Menopausal women often face challenges in choosing appropriate interventions to mitigate distressing menopause symptoms, primarily due to concerns about treatment suitability. Therefore, the present study aimed to assess the effect of shared decision-making (SDM) on conflict and regret in menopause symptoms management.

This interventional study was conducted on 44 menopausal women aged ≥ 45 years in Tabriz, Iran, from September 2020 to January 2021. Subjects were randomly assigned to the intervention (n = 22), which received SDM-based counseling along with a decision aid (DA) booklet, and control (n = 22) groups. The data were collected using a socio-demographic and obstetric characteristics checklist, awareness of the menopause symptoms management strategies, decisional conflict, and regret. The intergroup differences were compared employing an independent t-test and ANCOVA.

The mean score of decision conflict [Mean difference (MD): -2.07, 95% CI: -29.65 to -11.92, P = 0.001] and decision regret [MD: -1.25, 95% CI: -1.64 to 0.64, P = 0.03] significantly reduced in the intervention group compared to the control group after the intervention. Additionally, a statistically significant increase in the mean score of women’s awareness was observed in the intervention group compared to the control group following the intervention [(Hormone Therapy: MD: 3.38, 95% CI: 1.01 to 5.57, P = 0.006) (Natural Products: MD: 2.44, 95% CI: 0.93 to 3.94, P = 0.002)].

The results indicated the effect of SDM-based counseling on improving women’s awareness of the menopause symptoms management strategies and reducing the decisional conflict and regret.

The majority of menopausal women experience some symptoms including vasomotor manifestations (hot flashes, night sweats), genitourinary complaints (vaginal dryness, urinary disorders), and psychological disturbances (restlessness, sexual dysfunction) [1,2,3]. To reduce the menopausal symptoms, approximately 50% of affected women pursue various therapeutic interventions, encompassing both pharmaceutical and non-pharmacological treatments [4,5,6]. Some of the common pharmacological treatments that are effective in improving vasomotor symptoms include clonidine, gabapentin, selective serotonin inhibitors, and venlafaxine [7]. Although Hormone Replacement Therapy (HRT) is one of the most effective pharmacological treatments for managing vasomotor symptoms, it is associated with complications and risks [8], which lead a high percentage of women to prefer non-pharmacological treatments such as complementary therapy, taking vitamins, and herbal remedies [9, 10].

A significant proportion of menopausal women utilize herbal medicines containing phytoestrogenic compounds including soy isoflavones, Trifolium pratense (red clover), and Actaea racemosa (black cohosh) for symptom management [11]. However, caution is warranted regarding phytoestrogen consumption, particularly among breast cancer patients and individuals with estrogen-sensitive malignancies, due to potential interactions with tamoxifen and other selective estrogen receptor modulators [12]. In addition, behavioral modifications, environmental adjustments, and lifestyle changes such as smoking cessation and alcohol reduction, cooling the air in the house, wearing thin and cotton clothes, rhythmic breathing, and changing sleeping and eating patterns are recommended to manage menopausal symptoms [1, 13].

The extensive available therapeutic options for menopausal symptom management, each with distinct risk-benefit profiles, creates a significant decisional complexity for patients [14]. However, despite the existence of numerous evidence-based pharmacological and non-pharmacological interventions, contemporary research reveals persistent gaps in women’s knowledge or sometimes incorrect knowledge regarding various treatment alternatives [15, 16]. Therefore, most menopausal women face decisional conflict when selecting therapeutic approaches to reduce the bothersome menopausal symptoms, frequently leading to post- decisional regret and dissatisfaction with their chosen management strategies.

The use of shared decision-making (SDM) and decision aid (DA) is suggested to address challenges in health-related decision-making processes [17]. The SDM-based interventions aim to help individuals to discuss on health-related decisions and understand the facts about choices, benefits, and harms precisely and clarify the values associated with the choice [18, 19]. Existing research in obstetrics and gynecology demonstrates the efficacy of SDM in promoting patient-centered care and enhancing decision quality and evidence based qualitative care [20,21,22,23,24,25]. Despite the studies conducted in this field, significant gaps remain regarding the information about the implementation and outcomes of SDM interventions in middle-income countries.

