The Effect of Mandala Art Therapy on Surgical Fear and the Stress Hormone (Cortisol) in High-risk Pregnant Women Before Cesarean Section.
The Effect of Mandala Art Therapy Applied Before Cesarean Section on Surgical Fear and Cortisol Levels in High-Risk Nulliparous Women: A Randomized Controlled Trial
調査の概要
状態
介入・治療
詳細な説明
This randomized controlled trial is designed to investigate the effect of mandala art therapy applied in the preoperative period on surgical fear and cortisol levels in high-risk nulliparous women scheduled for cesarean section. The study will be conducted with participants meeting inclusion criteria and randomly assigned to intervention and control groups using a randomization method.
The intervention group will receive a structured mandala art therapy session prior to cesarean section, while the control group will receive routine preoperative care. Surgical fear levels will be assessed using a validated scale, and physiological stress will be evaluated through salivary cortisol measurements. The primary outcome of the study is the change in surgical fear levels, while the secondary outcome is the change in cortisol levels. Data will be analyzed using appropriate statistical methods to determine the effectiveness of the intervention.
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 GÜNEY, Associate Professor
- 電話番号：+90 5432064063
- メール：esra.guney@inonu.edu.tr
研究連絡先のバックアップ
- 名前：Melike TAN ÇELİK, midwife
- 電話番号：+90 5452259635
- メール：melike9635@gmail.com
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:
- The study sample will consist of high-risk nulliparous women scheduled for elective cesarean section on the same day. Participants will be included if they are 18 years of age or older, diagnosed with high-risk pregnancy conditions (e.g., preeclampsia, gestational diabetes, placenta previa, oligohydramnios, etc.), at term pregnancy (37-42 weeks gestation), with a singleton pregnancy, and able to understand and complete the data collection forms.
Exclusion Criteria:
- Women with a diagnosed psychiatric disorder, any condition that impairs communication (such as hearing, visual, or language impairments), those receiving systemic corticosteroid therapy, those with endocrine disorders that may affect cortisol levels, and those with active oral lesions such as aphthous ulcers or other oral mucosal lesions will be excluded from 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：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Mandala Art Therapy Group
Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section.
The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery.
The intervention is intended to reduce preoperative surgical fear and psychological stress.
|
Participants allocated to the intervention group will receive mandala art therapy in addition to standard preoperative care before cesarean section.
The intervention will consist of a single structured mandala coloring session lasting approximately 30-45 minutes and will be administered prior to surgery.
The intervention is intended to reduce preoperative surgical fear and psychological stress.
|
|
介入なし：Control Group
Pregnant women in this group will receive routine preoperative care without mandala art therapy.
|
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 |
|---|---|---|
|
Surgical Fear
時間枠：Baseline (before intervention) and immediately prior to cesarean section
|
Surgical fear will be measured using a validated surgical fear scale in high-risk nulliparous women undergoing cesarean section.
|
Baseline (before intervention) and immediately prior to cesarean section
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Salivary Cortisol Level
時間枠：Baseline and immediately prior to cesarean section
|
Salivary cortisol levels will be measured as a physiological indicator of stress in high-risk nulliparous women undergoing cesarean section.
|
Baseline and immediately prior to cesarean section
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター：Ercan Yılmaz, Professor、İnönü University Turgut Özal Medical Center
- 主任研究者：Esra GÜNEY, Associate Professor、İnönü University Faculty of Health Sciences
- スタディディレクター：Melike Tan, midwife、İnönü University Faculty of Health Sciences
出版物と役立つリンク
便利なリンク
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
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。