Effect of Nesting During Intramuscular Injection on Pain, Stress, and Breastfeeding Success in Cesarean-Born Term Newborns (NESTING)
The Effect of Nesting Practice on Pain, Stress Level, and Breastfeeding Success During Intramuscular Injection in Term Newborns Delivered by Cesarean Section
調査の概要
詳細な説明
Painful procedures performed during the first hours after birth, particularly intramuscular vitamin K and hepatitis B injections, are associated with significant pain and stress responses in newborns. Although several non-pharmacological interventions have been recommended to minimize procedural pain, evidence regarding the effectiveness of nesting in healthy term newborns delivered by cesarean section remains limited.
This study is designed as a prospective, single-center, parallel-group, randomized controlled trial. The study will be conducted in the newborn observation room of the Delivery Unit at Kocaeli Darıca Farabi Training and Research Hospital. Healthy term newborns (37-42 weeks of gestation) delivered by cesarean section will be enrolled after written informed parental consent is obtained. A total of 112 newborns will be randomly allocated in a 1:1 ratio to either the nesting intervention group or the routine care control group using Random Allocation Software.
Newborns assigned to the intervention group will be placed in a sterile cotton nesting position until the first intramuscular injection. Routine intramuscular administration of vitamin K and hepatitis B vaccine will be performed according to standard neonatal care. The control group will receive routine neonatal care without nesting. No additional invasive procedures will be performed for research purposes.
Pain, stress level, heart rate, respiratory rate, oxygen saturation, and settling time will be assessed before, during, and one minute after the injection. Breastfeeding success will be evaluated at the first breastfeeding after mother-infant reunion, at one hour after breastfeeding, and before hospital discharge using validated assessment tools. Outcome assessment will be performed by an independent assessor who is blinded to group allocation.
The primary objective of this study is to determine whether nesting reduces procedural pain and stress while improving physiological stability and breastfeeding success in term newborns delivered by cesarean section. The results are expected to contribute to evidence-based neonatal care by supporting the implementation of developmental, non-pharmacological interventions during routine newborn procedures.
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：Emine Nur Çalımlı Celep, Msc
- 電話番号：+90 506 126 48 03
- メール：enurcalimli@gmail.com
研究連絡先のバックアップ
- 名前：Yasemin Dinçel, MSc
- 電話番号：+90 545 939 49 26
- メール：yasemindincel96@gmail.com
研究場所
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Kocaeli
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Darıca、Kocaeli、トルコ（Türkiye）
- 募集
- Kocaeli Darıca Farabi Training and Research Hospital
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コンタクト：
- Emine Nur Çalımlı Celep, Msc
- 電話番号：+90 506 126 48 03
- メール：enurcalimli@gmail.com
-
主任研究者：
- Sevil İnal, Prof. Dr.
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副調査官：
- Emine Nur Çalımlı Celep, Msc
-
副調査官：
- Yasemin Dinçel, Msc
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-
参加基準
適格基準
就学可能な年齢
- 子
健康ボランティアの受け入れ
説明
Inclusion Criteria:
- Written informed consent was obtained from the parent(s) or legal guardian(s) of the newborn.
- Born by cesarean section.
- Term newborn (gestational age between 37+0 and 41+6 weeks).
- Birth weight between 2,500 g and 4,000 g.
- Clinically stable vital signs (including heart rate, respiratory rate, and oxygen saturation).
- No acute or chronic medical conditions.
- No congenital anomalies.
- No requirement for endotracheal intubation, resuscitation, or admission to the neonatal intensive care unit (NICU).
- Scheduled to receive the first intramuscular injection after birth.
Exclusion Criteria:
- Multiple birth (e.g., twins or higher-order multiples).
- Administration of vitamin K or hepatitis B vaccine before completion of the study procedures.
- Withdrawal of parental consent at any time during the study.
- Use of a pacifier, oral sucrose, or any pharmacological or non-pharmacological pain-relief intervention before completion of the outcome assessments.
- Discharge from the hospital or transfer to another healthcare facility before completion of the study procedures.
- Delayed mother-newborn reunion due to maternal general anesthesia or prolonged sedation following spinal or epidural anesthesia.
- Delayed transfer of the newborn to the mother because of prolonged surgery, intraoperative complications, or delayed postoperative stabilization.
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：Nesting Group
Term newborns delivered by cesarean section will receive the nesting intervention before and during routine intramuscular injection.
Pain, stress level, and breastfeeding success will be assessed using validated outcome measures.
|
Nesting is a non-pharmacological positioning intervention in which the newborn is placed in a flexed, midline posture using rolled towels or positioning supports to provide containment before and during intramuscular injection.
The intervention aims to reduce procedural pain and stress and improve breastfeeding success.
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|
介入なし：Standard Care Group
Term newborns delivered by cesarean section will receive routine care during intramuscular injection without the nesting intervention.
Pain, stress level, and breastfeeding success will be assessed using the same outcome measures.
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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 |
|---|---|---|
|
Neonatal Pain
時間枠：Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS).
The pain/agitation component consists of five behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 10. Higher scores indicate greater pain.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Neonatal Stress Level
時間枠：Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Neonatal stress will be assessed using the Neonatal Stress Scale.
The scale consists of eight behavioral and physiological indicators, each scored from 0 to 2, yielding a total score ranging from 0 to 16.
Higher scores indicate greater neonatal stress.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Heart Rate
時間枠：Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Heart rate will be measured in beats per minute (bpm) to evaluate the newborn's physiological response to intramuscular injection.
Higher heart rate values indicate a greater physiological response to procedural stress.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Respiratory Rate
時間枠：Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Respiratory rate will be measured in breaths per minute (breaths/min) to evaluate the newborn's physiological response to intramuscular injection.
Higher respiratory rate values indicate a greater physiological response to procedural stress.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Peripheral Oxygen Saturation
時間枠：Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Peripheral oxygen saturation (SpO₂) will be measured using pulse oximetry and reported as a percentage (%) to evaluate the newborn's physiological response to intramuscular injection.
Higher SpO₂ values indicate better oxygenation.
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Immediately before intramuscular injection, during intramuscular injection, and 1 minute after intramuscular injection.
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Breastfeeding Success
時間枠：At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
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Breastfeeding success will be assessed using the Bristol Breastfeeding Assessment Tool (BBAT).
The BBAT consists of four items (positioning, attachment, sucking, and swallowing), each scored from 0 to 2. Total scores range from 0 to 8, with higher scores indicating better breastfeeding effectiveness.
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At the first breastfeeding following mother-newborn reunion, 1 hour after the first breastfeeding, and 48 hours after birth (prior to hospital discharge).
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協力者と研究者
捜査官
- 主任研究者：Sevil İnal, Prof. Dr.、Istanbul University-Cerrahpasa, Department of Midwifery
研究記録日
主要日程の研究
研究開始 (実際)
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
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