SDM complemented by DA booklet represents a distinct paradigm from conventional health-related education. This approach precisely points to each therapeutic option with its associated outcomes, enabling value-sensitive choices. However, routine health education only helps people better understand the diagnosis and treatment of the disease, without incorporating the essential elements of collaborative decision-making [14, 26], and lacks case-specific recommendations, personalized counseling frameworks, and tailored DA tools for facilitating informed and patient-centered decisions [27].

Considering the global rise in female life expectancy [28], identifying an appropriate method to alleviate the menopausal symptoms has become increasingly crucial. Despite the positive benefits of the SDM method for healthcare outcomes, its adoption remains limited, especially in Iran. Regarding the importance of women’s health during menopause and the lack of studies in this field, the present study aimed to investigate the the effect of SDM on decisional conflict and regret in the management of menopausal symptoms.

This study was conducted on 44 postmenopausal women referred to the health centers in Tabriz, Iran between September 2020 and January 2021. The inclusion criteria were women aged 45 years and 1–5 years passed since their last menstruation, experiencing at least one symptom of menopause, speaking and listening ability (Persian language), having basic literacy of reading and writing, having contact number for follow-up, and previous unsuccessful attempts to alleviate menopausal symptoms. The exclusion criteria were participating in similar interventional or educational programs for menopausal symptoms management, using any effective physician-prescribed medication for menopausal symptoms such as hot flashes, cancer, mental health disorders based on self-expression, Primary Ovarian Insufficiency (POI), and any mobility restriction disease.

The sample size was calculated based on the variables of decisional conflict and regret, as well as awareness using G-Power software (latest ver. 3.1.9.7; Heinrich-Heine-Universität Düsseldorf, Düsseldorf, Germany). Based on the findings of O’Connor et al. on the decisional regret variable [29] and considering M₁ = 16.50 (mean score in the control group), M₂ = 19.8 (assuming a 20% decrease due to intervention), SD₁ = SD2 = 3.6, two-sided α = 0.05, and Power = 80%, the sample size was computed to be 20 per group. Given that the sample size calculated based on the decisional regret variable was larger than that calculated for other variables and considering 10% attrition, the final sample size was estimated 22 per each group.

Present study was performed on postmenopausal women referring to the health centers in Tabriz, Iran. The sampling was done after obtaining permission from the Ethics Committee of Tabriz University of Medical Sciences (IR.TBZMED.REC.1399.244) and receiving an introduction letter from the Research Deputy of the Faculty of Nursing and Midwifery in Tabriz.

The city of Tabriz has 92 comprehensive health centers. Participants were recruited from the most frequented health centers located in various areas with different socio-economic classes. The author visited the selected centers and obtained data on menopausal women using the integrated health system (IHS), known as the “SIB System”. Then, she called eligible women, provided them with a brief explanation of the research objectives, and asked them to participate in the study. The participants were assigned into the intervention (SDM-based counseling) and control groups based on the number of pregnancies (first or second pregnancy) with a ratio of 1:1 and block sizes of 4 and 6 using a stratified block randomization method. A co-author, other than the data analyzer and the one who selected the participants, assigned them to the groups. To conceal the allocation sequence, the intervention type was written on a piece of paper and placed in opaque envelopes, numbered consecutively. This study employed a single-blind design, due to the interactive nature of the consultation-based intervention.

The objectives and methods of the study were explained to the eligible women in the first introductory session and a written informed consent form was obtained from participants to participate in the study. Pre-test questionnaires including socio-demographic and obstetric profile, knowledge and awareness regarding the menopausal symptoms management methods were completed by interview. An individual SDM-based counseling session was held in the intervention group for 90–60 min with the provision of a DA booklet to obtain more information about menopause and its symptoms and treatments, as well as the benefits and harms of each therapeutic solution. During the counseling session, efforts were made to establish effective communication between the participant and the counselor. As an active listener, the counselor responded to their concerns and questions with interest. Through open-ended questions, participants were encouraged to discuss menopausal symptoms negatively influencing their daily functioning, as well as any pharmaceutical or herbal remedies they were familiar with. To enhance participants’ engagement and understanding, visual aids including PowerPoint slides and illustrative images were incorporated during part of the consultation session, which facilitated better concentration and comprehension of the counseling content. Counseling was provided by the first author (a certified midwife holding master’s degree in midwifery with over ten years of midwifery experience, who participated in SDM workshops and obtained a certificate). Counseling was done in the counseling room located at the nearest health center to each participant’s home. A follow-up, individualized counseling session was offered to all participants to reassess their available options and the choices they had made. Furthermore, an additional session was scheduled upon participants’ request if needed. During the follow-up period, the researcher (the first author) provided her contact number to the participants and sent them DA-related SMS messages and answered their questions.

