To design and validate a health promotion program for women with endometriosis.

What are the dimensions of a health promotion program in women with endometriosis?

Determining a health-promoting lifestyle and its relationship with the effects of the disease in women with endometriosis.

Exploring the perception and experience of women with endometriosis from a health-promoting lifestyle.

Designing and validating the health promotion program for women with endometriosis.

The sample size was determined based on both specific objectives related to a health-promoting lifestyle and the impact of endometriosis. Based on the results of Abd-Elaziz Ibrahim et al.'s study (6) and taking into account the largest standard deviation (SD = 3.74) observed in the health-promoting lifestyle subdomains, typically in the spiritual growth subdomain, with α = 0.05, power = 90%, and d = 0.05, a sample size of 186 women calculated around a mean of 15.32 was obtained. Moreover, based on the results of Moradi et al.'s study (20) and taking into consideration the largest standard deviation of disease impacts subdomains (SD = 32.7) for the fertility subdomain, with α = 0.05, power = 90%, and d = 0.05, a sample size of 196 women calculated around a mean of 65.28 was obtained. Given that the sample size determined based on the variable of disease impact was larger, the final sample size was calculated to be 196 women, rounded to 200.

The present study was confirmed by the Ethics Council of Mashhad University of Medical Sciences (ethics code: IR.MUMS.NURSE.REC.1401.064). Subsequently, data collection will commence at the endometriosis clinic of Imam Reza Hospital in Mashhad. The researchers will attend the endometriosis clinic, and eligible women will be identified by referring to their medical records and invited to participate in the study using convenience sampling based on the inclusion and exclusion criteria. Before the study, written informed consent will be obtained from the participants. The researchers will introduce themselves to the patients and provide them with necessary explanations regarding the study's purposes. Then, the patients will be given written questionnaires to complete.

Data will be collected using the Health-Promoting Lifestyle Profile II (HPLP-II) (21) and Endometriosis Impact Questionnaire (EIQ) (20). In addition, the researchers will develop sociodemographic and obstetric questionnaires, including inquiries on age, education, occupation, income sufficiency for expenses, first-degree relatives, obstetric and reproductive information, and history of smoking/hookah use, alcohol consumption, chronic diseases, autoimmune diseases, and allergies.

Study participants will be women with a confirmed endometriosis diagnosis and treatment records from an endometriosis clinic (women aged 15–49 years diagnosed with endometriosis by open surgery, laparoscopy, histological examination, presence of endometrioma cyst, or diagnosis via ultrasound and MRI confirmed by a gynecologist). Moreover, women will be involved in the study if they met the following: diagnosed with endometriosis localized to the pelvis and peritoneum, experienced the onset of endometriosis symptoms at least 1 year, diagnosed with no presence of endometriosis in the partial region or remote organs, (e.g., lungs and brain), had Iranian nationality, married, literate to answer questions, non-menopausal status (amenorrhea for over a year), and did not suffer from any other major diseases, such as mental disorders, severe depression, schizophrenia, or chronic diseases, such as diabetes, kidney disease, rheumatological disorders, cancer, and life-threatening diseases.

Contrary to the results of some studies suggesting no relationship between the severity or stage of endometriosis and the severity of the symptoms (22–25), we will not consider the stage of the disease as an inclusion criterion in this study.

The women who decline to further cooperate and submit an incomplete questionnaire (with >10% of the questions left unanswered) will be excluded from our study.

The HPLP-II questionnaire, as a standard questionnaire for examining health-promoting lifestyles, includes 52 questions in six dimensions: nutrition, physical activity, spiritual growth, health responsibility, stress management, and interpersonal relationships. All items are scored on a Likert scale ranging from 1 to 4 (1 = never, 2 = sometimes, 3 = often, 4 = always) (26). This questionnaire has been used in numerous previous studies (6, 17, 27). The English version of the HPLP-II questionnaire was translated into Persian, and its validity and reliability were assessed in earlier studies in Iran (24, 28). The Cronbach's alpha for the questionnaire was reported as 0.87 in a study on the elderly population aged 65 years or older ((29).

Another instrument used in this study is EIQ, which was originally developed and psychometrically analyzed by Moradi et al. (20). EIQ was initially designed in Australia and applied for the first time in Iran. This questionnaire aims to measure the long-term impacts of chronic endometriosis on various aspects of women's lives with endometriosis. Comprising 63 items, it assesses the impact of the disease on multiple dimensions of the affected women's lives, including the impact of the disease on physical, psychological, social, marital intimacy and sexual relationships, fertility, occupational and financial aspects, education, and lifestyle across three distinct periods (the last 12 months, 1–5 years ago, and >5 years ago). The English version of the EIQ questionnaire was translated into Persian, and its validity and reliability were assessed in earlier studies in Iran. CVI and CVR values of the EIQ tool were 0.97 and 0.94, respectively. The item-to-total correlation confirmed the construct validity of all seven dimensions of the tool, more than the cutoff (0.3), except for lifestyle. Cronbach's alpha coefficient and intracorrelation coefficient (ICC) were acceptable for all dimensions (9).

