This study employs a multistage combined design conducted in a sequential exploratory fashion. Qualitative data will precede the quantitative phase. We will conduct qualitative research in the initial stage using a contractual content analysis approach. Our goal is to elucidate the needs and concerns of three distinct groups: women seeking GCS, women who have already undergone such procedures, and the partners of these women. Furthermore, we will conduct a literature review during this stage to investigate the global needs and concerns of women considering GCS. In the second stage, we will consider the primary priorities identified in the preceding step to develop the intervention. We will review relevant texts to extract the necessary interventions, plans, recommendations, and strategies to address the needs and concerns of women seeking GCS in Iran and other countries. The final intervention will be chosen through a nominal group meeting attended by experts actively engaged in sexual and reproductive health. Before convening the expert panel for the target group, we will outline the goals and initial content of the interventions with guidance from esteemed professors and advisors. Subsequently, the initial format of the designed interventions will be provided to the experts for evaluation, concurrent with the prioritization of needs and concerns during the expert panel meeting. The selected, qualified intervention will then be implemented in the quantitative phase. The third stage will involve a quantitative study to evaluate and assess the effectiveness of the intervention designed to address the needs and concerns of women seeking genital cosmetic surgeries. We will compile the objectives of the quantitative section based on the identified content and the type of intervention.

Phase I: qualitative study

We will conduct an initial qualitative study using a contractual content analysis approach during this stage. The primary goal is to elucidate the needs and concerns of women considering cosmetic surgery of the genital tract, including those who have already undergone the procedure, as well as the partners of these women. Additionally, as part of this research phase, we will conduct a comprehensive literature review to investigate the needs and concerns of women seeking GCS globally.

Participants

To evaluate the needs and concerns of women in this context, we will conduct semi-structured, in-depth individual interviews. These interviews will involve married women between 18 and 49 who have either sought GCS or undergone such procedures. We will also include their spouses willing to participate in the interview sessions.

Inclusion criteria

The inclusion criteria for this study encompass women actively seeking GCS, women with a history of GCS, spouses of female applicants, individuals who are married, fall within the reproductive age range (18–49 years), do not have a diagnosed physical or mental illness, are literate in reading and writing, and are proficient in speaking both Persian and Turkish languages.

Sampling

In the qualitative study, the research population will be drawn from individuals with experience or knowledge relevant to the topic under investigation. Specifically, in this qualitative phase of the study, we will target women attending gynecological clinics at Tabriz University of Medical Sciences and Tehran University of Medical Sciences who possess basic literacy skills in reading and writing. Our sampling approach aims to attain maximum diversity among participants. Selection will be based on various factors, including age, education level, socio-economic status, number of pregnancies and births, and marital status (widowed, single, and married). Sampling will continue until a sufficient amount of data is collected.

Research environment

Interviews will be arranged at the convenience of the participants and conducted in locations where they feel comfortable and trust the interviewer. These settings may include hospitals, health complexes associated with the University of Medical Sciences, clinics, universities, participants' homes, and similar locations.

Data collection process

Data collection will commence upon obtaining approval for the research plan and receiving ethical clearance from the Joint Ethics Committee of the Faculty of Nursing and Midwifery and the Faculty of Rehabilitation. Additionally, a written letter of introduction will be obtained from both Tehran University of Medical Sciences and Tabriz University of Medical Sciences.

The initial data collection phase will involve in-depth interviews with women with a GCS history and willing participants' spouses. These interviews will follow an interview guide. The number of interview sessions will be determined based on individual participant conditions and responses to the research questions. Before the interview, the researcher will ask the participants to review and sign the informed consent form. Interviews will be scheduled at a time and location preferred by the participants, ensuring their comfort and upholding principles of privacy and confidentiality.

Establishing effective communication with the participants is crucial at the interview's outset. This approach can be achieved by providing a brief, understandable explanation of the significance of the research, which helps build trust before delving into the interview. All interview transcripts will undergo anonymization, and the interview recordings will be identified with numerical codes to safeguard privacy. Participants will receive assurance that their information will remain confidential and that their names will not be disclosed. Subsequently, participants will be invited to discuss their needs and concerns related to their genital area. Follow-up questions will be tailored based on initial responses and the interview guide. If necessary, probing questions like "What do you mean?" or "Could you elaborate further?" may be used during the interview. As the study progresses, interview questions may be adjusted or new ones added based on emerging themes and researcher inquiries. Indeed, here are the interview questions:

1.

What prompted your interest in pursuing GCS, and what specific goals are you aiming to achieve through this procedure?

2.

Could you share the primary motivation behind your decision to undergo GCS?

3.

Did any external influences, such as your spouse, family, friends, media exposure, or medical professionals, play a role in your decision-making process?