The content of counseling session is as follows:

The counseling sessions adhered to the key stages of SDM including eliciting patient participation, guiding subjects to explore and compare options, assessing individual values, preferences, and contextual factors, facilitating decision-making, and evaluating the chosen decision. The counseling content encompassed explaining and introducing SDM, physiological menopausal symptoms, and evidence-based symptom management methods including pharmacological (hormonal therapy), herbal remedies (black cohosh, flaxseed, soybean, maca, St. John’s wort, primrose oil, dong quai, red clover, ginseng, valerian, five finger plant), cognitive behavioral methods and lifestyle modifications. Each treatment modality was presented with its associated benefits and risks (Tables 1, 2 and 3).

The evidence-based DA booklet comprehensively detailed all afirementioned treatment options. To ensure content validity, materials were derived from authoritative sources including clinical guidelines, peer-reviewed publications (reference books, systematic reviews, and randomized controlled trials and and expert consensus recommendations. A multidisciplinary review panel comprising including five obstetricians, two gynecologists, two complementary medicine specialists, and three postmenopausal women were asked to evaluate the content for clinical accuracy. Then, the comments were applied to complete and modify the content.

At the conclusion of the session, the DA booklet was provided to the participants for free to read it.

Finally, 4-week after the intervention, awareness, decisional conflict and regret questionnaires were completed by participants in two groups by interview.

The data were collected using the questionnaires of socio-demographic and obstetric characteristics, O’Conner’s Decisional Conflict (DC), Decisional Regret Scale, and a researcher-made questionnaire of knowledge and awareness on the menopausal symptoms management method.

The socio-demographic and obstetric characteristics questionnaire included the items of age, education, occupation, age of first menstruation, age of menopause, etc.

O’Conner’s Decisional Conflict scale [29] with 16 items was employed to evaluate subjects’ uncertainty in making health-related decisions. The scale consists of five subscales including being informed (3-item), clarity of personal values (3-item), decision-making uncertainty (3-item ), perceived support (3-item ), and decision effectiveness (4-item). The items are scored on a 5-point Likert scale ranging from 1 (strongly agree) to 5 (strongly disagree). The total score of the items was calculated by summing up all the items, divided by 16, and multiplied by 25 and the total score ranged between 0 and 100. Lower scores in the subscales and the overall score indicate less decisional conflict, whereas higher scores represent higher decisional conflict. The reliability of the Decisional Conflict Scale was originally established by O’Connor, Annette M. (1995), through assessment of internal consistency using Cronbach’s alpha, which was reported as 0.81. Furthermore, the Internal Consistency Coefficient (ICC) for the scale was reported between 0.78 and 0.92, indicating acceptable reliability [30]. The validity of the instrument was confirmed by Baharvand et al. in Iran, supporting its applicability within the local population [31].

The Decisional Regret Scale (DRS), developed by O’Connor et al. (1996) at the University of Ottawa (1996), assesses regret following health-related decisions [32]. This 5-item instrument employs a 5-point Likert scale (0 = strongly agree, 4 = strongly disagree), with items 2 and 4 reverse-scored. The mean score of the scale was obtained in a range between 0 and 100 by subtracting 1 and multiplying by 25. A score of zero demonstrates no decisional regret and a score of 100 displays the maximum decisional regret. The internal consistency of the scale was confirmed by Brehaut et al. (2003), with Cronbach’s alpha reported between 0.81 and 0.92 [33]. Additionally, Moudi et al. validated the Persian version of the instrument for use among Iranian populations [34].