While other instruments, such as the EHP-30, assess quality of life over shorter periods (e.g., the past 4 weeks), the EIQ uniquely captures the chronic and recurrent nature of endometriosis by focusing on long-term effects. Similar to the ETSQ and EPBD, the EIQ was developed using patient input from focus groups and interviews, mirroring the process used for the ECQ, albeit with different developmental methods. Furthermore, the EIQ includes unique subscales for education and lifestyle, while the EHP-30 features subscales relating to relationships with children, medical professionals, and therapy (30).

Data will be analyzed using SPSS 24 software. The normality of quantitative variables will be investigated using the Shapiro–Wilk test. Descriptive statistics, including frequency (percentage), mean (standard deviation) for normal data, and median (25th–75th quartile) for non-normal data, will be used to describe participants’ sociodemographic and reproductive characteristics of affected women. Bivariate tests, including Pearson's or Spearman's correlation, will be used to determine the relationship between a health-promoting lifestyle and its subdomains and the impacts of endometriosis on various aspects of women's lives. P < 0.05 will be considered statistically significant.

Based on the results of the average score for overall health-promoting lifestyle and the effects of endometriosis obtained in the quantitative section, participants in the qualitative part consisted of extreme cases (31), that is, those who will gain 10% of the upper and lower limits of the overall health-promoting lifestyle in the quantitative part will be selected. The Consolidated Criteria for Reporting Qualitative (COREQ) checklist will be used for reporting the results of this study. A conventional qualitative content analysis approach will be adopted, which allows for obtaining direct information from a study without imposing preconceived categories or theories.

To collect qualitative data, semi-structured in-depth interviews with open-ended questions will be conducted. During the interviews, the researchers must encourage participants to express their views and experiences freely (31). Prior to the qualitative stage, an interview guide will be developed by designing questions based on the findings of the quantitative phase and related factors. To obtain credible data, the researchers must begin the interviews with predesigned questions, analyze responses to each question, and raise in-depth and exploratory questions such as “What do you mean?”, “Why?”, “Please explain further,” and “Please give an example.” All interviews will be conducted in health centers chosen by the participants. Sampling continued until data saturation is reached, that is, until no new information or code is received (32).

A conventional qualitative content analysis approach will be adopted to analyze the data. In this approach, the researchers read and interpret all available texts to gain a complete understanding of them. Then, the texts are examined word-for-word to extract relevant codes. The main advantage of this approach is obtaining direct information from a study without imposing preconceived categories or theories (33). Data will be analyzed based on a qualitative content analysis method introduced by Graneheim and Lundman (34). This method allows for extracting not only the explicit content of the texts but also their implicit content with varying degrees of abstraction. We will use four criteria to evaluate the accuracy of the qualitative data (credibility, dependability, confirmability, and transferability) (35). The interview texts and codes will be organized in MAXQDA 20.

In this study, integration will be used in the design of a health promotion program for women with endometriosis by combining findings from the qualitative and quantitative phases, as presented in the Discussion section. Some researchers who use this method present a paragraph that reports the quantitative results and then continue with a paragraph that deals with the qualitative results. Some also state a descriptive quantitative result and then immediately include a qualitative quote in the same paragraph to confirm the quantitative result (36).

In this study, based on the results of the quantitative stage and the codes that will be explained based on the needs and challenges of the affected women in the qualitative stage, it should be determined to what extent the data obtained from the studies are aligned or inconsistent and to what extent the data obtained from the two phases of the study support each other or are in conflict with each other (39). Then the review of the literature will be done, and the extraction of needs will be done at the same time. The extracted needs are again confirmed by the participants and listed based on the participants’ prioritization. Based on the categories of needs, solutions are listed by taking into account the opinions of the participants and available experts related to this issue (reproductive health specialists, midwives, and gynecologists) through a focus group discussion to be used in the third phase by using a logical model to design a health promotion program. A logic model is a program planning tool that defines the inputs, outputs, and results of a program. Logical models are visual tools that can help programs create action plans for activities. It explains the thinking behind program design and shows how specific program activities lead to desired results. Inputs include resources, activities, and investments made in a program. Outputs include activities, services, events, products that reach the main audience of the program, and the results of changes related to the intervention of the program that are experienced by the primary audience (40).

After designing the “health promotion program for women with endometriosis” based on the logical model, validation will be conducted using the “Delphi method.” Obtaining the views and opinions of experts in the field of health is very important for policymakers in a targeted and scientific process.

First stage: The panel of experts will be selected to participate in the activities, the reason and logic of the study will be explained to them, and they will be requested to participate in the study.

Second stage: Each of the participants will be asked to answer to provide a list of value judgments, forecasts, or opinions about the issues or topics determined.

Third stage: The answers will be collected and integrated into a questionnaire for use in the first round of the study. Then the members of the same group are asked to rank the recorded statements in order of priority or importance.

Fourth stage: As soon as all the questionnaires of the participants of the first round are received, the data will be analyzed and analyzed statistically. Then, the statements are readjusted based on the obtained ranks, in the form of another questionnaire to be used in the second round of the study.

Fifth stage: The second round questionnaire, along with the statistical summary of the first stage, is sent to the members of the same group, and they are asked to answer the second questionnaire based on it.

Sixth stage: The fifth stage is repeated for the third round questionnaire. At the end of the third round, the examiner prepares a report of the ranked statements and determines how many changes have been made in the views. Then, the social opinions, along with other related recommendations received from the participants, are summarized and presented to the beneficiaries for decision-making.