in XXX for Natural delivery. The hospital was selected from two educational hospitals affiliated with Tabriz University of Medical Sciences. Tabriz University of Medical Sciences is the largest medical university in northwest Iran that has two large gynacological hospitals. Data collection was carried out from August to November 2020 (approximately 4 months). Satisfaction with the decision was the primary outcome. The secondary outcomes of the study included shared decision making and decisional regret. Criteria for the eligibility of women in the study were all primiparous pregnant women with gestational age of 38-42 weeks with a singleton pregnancy, absence of bleeding during third trimester, placental abruption, placenta previa, oligo and poly-hydramnios, fetal growth disorder, maternal chronic diseases, history of participating in childbirth preparation class, and indication for Cesarean Section (CS).

Sample size

The sample size was calculated based on the variable of decision satisfaction using G-Power software. According to the study by Causarano et al (Causarano et al., 2015) and considering m1= 68.4 (mean score of decision satisfaction‎ in the control group), m2 = 82.8 with a 20% increase due to the intervention, SD1= SD2=15, α = 0.05, and Power=95%, a sample size of 30 was determined per group. The final sample size was estimated at 33 for each group considering 10% attrition. Considering that the sample size calculated based on the variable of childbirth experience was higher, the final sample size of 33 was considered per group (Fig. 1).

Study participant’s selection procedure

The researcher attended the hospital delivery room and after introducing herself, invited all eligible women to participate in the study. Then, she provided them with a brief explanation of the study objectives and method, and women willing to participate in the study completed the written informed consent form. The pre-test questionnaire of demographic-obstetric characteristics was filled out in both control and intervention groups. The participants were assigned into the intervention and control groups with a ratio of 1:1 by blocked randomization using Random Allocation Software (RAS) with block sizes of 4 and 6. For allocation concealment, the type of allocation was written on a piece of paper and placed in opaque envelopes numbered consecutively according to the generated random allocation sequence. The envelopes were opened by a non-involved person in the sampling process in the order in which the participants entered the study.

Measurements.

All of questionnaires, including satisfaction with the decision (SWD), O'Conner’s decisional regret scale (DR), and SDM questionnaires, were completed in both group after childbirth.

Instruments

The demographic and obstetric questionnaire included the variables of age, marriage age, age of first pregnancy, age of first menstruation, educational level, occupational status, family income level, insurance status, and the number of pregnancies and deliveries.

The Satisfaction with Decision (SWD) questionnaire, developed based on the conceptual model of an effective decision of O’Connor and O BrienPallas (1989), was used to evaluate the satisfaction with health-related decisions. This simple and short questionnaire with 6-item is scored based on the 5-point Likert scale, ranging from strongly disagree (1) to strongly agree (5), as the high score represents more satisfaction. Cellia et al. reported a good internal consistency with the Cronbach’s alpha of 0.85 [27].

O'Conner’s Decisional Regret Scale (DR), initially developed by the University of Ottawa (1996), was employed to assess the decisional regret. This 5-item scale is rated on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree), and the items 2 and 4 are scored reversely. After calculating the mean score of the questionnaire, it is converted to 0-100 by subtracting one and multiplying by 25. A score of 0 displays that the patient has no decisional regret, and a score of 100 represents the most decisional regret. The Cronbach's alpha coefficient of 0.9 was reported for this instrument. The Cronbach’s alpha of 0.9 was reported for its internal consistency [28].

Intervention group

Parturient women who were assigned to receive the SDM for selecting the type of labor analgesia by childbirth care providers were implemented in the intervention group. The first and corresponding authors and also an anesthesiologist (the fifth author), who have experience of working in the delivery room, participated with the women in the intervention group in deciding on selecting the type of labor analgesia. Thus, complete information about the advantages and disadvantages of each of the pharmacological and non-pharmacological methods of labor analgesia, including nitric oxide gas, pethidine, epidural and remifentanil anesthesia, hot shower, massage, aromatherapy, and electrical nerve stimulation through the skin, was provided for women at the latent phase of labor (dilatation less than 6 cm) and before the onset of effective labor contractions. All the mentioned information’s also were demonstrated through a labor analgesia decision booklet. Finally, the women in the intervention group in consultation with the care providers selected one of the analgesic methods.