A researcher-made questionnaire on the menopausal women’s awareness regarding menopausal symptoms management was employed. This scale includes 14 items, divided into two sections. The first section includes nine items focused on the knowledge of hormone therapy, each rated on a 5-point Likert scale (0 = strongly agree, 4 = strongly disagree), with the total score range of 0–45. The second section comprises five items assessing awareness of natural, herbal, and non-pharmacological methods, rated on a 5-point Likert scale (), with scores ranging from 0 to 20 (completely disagree) to 4 (completely agree) [4] and the total score range is between 0 and 20. The content validity was evaluated qualitatively by soliciting expert feedback. The scale was reviewed by a panel of 10 respected faculty members of Tabriz University of Medical Sciences. Based on their input, necessary revisions were made, and the reliability of the final version was confirmed through internal consistency analysis, yielding a Cronbach’s alpha coefficient of 0.89.

As illustrated in Fig. 1, following an assessment based on the inclusion criteria, 44 out of 85 menopausal women aged ≥ 45, 44 women met the inclusion criteria and were randomly assigned into the intervention (n = 22) and control (n = 22) groups.

The SPSS₂₆ software was employed for data analysis. First, the normality of the quantitative data was checked using the Kolmogorov-Smirnov test, and all the data had a normal distribution. Before the intervention, an independent t-test was used to compare the mean score of awareness and decisional conflict and regret between the groups, and after the intervention, ANCOVA was applied by adjusting the effect of baseline score and p < 0.05 was considered significant.

Flowchart of the study

Full size image

No statistically significant difference was found in the socio-demographic and obstetric characteristics of the participants in the intervention and control groups (p < 0.05) (Table 4). The mean age of women was 51.82 and 51.68 years in the intervention and control groups, respectively.

Following the intervention, the mean (SD) total score of decisional conflict in the intervention group was lower than that in the control group [MD: − 32.74, 95% CI: -23.95 to -41.52, P = 0.001]. Furthermore, after adjusting for baseline values, all subscales of decisional conflict including being informed, clarity of values, decision effectiveness, perceived support, and uncertainty showed significantly lower mean scores in the intervention group compared to the control group [MD: -30.68, 95% CI: -20.41 to -40.95, P < 0.001], [MD: -33.31, 95% CI: -22.25 to -44.37, P < 0.001], [MD: -27.12 95% CI: -15.48 to -38.77, P < 0.001] [MD: -41.65, 95% CI: -31.04 to -52.26, P < 0.001], and [MD: -35.81, 95% CI: -25.21 to -46.41, P < 0.001], respectively. After the intervention, the comparison of the mean score of decisional regret in choosing the menopausal symptoms management method demonstrated a statistically significant reduction in the intervention group compared to the control group [MD: -1.25, 95%CI: 0.64 to -1.64, P = 0.03] (Table 5).

Following the intervention, there was a statistically significant increase in the mean score of women’s awareness of hormonal therapy methods for menopausal symptoms in the intervention group compared to the control group [MD: 3.38, 95% CI: 5.75 to 1.01, P = 0.003]. In addition, a statistically significant increase was observed in the mean score of women’s awareness of natural, herbal, and non-pharmacological treatment methods for menopausal symptoms in the intervention group compared to the control group following the intervention [MD: 2.44, 95% CI: 3.94 to 0.93, P = 0.002] (Table 6).

Due to the nature of the intervention (educational) in present study, no harms was observed for the participants in the present study.

Based on the findings, the implementation of SDM-based counseling in combination with the distribution of a DA booklet significantly enhanced women’s awareness of both pharmacological (hormonal) and non-pharmacological strategies for managing menopausal symptoms. Moreover, this approach effectively reduced decisional conflict and regret related to the choice of symptom management methods.

The results of the present study indicated that the combined use of a DA and an educational booklet significantly reduced decisional conflict regarding the selection of menopausal symptom management strategies. Legare et al. (2008) investigated the effect of DA on the use of herbal remedies in Canada to resolve the menopausal symptoms and compared the effectiveness of providing a DA booklet and educational brochure on decisional conflict. They reported no significant difference in the decisional conflict scores between the two groups, despite a modest reduction observed in the DA group [19]. It seems that the ineffectiveness of the intervention in the aforementioned study was due to the lack of SDM-based intervention along with providing booklets to the participants, while the present study provided SDM along with a DA booklet in the intervention group.

In another study, O’Conner et al. evaluated the effect of DA on decisional conflict for choosing hormone therapy during the menopause and indicated the effect of DA on reducing decisional conflict [35, 36], which is consistent with the results of the present study. It is worth mentioning that the aforementioned studies failed to examine the counseling along with the DA booklet and only reported the positive effect of reading the DA booklet on reducing decisional conflict. It seems that the effectiveness of the DA booklet al.one and without providing counseling can be attributed to the strong study culture of autonomous decision-making and health literacy in developed countries.