4.

From your perspective, why do you believe some women opt for cosmetic surgery on their genitals?

5.

What are your expectations regarding the outcomes of this surgery, particularly concerning its potential effects on reproductive health and your sexual well-being?

6.

Could you elaborate on your expectations and what you hope to achieve through this surgery?

7.

Regarding the concerns that led you to consider this surgery, do you believe they can be assessed before the procedure, or do you anticipate addressing them afterward?

8.

Would you like to discuss or express any specific worries or considerations related to the surgery?

Once the interview questions have been addressed, participants can share any additional thoughts or concerns. Towards the interview's conclusion, we will explore the potential for further discussions if necessary. All interviews will be recorded and transcribed verbatim, with the participant's permission. We prioritize confidentiality, and as a measure to ensure accuracy, we will provide the interview text to the participant for their review and confirmation.

Data analysis

In the qualitative phase of this study, data analysis will be conducted using the content analysis approach facilitated by MAXQDA software version 12. Our approach is conventional content analysis, an inductive method for analyzing textual data. This method is one among several research techniques used for text analysis.

The recorded interviews will be transcribed verbatim, and the text will undergo thorough and repeated analysis to ensure the researcher's deep immersion in the data. Analysis units will be identified, classified, and coded. Determining the analysis units is critical in content analysis, as they constitute the primary content within the texts under examination. The research team, including the supervisor and advisor, will review and validate the data classification and coding. Codes will be organized into classes and subclasses and assigned to their respective categories based on semantic and content similarities after undergoing multiple rounds of review.

In the subsequent stage, code stability within the text will be validated through testing and obtaining consensus among most research team members. Two external experts with experience will review the codes assigned to the categories and subcategories to ensure coding stability. The following stage will conclude the accurate categorization of data and the given codes. The characteristics and relationships within and between categories will be examined and analyzed. Each category and subcategory will be explored alongside the interview text, and ultimately, the formed categories will be interpreted and reported.

Accuracy and reliability of qualitative data

In the current study, various criteria, such as validity, reliability, verifiability, transferability, and accuracy, will be employed to ensure the accuracy of qualitative data.

The researcher will actively collect and analyze data for an extended period to enhance validity. They will establish a strong rapport with participants by thoroughly reviewing and critically examining the interviews. Additionally, the research team will incorporate data revised by participants and team members, ensuring maximum diversity in socio-economic status. These measures will contribute to the research's validity.

To achieve and enhance reliability, the research team and external observers will develop, pilot, and refine the interview guide, coding, and analysis processes multiple times. This iterative approach aims to comprehensively address women's needs and concerns in the reproductive health field.

To ensure verifiability, which entails reflecting the participants' voices rather than the researchers' biases, the researcher will seek input from two external experts knowledgeable about qualitative research methods. These experts will provide feedback on the text coding process and interpretations made during several interviews.

Lastly, to ensure transferability, which refers to the generalizability of the study, efforts will be made to collect information from participants with diverse characteristics, including literacy, age, and socio-economic status. This approach will enhance the study's ability to apply findings to a broader context.

Phase II: designing interventional program

During the study's second phase, we will undertake a two-step process to formulate an intervention that addresses the needs and apprehensions of women considering cosmetic surgery for their genital area. These steps involve:

Textual analysis and review

This stage is the primary prioritization of concerns and the development of appropriate interventions. In the second phase, we will assess interventions and programs related to the needs and concerns associated with GCS, both in Iran and other countries. To ensure a comprehensive search, we have utilized various databases, such as SID, Magiran, Iran Medex, ProQuest, PubMed, Web of Science, Scopus, Sage, and Embase. Our investigation encompasses the period from the year 2000 up to September 2023. We have conducted database searches using diverse combinations of keywords in both Persian and their corresponding Latin equivalents. These keywords encompass "genital cosmetic surgery," "sexual health," "women," "labiaplasty," "genital self-image," "qualitative research," "mixed method," "female," "anesthetic surgery," and "genital self-image."

Conducting an expert panel discussion

Based on the first-stage research findings, the panel of experts will prioritize identified needs and concerns. The development of the intervention will heavily rely on the opinions of these experts, with a focus on the most crucial interventions and programs. Before convening the expert panel meeting for the target group, the research team, guided by esteemed professors and advisors, will define the goals and initial content of the interventions addressing these needs and concerns. Subsequently, the preliminary format of the designed interventions will be presented to the experts during the panel meeting. During this meeting, experts will prioritize the identified needs and concerns concurrently. The highest quality intervention will then be implemented in the quantitative phase. An expert meeting will be organized and conducted as a nominal group, and small group discussions (Focus Groups) will be structured to address this. This meeting will involve experienced experts with a history of providing services in sexual and reproductive health, specifically women's health. The participants will include specialists in reproductive health, psychiatrists, gynecologists, midwives, nurses, and psychologists.