Control group

Pregnant women who received routine care during labor and childbirth, and the pain relief method was selected for them mainly based on the physician preference

Ethical approval

Ethical approval was obtained from the Ethics Committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.184). An informed and signed consent was obtained from each participant. Participants were informed that their participation in this study was voluntary, that the information they gave would remain confidential and used only for research purposes, and that they could also withdraw from participating in the study at any time.

Data analysis

The collected data were analyzed by SPSS/ 24 software. The normality of data was determined using the Kolmogorov-Smirnov test Demographic information was analyzed by independent t-tests for quantitative variables and by chi-square test for qualitative variables. Other outcomes including SWD, O'Conner’s DR), and SDM questionnaires were completed during the first 24 hours after childbirth and analyzed by using independent t-test.

During the recruitment period, from August to November 2020, a total of 115 mothers were visited the Tabriz Taleghani referral Hospital of Iran. A total of 49 women were excluded from the study. A total of 66 people were randomly assigned, of which 33 were in the intervention group and 33 in the control group. Figure 1 shows the flow of study participants’ selection (Fig1).

The mean (SD) age of participants was 23.88 (5.6). There was no significant difference between the two groups in the age of participants. More than 90% of women in both groups had diploma or less education. The occupation of most women in both groups was housekeepeer. The income level of half of the participants in both groups was relatively sufficient. Nearly three-quarters of women have planned and wanted pregnancy. Oxytocin use was reported in less than one quarter in the intervention and control groups during child birth (Table1). Allso women in the intervention group prefer less farmacological pain reliefs after intervention in comparison with control group (P <0.001) (Table 2).

Based on Independent T-test, after the intervention, the mean score of decision satisfaction‎ in the intervention group was significantly higher than that in the control group [Mean Difference (MD): 2.86, 95% CI: 1.94 to 3.77 (P<0.001)]. The mean score of DR in the intervention group was significantly lower than that in the control group [MD: -4.86, 95% CI: -5.65 to -3.76 (P<0.001)]. After the intervention, the mean score of SDM in the intervention group was significantly higher than that in the control group [MD: 13.22, 95% CI: 10.33 to 16.12, (P<0.001)] (Table3).

This study evaluated the impact of shared decision-making for electing the labor analgesia and satisfaction of primiparous women. Based on the findings, SDM in choosing the method of labor analgesia improved the SWD and SDM, and reduced DR scores. Consistent with the present study results , Raynes et al. (2009) reported that providing decision-aid booklets was effective in reducing DR and enhancing SWD in selecting the labor analgesia method [29]. In another study, Stacey et al. in their review study revealed that SDM on health-related issues including cancer screening and treatments reduces decisional conflict (DC) and DR and consequently, increases SWD [26], which is in line with the findings of the present study. Further, Montgomery et al. investigated the effect of decision aid ‎on SWD about choosing the type of delivery and demonstrated that decision satisfaction‎ significantly increased in the intervention group compared to the control group [30]. In addition, other studies examined the impact of decision-aid on pregnancy and childbirth-related issues, such as vaginal delivery after CS and pregnancy screening, and concluded that the use of decision-aid and SDM was effective in reducing DR and increasing decision satisfaction among women [31].

Consistent with the findings of the present study, the results of the review study of Poprzeczny et al. entitled “Decision aid tools, facilitating SDM in the field of obstetrics and gynecology” indicated the positive effect of SDM on facilitating decision-making regarding obstetrics and gynecology issues but their study not included the child birth pain relievers [32]. Similarly, based on the findings of another study, providing information to pregnant women about the methods of labor analgesia in line with SDM to choose the type of analgesia is very helpful [33].

