Roy Adaptation Model-Based Prenatal Education in Hypertensive Pregnant Women
The Effect of Roy Adaptation Model-Based Prenatal Education on Perceived Stress and Quality of Life in Hypertensive Pregnant Women
This study aims to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders of pregnancy.
Pregnant women with hypertensive disorders who meet the eligibility criteria will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will receive prenatal education based on the Roy Adaptation Model in two face-to-face sessions, one week apart. The control group will receive routine antenatal care. Blood pressure monitoring will be recommended for participants in both groups.
Perceived stress and quality of life will be assessed before the education and after the intervention. The study will investigate whether Roy Adaptation Model-based prenatal education helps reduce perceived stress and improve quality of life among pregnant women with hypertensive disorders.
調査の概要
詳細な説明
Hypertensive disorders of pregnancy are high-risk pregnancy conditions that may be associated with various maternal and fetal complications and require close monitoring throughout pregnancy. In pregnant women diagnosed with hypertensive disorders, concerns related to the disease, uncertainty about the course of pregnancy, and concerns about fetal health may increase perceived stress and negatively affect quality of life. Therefore, in addition to medical follow-up, providing education and counseling tailored to the individual needs of pregnant women and supporting their adaptation to pregnancy and the disease are important components of care.
The Roy Adaptation Model is a theoretical model that explains how individuals respond to environmental stimuli and aims to support adaptation through nursing and midwifery care. The model addresses four modes of adaptation: physiological-physical, self-concept, role function, and interdependence. Addressing the effects of the physical and psychosocial changes associated with hypertensive pregnancy on these adaptation modes may contribute to better adaptation to the pregnancy process.
In this study, prenatal education for pregnant women with hypertensive disorders has been developed based on the Roy Adaptation Model. The educational content will include information about hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals. The education will be delivered face-to-face by the researcher in two sessions, with a one-week interval between sessions.
Eligible pregnant women with hypertensive disorders will be randomly assigned to either an intervention group or a control group. The intervention group will receive Roy Adaptation Model-based prenatal education, while the control group will receive routine antenatal care. A blood pressure monitoring chart will be provided to participants in both groups.
Participants' perceived stress levels and quality of life will be assessed at the measurement time points specified in the study protocol. Sociodemographic and obstetric characteristics will also be collected using a researcher-developed introductory information form. Participants in the intervention group will provide feedback regarding the education through an education satisfaction evaluation form.
The primary aim of this study is to evaluate the effect of Roy Adaptation Model-based prenatal education on perceived stress and quality of life in pregnant women with hypertensive disorders. The findings are expected to contribute to the development and implementation of theory-based prenatal education programs tailored to the needs of pregnant women with hypertensive disorders and to support evidence-based midwifery care.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Esra Erdem, midwife
- 電話番号：+90 537 011 59 36
- メール：esra.erdem@ogr.iuc.edu.tr
研究場所
-
-
-
Istanbul、トルコ（Türkiye）、34384
- Prof. Dr. Cemil Taşcıoğlu Şehir Hastanesi
-
コンタクト：
- Esra Erdem, midwife
- 電話番号：yok +90 537 011 59 36
- メール：esra.erdem@ogr.iuc.edu.tr
-
主任研究者：
- Esra Erdem, Midwife
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Pregnant women who apply to the antenatal outpatient clinic of the relevant hospital.
- Women diagnosed by a physician with a hypertensive disorder of pregnancy. Women who are between 20 and 32 weeks of gestation.
- Women aged 18 years or older.
- Primiparous or multiparous pregnant women.
- Women who can read and understand Turkish and communicate in Turkish.
- Women who are willing to participate in the study.
Exclusion Criteria:
- Pregnant women with severe preeclampsia, eclampsia, HELLP syndrome, or a clinical condition requiring emergency obstetric intervention.
- Pregnant women who are hospitalized or scheduled for hospitalization at the beginning of the study.
- Pregnant women diagnosed with fetal anomaly or intrauterine fetal death.
- Pregnant women with severe psychiatric, neurological, or cognitive impairment that may prevent participation in the education sessions or completion of the data collection instruments.
- Pregnant women who develop a serious obstetric or clinical complication during the study that may affect the primary outcomes of the study.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Intervention Group
Participants assigned to the intervention group will first be informed about the study and provide written informed consent.
They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life.
Subsequently, they will receive Roy Adaptation Model-based prenatal education in two face-to-face sessions, one week apart.
Each session will last approximately 45 minutes.
The education will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals.
Participants will also be provided with a blood pressure monitoring chart.
Following the education, post-intervention assessments of perceived stress and quality of life will be conducted.
Finally, participants will complete the Education Satisfaction Evaluation Form.
|
Roy Adaptation Model-based prenatal education will be provided face-to-face by the researcher to pregnant women with hypertensive disorders of pregnancy.
The education will be delivered in two sessions, one week apart, with each session lasting approximately 45 minutes.
The educational content will address hypertensive disorders of pregnancy, blood pressure monitoring, healthy lifestyle behaviors during pregnancy, stress management, adaptation to physical and psychosocial changes during pregnancy, and seeking support from healthcare professionals.
Participants will also receive a blood pressure monitoring chart for home monitoring.
The intervention is specifically structured according to the four adaptive modes of the Roy Adaptation Model: physiological-physical, self-concept, role function, and interdependence.
|
|
介入なし：Control Group
Participants assigned to the control group will first be informed about the study and provide written informed consent.
They will then complete the Introductory Information Form and the pre-intervention assessments of perceived stress and quality of life.
Participants will continue to receive routine antenatal care throughout the study.
They will also be provided with a blood pressure monitoring chart and instructed on blood pressure monitoring.
No Roy Adaptation Model-based prenatal education will be provided to the control group during the study.
At the end of the study follow-up period, the post-intervention assessments of perceived stress and quality of life will be conducted.
|
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 |
|---|---|---|
|
Perceived Stress Level in High-Risk Pregnancies
時間枠：At baseline (before the first education session) and 2 weeks after baseline
|
Perceived stress level will be assessed using the High-Risk Pregnancy Perceived Stress Scale.
Higher scores indicate higher perceived stress.
|
At baseline (before the first education session) and 2 weeks after baseline
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pregnancy-Related Quality of Life Score
時間枠：At baseline (before the first education session) and 2 weeks after baseline
|
Quality of life will be assessed using the Pregnancy Quality of Life Scale.
Higher scores indicate better quality of life.
|
At baseline (before the first education session) and 2 weeks after baseline
|
協力者と研究者
捜査官
- スタディディレクター：Sevda Korkut Öksüz、Istanbul University - Cerrahpasa
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- IUC-EBELİK-EE-01
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?
IPD プランの説明
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
米国FDA規制機器製品の研究
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。