In the present study, DA-based counseling effectively reduced decisional regret among menopausal women. The women in the intervention group reported lower levels of regret and greater satisfied with their chosen method for menopausal symptoms management compared to the control group, following counseling and receiving the DA booklet. Consistent with the findings of the present study, Nananda et al. (2007) assessed the effectiveness of DA combined with general education on Canadian patients and reported a significant reduction in decisional regret in the intervention group compared to the control group [15]. In addition, SDM-based interventions increased decisional satisfaction and reduced decisional regret [37]. In the same vein, a reduction in decisional regret was observed after SDM-based interventions in a study by Rothert et al., which is in line with the findings of the present study [38].

In the present study, SDM-based counseling effectively enhanced the awareness of menopausal women regarding pharmacological and non-pharmacological treatment methods for managing menopausal symptoms. The women’s awareness significantly increased in the intervention group compared to the control group after the intervention. These results are congruent with the findings of Menard et al. (2010) examined the effect of DA on the use of herbal remedies to relieve menopausal symptoms. They reported that the DA tool and educational booklet regarding the use of herbal remedies during menopause improve the knowledge and awareness of menopausal women [39].

Furthermore, Shapira et al. (2007) investigated the effect of DA on the hormone therapy selection decision during the menopause period in America and the findings illustrated a significant difference in the knowledge and awareness between the intervention and control groups [40]. In another study, Saver et al. (2007) evaluated the impact of decisional support during the menopause in America and indicated that decisional support improved the menopausal women’s awareness and facilitated informed decision-making regarding hormone therapy [41]. Congruent with the findings of this study, Dayaratna et al. (2021) reported that the SDM-based intervention increased women’s treatment knowledge, reduced decisional conflict about treatment, and improved clarify in treatment preference [42].

In contrast to similar studies conducted in other countries, participants in the present study had previously attempted at least one treatment solutions to alleviate menopausal symptoms before participating in this study. However, they expressed dissatisfaction with their previous decision and were actively seeking alternative solutions, This context provided a unique opportunity to assess the effectiveness of the SDM approach among women firsthand experience with various, yet insufficient, treatment strategies. The findings of this study indicated the SDM-based counseling intervention significantly enhanced participants’ awareness and reduced decisional conflict, even among those who had previously struggled to make satisfactory treatment decisions. These results highlight the potential of SDM to support more informed, personalized, and ultimately more satisfying healthcare choices among menopausal women.

One of the strengths of this study is the use of random allocation and allocation concealment to minimize selection bias. This study employed standardized and psychometrically validated instruments, as their reliability and validity had already been assessed in the Iranian context. Additional strengths include the integration of SDM-based counseling with an evidence-based and validated decision aid (DA) booklet, as well as the use of face-to-face interactions and interviewer-administered questionnaires, which likely enhanced the accuracy and completeness of the collected data. This study was the first comprehensive research about pharmacological and non-pharmacological menopausal symptom management methods. the low-cost, accessible, and easily implementable nature of the intervention within the research setting, which enhances the feasibility of its application in similar healthcare environments. However, a limitation of the study was the inability to blind participants and outcome assessors due to the nature of the intervention, which may have introduced a risk of performance or detection bias. Despite this constraint, the use of validated tools and structured data collection procedures helped to mitigate potential biases and strengthen the reliability of the findings.

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LMGh contributed to the concept and design, data collection, conducting consultation sessions and drafting the manuscript. EM contributed to the conception and design, data collection, blinded data analysis, data interpretation, and writing of this manuscript. MAJ, SH, and RN in collaboration with coauthor (MAB), contributed to the conception and design of the interpretation and revision of this manuscript. All authors gave their final approval for publication of this manuscript.

Correspondence to Esmat Mehrabi.

This study was approved by the Deputy of Research and Technology of Tabriz University of Medical Sciences (ethical code: IR.TBZMED.REC.1399.244). Written informed consent was obtained from all individual participants who participated in the study. In addition, all methods are done in accordance with relevant guidelines and regulations.

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The authors declare no competing interests.

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