Oral Care Interventions in PEG-Fed Palliative Care Patients (PEG-ORAL)
Effects of Oral Care Interventions on Oral Mucosal Integrity in Palliative Care Patients Receiving Enteral Nutrition Via Percutaneous Endoscopic Gastrostomy: A Three-Arm Pilot Randomized Controlled Trial
This pilot randomized controlled trial will compare three oral care interventions in adult palliative care patients who receive enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube. The purpose of the study is to determine how these oral care interventions affect the health and integrity of the oral mucosa.
Participants will be randomly assigned to one of three groups: oral care with Ankaferd Hemostat, benzydamine hydrochloride, or a combined solution containing methylprednisolone, ceftriaxone, and sodium bicarbonate. Oral care will be provided by trained nurses according to a standardized protocol.
Participants' mouths will be assessed at the beginning of the study and on days 7 and 15. These assessments will include examination of the oral mucosa and standardized photographs of the mouth. Relevant clinical and laboratory information available as part of routine patient care will also be recorded. The findings will be used to compare changes in oral mucosal health among the three groups.
調査の概要
状態
詳細な説明
Patients receiving enteral nutrition through a percutaneous endoscopic gastrostomy (PEG) tube may experience oral health problems because of reduced oral intake, underlying disease, functional limitations, and dependence on oral care. Maintaining oral mucosal integrity is therefore an important component of nursing care in palliative care settings.
This pilot study will evaluate and compare three oral care interventions used in clinical practice in PEG-fed palliative care patients. The study will focus on changes in oral mucosal integrity, including erythema and ulceration. The findings will provide preliminary information on the effects of these interventions and may help inform the design of a future larger randomized controlled trial.
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：Yasemin Karacan, PhD
- 電話番号：05327141814
- メール：jblacksoul@yahoo.com
研究連絡先のバックアップ
- 名前：Irem Ozturk Bardak, RN
- メール：irem.ozturk@yalova.edu.tr
参加基準
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
説明
Inclusion Criteria:
Aged 18 years or older Hospitalized in the palliative care unit Receiving enteral nutrition via percutaneous endoscopic gastrostomy (PEG) and expected to continue PEG feeding during the study follow-up period Able to undergo baseline oral cavity assessment No clinical condition preventing the planned oral care intervention No known allergy or hypersensitivity to the components of the assigned oral care intervention Written informed consent provided by the patient or legally authorized representative
Exclusion Criteria:
Active severe bleeding in the oral cavity Extensive traumatic or surgical lesions in the oral cavity that prevent implementation of the oral care intervention Severe oral mucositis or oral tissue necrosis that prevents implementation of the intervention Uncontrolled bleeding risk or clinically significant coagulopathy Terminal agitation or clinical instability that prevents safe implementation of oral care Development of a clinical condition during follow-up that requires discontinuation of the assigned oral care intervention
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 |
|---|---|
|
実験的：Arm 1 - Ankaferd Hemostat
Arm 1 - Ankaferd Hemostat Participants assigned to this arm will receive standardized oral care followed by topical application of Ankaferd Hemostat.
For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL.
The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days.
The solution will not be swallowed.
|
Ankaferd Hemostat will be used as a topical oral care intervention.
For each application, 1 mL of Ankaferd Hemostat will be mixed with 4 mL of sterile water to obtain a total volume of 5 mL.
The prepared solution will be applied to the oral mucosal surfaces by a trained nurse twice daily, approximately 12 hours apart, for 15 days.
The solution will not be swallowed.
|
|
実験的：Arm 2 - Benzydamine Hydrochloride
Arm 2 - Benzydamine Hydrochloride Participants assigned to this arm will receive standardized oral care followed by topical application of 0.15% benzydamine hydrochloride.
The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days.
Because participants are fed through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.
|
Benzydamine hydrochloride 0.15% will be used as a topical oral care intervention.
The solution will be applied to the oral mucosal surfaces by trained nurses twice daily for 15 days.
Because participants receive enteral nutrition through PEG and may have an increased risk of aspiration, the solution will not be used as a gargle and will not be swallowed.
|
|
実験的：Arm 3 - Combined Oral Care Solution
Arm 3 - Combined Oral Care Solution Participants assigned to this arm will receive standardized oral care followed by topical application of a combined solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate.
The final solution volume will be 25 mL and will be prepared with normal saline according to the standardized clinical preparation procedure.
The solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days.
The solution will not be swallowed.
|
A combined oral care solution containing 40 mg methylprednisolone, 1000 mg ceftriaxone, and 0.84 g sodium bicarbonate will be used as a topical oral care intervention.
Ceftriaxone will be diluted with 10 mL normal saline, methylprednisolone with 5 mL normal saline, and sodium bicarbonate will be added to obtain a final volume of 25 mL.
The prepared solution will be applied to the oral mucosal surfaces by trained nurses twice daily, approximately 12 hours apart, for 15 days.
The solution will not be swallowed.
|
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 |
|---|---|---|
|
Change in Oral Mucositis Assessment Scale (OMAS) Score
時間枠：Baseline (Day 0), Day 7, and Day 15
|
Oral mucosal integrity will be assessed using the Oral Mucositis Assessment Scale (OMAS), which evaluates ulceration/pseudomembrane and erythema at predefined oral sites.
Ulceration is scored from 0 to 3 and erythema from 0 to 2, with higher scores indicating greater oral mucosal damage.
|
Baseline (Day 0), Day 7, and Day 15
|
協力者と研究者
出版物と役立つリンク
一般刊行物
- Sonis ST, Eilers JP, Epstein JB, et al. Validation of a new scoring system for the assessment of clinical trial research of oral mucositis induced by radiation or chemotherapy. Cancer. 1999;85(10):2103-2113. PMID: 10326686 Epstein JB, Silverman S Jr, Paggiarino DA, et al. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001;92(4):875-885. PMID: 11550161 Puhar I, Paleško Tubikanec T, Glavina S, et al. Effect of Benzydamine Hydrochloride on Dental Plaque Accumulation During Short-Term Restricted Oral Hygiene: A Randomized, Placebo-Controlled Trial. Pharmaceuticals. 2026;19:1013. Berk D, Durna Z, Akın S. Kemoterapi uygulanan kanser hastalarında ağız bakımı uygulamaları ve ağız bakım alışkanlıklarının değerlendirilmesi. Sağlık ve Toplum. 2020;30(2):54-63. Kasnak G, Fıratlı HE. Antimikrobik gargara kullanımının ağız mikrobiyotasına etkisi. In: Altındiş M, ed. Ağız Mikrobiyotası. İstanbul: Nobel Yayın Dağıtım; 2022:263-287. Dağyar K. Oral Mukoza Hastalıklarının Tedavisinde Kortikosteroid Kullanımı. Bitirme Tezi. İstanbul Üniversitesi Diş Hekimliği Fakültesi; 2021.
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
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- YKU-PEG-ORALCARE-2026-01
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
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
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米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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