化学療法を受けている小児の口腔粘膜炎の程度に対する重炭酸ナトリウム、生理食塩水、黒桑シロップの影響
化学療法を受けている小児の口腔粘膜炎の程度に対する重炭酸ナトリウム、生理食塩水、黒桑シロップの影響：ランダム化比較試験
This study was planned as a randomized controlled experimental study in order to compare the effects of oral care with saline and black mulberry syrup in addition to sodium bicarbonate on oral mucositis level in children aged 6-18 years receiving chemotherapy.
調査の概要
状態
詳細な説明
Oral mucositis, also known as stomatitis, is the most common complication of cancer treatment. Mucositis affects the patient's nutrition, daily functions, and quality of life, may compromise the ability to tolerate scheduled therapy. For this reason, the children to be included in the study will be randomly divided into three groups. Sodium bicarbonate, which is the routine care in the clinic, will be administered to the control group, and to the intervention groups, saline in addition to the routine care and black mulberry syrup will be applied in addition to the routine care. Data will be collected according to Patient Information Form, International Child Mucositis Assessment Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts. Oral care will be applied to the groups 4 times a day for 14 days. The International Child Mucositis Rating Scale (ChIMES), World Health Organization Mucositis Classification and neutrophil counts will be evaluated by the researchers on the 1st, 2nd, 4th, 8th and 16th days.
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：Selda Ateş Beşirik, Assistant Professor
- 電話番号：+905543683323
- メール：seldaates07@gmail.com
研究場所
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-
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Isparta、トルコ（Türkiye）
- 募集
- Isparta City Hospital
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コンタクト：
- Selda Ateş Beşirik, Assistant Prof.
- 電話番号：+905543683323
- メール：seldaates07@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- The willingness of the family and the child to participate in the study
- Parent and child have separately informed written consent form
- Be between 6-18 years old
- Receiving chemotherapy and being hospitalized for chemotherapy treatment
- Being fed orally
Exclusion Criteria:
- Oral mucositis in the first intraoral evaluation
- Having diabetes
- Receiving radiotherapy
- Having a surgical procedure in the mouth and jaw area
- Receiving steroid therapy during chemotherapy treatment
- Using a method other than the methods used in the study to protect the oral mucous membrane throughout 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：防止
- 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 |
|---|---|
|
プラセボコンパレーター：Sodium Bicarbonate Group (Usual care)
General routine oral care. In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group will receive routine oral care in the clinic with sodium bicarbonate. It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night. |
In the clinic where the research was conducted, a guideline is routinely applied for the care of oral mucositis in line with the stages of oral mucositis. Sodium bicarbonate is used in line with this guideline. The first group, the control group, will receive routine oral care in the clinic with sodium bicarbonate. Oral care will be applied 4 times a day for 14 days. |
|
実験的：Saline Group
It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night. |
The second group, the experimental group, will first receive oral care routinely applied in the clinic. Then, oral care will be given in the form of 5 ml mouthwash with saline. Oral care will be applied 4 times a day for 14 days. |
|
実験的：Black Mulberry Syrup Group
It will be applied as a 5 ml mouthwash four times a day, after meals and before going to bed at night. |
The third group, the experimental group, will first receive oral care routinely applied in the clinic. Then black mulberry syrup will be applied. Then, oral care will be given in the form of 5 ml mouthwash with black mulberry syrup. Oral care will be applied 4 times a day for 14 days. |
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 |
|---|---|---|
|
Children's International Mucositis Evaluation Scale
時間枠：up to 16 days
|
Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions. |
up to 16 days
|
|
Oral Mucositis Evaluation Index of the World Health Organization
時間枠：up to 16 days
|
It is scored between zero and four points. Although there is no change in the grade-0 mucosa, grade-1 painless ulcers, erythema or mild sensitivity, grade-2 painful erythema and ulcers, solid foods can be consumed. Grade-3 painful erythema, edema or ulcer can be consumed only, grade-4 ulceration, necrosis and hemorrhage are present, the patient cannot be fed, enteral or parenteral support is required. |
up to 16 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Neutrophil count
時間枠：up to 16 days
|
The neutrophil count will be evaluated. Numbers will be recorded. |
up to 16 days
|
協力者と研究者
捜査官
- 主任研究者：Selda Ateş Beşirik, Assistant Professor、Burdur Mehmet Akif Ersoy University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
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。