Utilizing the Focus Group approach is essential, as it facilitates the extraction of diverse ideas and opinions and encourages collective thinking. This approach is precious in shaping the intervention to address concerns related to women seeking cosmetic surgeries for the genital system.

The Template for Intervention Description and Replication (TIDieR) tool will assess the designed intervention [17]. Given the need for a comprehensive intervention description to make informed selections, we will utilize the TIDieR checklist and model guide to detail and replicate the intervention. The TIDieR checklist comprises 12 essential items:

1.

Brief name: provides a succinct name or phrase describing the intervention.

2.

Why: explains the underlying logic, theory, or purpose of essential intervention components.

3.

What (materials): describes any physical or informational materials used in the intervention, including those provided to participants or used in its delivery.

4.

What (procedure): details the location, strategies, activities, and processes involved, including any supportive activities.

5.

Who provided: specifies the expertise, background, and specific training of intervention providers.

6.

How: describe the delivery methods (e.g., face-to-face or online) and whether they are individual- or group-based.

7.

Where: identifies the locations where the intervention occurs, including necessary infrastructure.

8.

How much: addresses the intervention's quantity or dose.

9.

When: specifies the frequency of the intervention.

10.

Tailoring: focuses on customizing intervention details, such as session duration, frequency, and intensity.

11.

Modification: describes any adaptations or changes made during the study, including reasons, timing, and implementation.

12.

How well (planned): discuss methods for assessing adherence to the intervention and strategies for maintaining or improving compliance.

The checklist enhances the reporting process and repeatability of interventions, ensuring that the most suitable intervention is selected through quantitative evaluation by a group of experts. Before this research's quantitative stage, 8 to 10 field experts will complete and review the checklist to assess the intervention thoroughly.

Phase III: quantitative studyType and approach

In the quantitative phase of this mixed-method research, a semi-experimental trial will be conducted, comprising both intervention and control groups. This phase, the second stage of the study, will primarily concentrate on the quantitative aspect, specifically the intervention test.

The third stage of this research involves a quantitative clinical trial. Its objective is to evaluate the effectiveness of the intervention designed to address the needs and concerns of women seeking cosmetic surgery for the genital system.

Population

In this study stage, the participants will be chosen from married women aged 18–49. These women will attend women's clinics at hospitals affiliated with Tabriz University of Medical Sciences and Tehran University of Medical Sciences.

Inclusion criteria

To participate in the trial phase of the study, individuals must meet the following criteria:

1.

Absence of physical or mental illnesses or the use of specific medications

2.

Possess minimal literacy

3.

Express a desire to take part in the study

4.

Not be pregnant

5.

Not be breastfeeding

Exclusion criteria

Participants will be excluded from the quantitative phase of the study if they meet any of the following criteria:

1.

Congenital disabilities of the genital system.

2.

History of burns or cancer in the genital area.

3.

Various degrees of female circumcision.

4.

Confirmed sexual dysfunction (FSFI ≤ 26).

5.

Multiple degrees of pelvic organ prolapse.

6.

Non-cooperation of participants in continuing to attend training sessions.

7.

Occurrence of pregnancy during the course.

Research sample

In this research stage, the sample will comprise married women who visit women's clinics at hospitals affiliated with Tabriz and Tehran Universities of Medical Sciences. These women have expressed concerns and anxiety about their genital area and are seeking cosmetic surgery for this specific concern.

Research environment

The research will be conducted in women's clinics within educational hospitals affiliated with Tabriz and Tehran Universities of Medical Sciences. In cases where access to eligible participants in government centers may be challenging, sampling from private sectors will be explored because most of these surgeries are performed in private centers. Additionally, posters will be displayed at epilation and laser hair removal centers to maximize participant recruitment, inviting individuals to participate in the study.

Sample size

The sample size for this study was determined using G-Power software, considering various aspects of genital self-image. Referring to the research conducted by Weitkamp et al. [18], with values M1 = 29.09, M2 = 24.11 (assuming a 20% increase due to the intervention's impact), SD1 = SD2 = 3.22, a two-sided α of 0.05, and a Power of 90%, the sample size for each group was initially computed as 15. The final sample size for each group was established at 17 individuals to accommodate a potential 10% dropout rate.

Sampling method and randomization

The researcher will initiate the process by obtaining ethical approvals from the Tehran University of Medical Sciences. Following this, they will secure the required legal documents and permits from the Medical Vice-Chancellor of Tabriz and Tehran Universities of Medical Sciences. If necessary, this will allow them to conduct sampling within hospitals, clinics, and facilities under the university's jurisdiction, including private properties.

