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"Menopause Experiences in Cultural and Intercultural Contexts" (VIMEC-IC)

"Menopause Experiences in Intercultural Contexts and Healthcare Professionals: A Mixed- Methods Study Protocol in Community Settings"

The climacteric period involves physical, hormonal, and emotional changes that can impact a woman's quality of life. This mixed-methods study aims to explore the perceptions and experiences of women during menopause and the influence of cultural ethnicity on their quality of life in Primary Care centers in Tarragona. The research includes a quantitative phase to assess healthcare professionals' knowledge via electronic surveys and a qualitative phase using individual interviews with women from diverse backgrounds. The goal is to identify specific needs to adapt community nursing interventions and improve health promotion and equity during the climacteric stage.

調査の概要

詳細な説明

This study employs a mixed-methods approach to provide a comprehensive understanding of the climacteric process in the health area of Tarragona. The research is divided into two distinct but complementary phases:

  1. Quantitative Phase (Cross-sectional Descriptive Study):

    The objective is to evaluate the level of knowledge and the attitudes of healthcare professionals (nurses and physicians) regarding menopause management.

    Data Collection: An ad hoc questionnaire will be distributed electronically through the corporate email systems of the Primary Care centers (ICS).

    Variables: Sociodemographic data, professional profile, and specific knowledge scores on menopause, Mediterranean diet, and physical activity recommendations.

    Analysis: Descriptive and inferential statistics will be performed using IBM SPSS Statistics.

  2. Qualitative Phase (Phenomenological Approach):

The objective is to explore the lived experiences, perceptions, and cultural influences of women in the climacteric stage.

Data Collection: Semi-structured individual interviews will be conducted with women from diverse sociocultural and ethnic backgrounds to ensure maximum variation.

Sampling: Purposeful sampling will be used until data saturation is reached.

Analysis: All interviews will be transcribed verbatim and analyzed using thematic analysis with the support of Atlas.ti software.

Ethics and Integration:

The study follows the Declaration of Helsinki and has been approved by the Ethics Committee (IDIAP Jordi Gol). Data from both phases will be integrated to identify specific gaps in clinical practice and the real-world needs of women, aiming to design better community nursing interventions.

研究の種類

観察的

入学 (推定)

25

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

  • 名前:Rocío Legaz Pagán, PhD Student, RN, BcS
  • 電話番号:0034 +34646057662
  • メールrlegazpagan39@gmail.com

研究連絡先のバックアップ

研究場所

      • Tarragona、スペイン
        • 募集
        • Institut Català de la Salut (ICS) - Camp de Tarragona.
        • コンタクト:
        • コンタクト:
        • 主任研究者:
          • Rocío Legaz Pagán, RN, BcS, PhD Student
        • 副調査官:
          • Marina Gómez de Quero Cordoba, RN, MSN, PhD
        • 副調査官:
          • Rosa Raventós Torner, RN, MSN, PhD
        • 副調査官:
          • Cristina Rey Reñones, RN, MSN, PhD

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

The study population consists of two main groups located in the Tarragona healthcare area:

Healthcare Professionals: Nurses and physicians working in Primary Care centers (Institut Català de la Salut) who provide care to women during the climacteric stage.

Women in the Climacteric Stage: Women aged 40 to 65 years from diverse sociocultural and ethnic backgrounds who are users of the Primary Care centers in the same geographical area.

The sample will be drawn from urban and rural health centers to ensure a representative professional perspective and a diverse range of lived experiences from the women interviewed.

説明

Inclusion Criteria:

For professionals:

  • Healthcare professional aged 18 years or older.
  • Currently working in the Primary Care setting.
  • Provide care or work with women in the climateric stage.
  • Agreement to participate and completion of the anonymous survey after providing informed consent.

For Women (Qualitative Phase):

  • Women aged 40 to 65 years.
  • Currently in the climacteric stage (perimenopause or postmenopause).
  • Belonging to diverse sociocultural or ethnic backgrounds.
  • Ability to communicate and provide informed consent for the individual interview.

Exclusion Criteria:

For porfessionals:

*Refusal to participate in the study or incomplete electronic survey.

For Women (Qualitative Phase):

  • Inability to understand the study's language (Spanish or Catalan).
  • Cognitive impairment that prevents the participant from providing informed consent or participating in the interview/survey.
  • Refusal to participate in the study.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
介入・治療
Healthcare Professionals
Primary care nurses and physicians working in the health centers of Tarragona (ICS). This group will participate in the quantitative phase by completing an online survey about their knowledge and attitudes toward menopause.

For Professionals: An electronic questionnaire to assess knowledge and attitudes toward menopause.

For Women: A qualitative semi-structured interview to explore their perceptions and lived experiences during the climacteric stage.

Women in Climacteric Stage
Women aged between 40 and 65 years from diverse sociocultural and ethnic backgrounds. This group will participate in the qualitative phase through individual semi-structured interviews to explore their experiences and quality of life.

For Professionals: An electronic questionnaire to assess knowledge and attitudes toward menopause.

For Women: A qualitative semi-structured interview to explore their perceptions and lived experiences during the climacteric stage.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Perceptions and Lived Experiences of Women in the Climacteric Stage.
時間枠:Baseline.
Exploration of the subjective experiences, cultural influences, and quality of life through thematic analysis of semi-structured interviews.
Baseline.
Level of Knowledge and Attitudes of Healthcare Professionals Regarding Menopause.
時間枠:Baseline at the time of survey completion.
Evaluation of knowledge scores and professional attitudes towards menopause management through an ad hoc electronic questionnaire. The questionnaire provides a total score ranging from 0 to10, where 0 indicates the lowest level of knowledge and poorest attitude, and 10 indicates the highest level of knowledge and most positive attitude towards menopause management.
Baseline at the time of survey completion.

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

捜査官

  • スタディチェア:Rosa Raventós Torner, RN, MSN, PhD、Universidad Rovira i Virgili
  • スタディディレクター:Cristina Rey Reñones, RN, MSN, PhD、Universidad Rovira Y Virgili
  • 主任研究者:Rocío Legaz Pagán, PhD Student, RN, MSc、Universidad Rovira Y Virgili
  • スタディディレクター:Marina Gómez de Quero Cordoba, RN, MSN, PhD、Universidad Rovira Y Virgili

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月27日

一次修了 (推定)

2028年4月22日

研究の完了 (推定)

2030年4月22日

試験登録日

最初に提出

2026年5月29日

QC基準を満たした最初の提出物

2026年6月12日

最初の投稿 (実際)

2026年6月15日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月15日

QC基準を満たした最後の更新が送信されました

2026年6月12日

最終確認日

2026年5月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

"Individual participant data will not be shared to protect the confidentiality and anonymity of the participants, in accordance with the informed consent and Spanish data protection laws (LOPDGDD 3/2018)."

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

有効な MeSH 条件の臨床試験

Survey and Semi-structured Interviewの臨床試験

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