The perception of parturient women and health caregivers about SDM for epidural analgesia was evaluated in a qualitative study by Godberg et al. (2014). Based on their results, some health caregivers, mainly specialist physicians, often tend to implement their own opinions and decisions for parturient women during labor and childbirth. Despite the pressures of physicians associated with decision-making for choice of epidural analgesia among childbearing women, nurses working in the delivery room try to involve women in decision-making by providing information and supporting them through SDM for epidural analgesia. Since women themselves tend to have shared and informed decision about labor pain relief.The results of their study demonstrated a difference in the views of physicians, other maternal health caregivers, and mothers during labor and emphasized the need to adopt programs focused on improving the relationship between childbirth caregivers and parturient women for SDM [34]. There are similar conditions in Iran and most specialist physicians make decisions for patients based on their own opinions and preferences. However, midwives often try to provide information to mothers and their families to participate them in decision-making for choosing the necessary measures and treatments and take a step toward SDM during labor and childbirth, since it is morally the right of patients.

Strength and limitations

Based on the authors search, the present study is the first research conducted in this field. Also, all the participants of present interventional study provided by appropriate individual session and counseling were performed by a researcher who has a university degree in counseling in midwifery who had received the necessary training for presenting shared decision making.

Due to the fact that women usually suffer from labor pains at active phase, to solve this problem decision aid was provided in the latent phase and the contents of the booklet and the information contained in it were fully explained to women. Most of the participants in the present study were Turkish speakers who sometimes had ambiguities in answering the questions of the present research tools which were in Persian. In order to solve this problem, all the tools were completed in the form of interviews and under the supervision of the researcher.

Implications for practice and research

Midwives and health care providers are the first ones to come into contact with parturient women. Therefore, informing and strengthening and counseling of this group can play an important role in promoting women's satisfaction of childbirth. Midwives can use this style of counseling (shared decision making) to increase the pleasant experience of childbirth, satisfaction with childbirth, minimum regret of the decision and improve childbirth services during childbirth. Whereas improving the quality of childbirth-related services by improving the level of satisfaction with mothers' experiences with childbirth is very important and necessary from the point of view of mothers; Health policymakers and planners are expected to identify cost-effective ways to enhance participatory decision-making methods also in obstetrics and gynecological areas.

Based on the results, SDM in choosing the method of labor analgesia reduces DR and improves SDM and decision satisfaction‎. The familiarity of health care providers with SDM can play an important role in changing health-related behaviors in the field of obstetrics and gynecology. The results of the present study can be utilized for further research and as a complement to previous research and as an infrastructure for future research. It is suggested to use the findings of the present study as a cost-effective method in middle- and low-income countries, to increase mothers' desire for natural childbirth and improve the maternal mortality rate by promoting the quality of care and satisfaction feeling among mothers.

Availability of Data and Materials

The datasets generated and/or analysed during the current study are not publicly available due [because the public sites are not accessible for us] but are available from the corresponding author on reasonable request.

Ethics approval and consent to participate

All methods were performed in accordance with the relevant guidelines regulations and the Declaration of Helsinki .The study was approved by the ethics committee at the Tabriz University of Medical sciences [Ethic code: IR.TBZMED.REC: 1399.184]. All participants signed a written informed consent form prior to their enrollment. Consent for publication not applicable.

Consent for publication

Not applicable.

Availability of data and material

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Competing interests

The authors declare that they have no competing interests.

Funding

This study was founded by the Research Deputy of Tabriz University of Medical sciences [grant Number: TBZMED.REC: 1399.184]. The study was undertaken as part of the project “Electing the Labor Analgesia and Satisfaction of Primiparous Women: An Interventional Study of the Impact of Shared Decision-Making”. None of the funding bodies participated in the design of the study; in the collection, analysis, and interpretation of the data; or in the writing of the manuscript.

Authors' contributions

Study concept and design: MSH, EM, RN. Acquisition, analysis and interpretation of data: EM Drafting of the manuscript: MSH, EM. Critical revision of the manuscript for important intellectual content: EM, RN, SHSHD. All authors have read and approved the manuscript.

Acknowledgements

The authors appreciate the faculty members of the Tabriz University of Medical Sciences (Tabriz, Iran) for their grateful assistance.

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Table 1. The socio-demographic and obstetrics characteristics of participants in the intervention and control groups

Table 2. The frequency distribution and the comparison of selected pain relief in the intervention and control groups.

Table 3. The comparison of mean score of decisional satisfaction, regret and SDM in the intervention and control groups after the intervention

No competing interests reported.

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Electing the Labor Analgesia and Satisfaction of Primiparous Women: An Interventional Study of the Impact of Shared Decision-Making

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