Subsequently, the researcher will visit the gynecological clinics within these facilities. In collaboration with the department head and resident urogynecology specialist, they will identify individuals seeking GCS within this clinical setting.

The initial sampling will employ a convenience sampling method, with individuals expressing an interest in participating in the study. They were subsequently screened against the eligibility criteria. Eligible participants will then be categorized into two groups: the intervention group, which will receive education tailored to address genital area needs and concerns, and the control group, which will receive sexual health and reproductive education.

An independent individual not involved in the research will generate an allocation sequence using a computer program (randomizer) to allocate participants. The allocation process will be concealed by writing the type of training assigned to each participant on paper, which will then be sealed inside consecutively numbered opaque envelopes.

Following the entry of each eligible participant into the Study (after obtaining informed consent and collecting primary data), the envelopes will be opened sequentially, and the participant will be assigned to a group according to the order of entry into the study.

Participant recruitment and data collection

Upon identifying eligible participants, informed consent will be obtained, and the participants will proceed to complete the study questionnaires. Given that many genital cosmetic surgeries are conducted in hospitals and private clinics, the researcher will initiate sampling in these facilities after making the necessary arrangements in case access to potential participants in these settings is limited.

Following the intervention sessions in both the intervention and control groups, changes in the participants' awareness and attitudes regarding the decision to undergo cosmetic surgeries will be reassessed.

Regarding blinding, this study will employ one-way blinding. Due to the nature of the intervention, it is not feasible to blind the researcher or the participant. However, to ensure the blinding of the outcome assessor, the questionnaires will be administered and completed by the researcher's assistant.

Study variables and outcomes

After the trial phase, the following variables and outcomes will be examined:

Independent Variables (Educational Interventions): These are the interventions designed and implemented as part of the study.

Dependent Variable: The primary dependent variable is the decision to undergo or refrain from GCS, which will be assessed at the end of the trial phase.

Primary outcomes

Intention to undergo or actual performance of genital cosmetic surgeries.

Secondary outcomes. 1.

Women's Female Sexual Function Index (FSFI) before and after the intervention.

2.

Women's Female Genital Self-Image Scale (FGSIS) before and after the intervention

Data collection process

Attitudes toward GCS: Participants' attitudes and opinions regarding GCS will be assessed using items developed during the qualitative phase of the study. These items will provide insights into participant's perceptions and concerns regarding these procedures.

In the quantitative phase of this study, we will employ a researcher-developed questionnaire, which has been meticulously designed and validated based on the findings from the qualitative phase. After securing informed consent, we will initiate data collection using this questionnaire. The initial data will encompass participants' demographic, sexual, and reproductive characteristics. Additionally, participants will be asked to complete the standard FSFI [19] to assess sexual function and genital self-image to evaluate by using the FGSIS [20].

1.

The FSFI is comprised of 19 items categorized into six sub-domains, each assigned a specific weight or coefficient. These sub-domains include sexual desire (2 items with a coefficient of 0.6), sexual arousal and orgasm (4 items with a coefficient of 0.3 each), orgasm and satisfaction (3 items with a coefficient of 0.4 each), and pain (2 items with a coefficient of 4/0). Participants will respond on a Likert scale ranging from 0 to 5. A score of zero signifies no sexual activity within the past 4 weeks. After applying the coefficients, the overall score will fall between 2 and 36, with a lower score (FSFI ≤ 26) indicating less favorable sexual performance [21].

2.

FGSI is a 7-item patient-reported assessment tool designed to evaluate one's genital self-image. Participants rate each FGSIS item using a 4-point Likert-type scale, with options ranging from 1 (strongly disagree) to 4 (strongly agree). The individual item scores are summed to calculate the total score, falling within a range of 7–28 points. Higher total scores on the FGSIS signify a more positive genital self-image [22].

3.

The demographic profile questionnaire will encompass inquiries related to socio-economic status, including age, marital status, educational background, occupation, income, number of pregnancies and deliveries, and any history of illness or medication usage.

Furthermore, data collection will include an assessment of participants' attitudes toward undergoing GCS. The questions for this assessment were formulated during the qualitative phase of the study.

Analysis approach

Analyzing the gathered data is vital in deriving valuable insights from it. We will employ descriptive statistics to analyze the collected data, including the mean, standard deviation, minimum, and maximum measures. Additionally, we will utilize inferential statistics methods such as independent t-tests, analysis of covariance, paired t-tests, chi-square tests, Fisher's exact test, and Mann–Whitney tests. This comprehensive analysis will be conducted using SPSS software.