Effect of Multisensory Stimulation on Pain During Heel Lance in Newborns
The Effect of Multisensory Stimulation Applied During Heel Blood Sampling on Pain and Physiological Parameters in Newborns: A Randomized Controlled Trial
調査の概要
詳細な説明
Heel blood sampling is a routine procedure used in newborn screening; however, it can produce pain, crying, and short-term changes in physiological parameters such as heart rate and oxygen saturation. Non-pharmacological approaches are commonly used to reduce procedural pain in newborns, but the effects of individual methods may be inconsistent. Multisensory stimulation combines several familiar and comforting sensory inputs and may reduce pain by directing attention away from the procedure, supporting autonomic regulation, and decreasing the stress response.
In this study, multisensory stimulation will consist of breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn. Breastfeeding and gentle stroking will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure. Maternal singing and eye contact will be maintained throughout the procedure. The control condition will reflect supportive routine care, with the newborn held in the mother's arms during heel blood sampling.
The study will examine whether this structured multisensory approach reduces procedural pain and crying and supports physiological stability in healthy newborns. Pain, heart rate, and oxygen saturation will be assessed before, during, and after heel blood sampling. Crying duration and total procedure duration will also be recorded. The findings may contribute to the development of a safe, practical, and standardized non-pharmacological approach to pain management 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：İlçim Ercan-Koyuncu, PhD
- 電話番号：+905534700629
- メール：ilcimercan@hotmail.com
研究場所
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Beşevler
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Ankara、Beşevler、トルコ（Türkiye）、60300
- 募集
- Tatvan State Hospital
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コンタクト：
- İlçim Ercan-Koyuncu
- 電話番号：05534700629
- メール：ilcimercan@hotmail.com
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Bitlis
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Bitlis、Bitlis、トルコ（Türkiye）、60300
- 募集
- Bitlis State Hospita
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コンタクト：
- İlçim Ercan-Koyuncu
- 電話番号：05534700629
- メール：ilcimercan@hotmail.com
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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:
- Healthy newborns aged 0-28 days
- Newborns receiving routine monitoring and care with their mothers in the hospital's newborn care unit
- Written informed consent provided by the newborn's parent or legal representative
Exclusion Criteria:
- Presence of any lower-extremity anomaly
- Ongoing monitoring or treatment in the neonatal intensive care unit
- Presence of a congenital disease
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：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 |
|---|---|
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実験的：Multisensory Stimulation Group
Newborns assigned to this arm will receive a structured multisensory stimulation intervention during heel blood sampling.
The intervention will include breastfeeding, gentle stroking of the leg, maternal singing or lullaby, and continuous eye contact between the mother and newborn.
Breastfeeding and gentle stroking will begin 10 minutes before the procedure and continue until 5 minutes after the procedure.
Maternal singing and eye contact will be maintained throughout heel blood sampling.
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The multisensory stimulation intervention consists of four components: breastfeeding, gentle stroking, maternal singing or lullaby, and eye contact.
Breastfeeding will begin 10 minutes before heel blood sampling and continue until 5 minutes after the procedure.
During the same 15-minute period, the mother will gently stroke the newborn's leg from which the heel blood sample will be obtained.
Throughout the heel blood sampling procedure, the mother will sing a lullaby or song in a soft and calm voice and maintain continuous eye contact with the newborn.
No standardized song or lullaby will be prescribed, and the sound level will remain within the range of natural mother-newborn communication.
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介入なし：Mother's Arms Control Group
Newborns assigned to this arm will receive routine heel blood sampling while being held in their mother's arms.
No additional structured non-pharmacological pain-reduction intervention will be administered.
When necessary, the mother may gently hold and support the newborn in a comfortable position during the procedure.
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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 |
|---|---|---|
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N-PASS Pain Score
時間枠：Immediately before, during, and immediately after heel blood sampling.
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Newborn pain will be assessed using the Neonatal Pain, Agitation and Sedation Scale (N-PASS).
The scale evaluates crying or irritability, behavioral state, facial expression, extremity tone or body tension, and changes in vital signs.
Higher pain scores indicate greater pain or agitation.
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Immediately before, during, and immediately after heel blood sampling.
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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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Crying Duration
時間枠：During the heel blood sampling session.
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The total duration of crying associated with heel blood sampling will be measured using a stopwatch and recorded in seconds.
A shorter crying duration indicates a more favorable outcome.
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During the heel blood sampling session.
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Heart Rate
時間枠：Immediately before, during, and immediately after heel blood sampling.
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Heart rate will be measured non-invasively using a bedside pulse oximeter and recorded as beats per minute.
Heart rate values will be assessed to determine physiological responses to heel blood sampling and the multisensory stimulation intervention.
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Immediately before, during, and immediately after heel blood sampling.
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Oxygen Saturation
時間枠：Immediately before, during, and immediately after heel blood sampling.
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Peripheral oxygen saturation will be measured non-invasively using a bedside pulse oximeter and recorded as a percentage.
Higher and more stable oxygen saturation values indicate a more favorable physiological response.
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Immediately before, during, and immediately after heel blood sampling.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Procedure Duration
時間枠：During a single heel blood sampling procedure
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The total duration of the heel blood sampling procedure will be measured using a stopwatch and recorded in seconds.
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During a single heel blood sampling procedure
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Garcia-Valdivieso I, Yanez-Araque B, Moncunill-Martinez E, Bocos-Reglero MJ, Gomez-Cantarino S. Effect of Non-Pharmacological Methods in the Reduction of Neonatal Pain: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2023 Feb 12;20(4):3226. doi: 10.3390/ijerph20043226.
- Jin L, Zhang J, Yang X, Rong H. Maternal voice reduces procedural pain in neonates: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2023 Mar 24;102(12):e33060. doi: 10.1097/MD.0000000000033060.
- Sahin K, Yildiz S, Gur E. The effect of multi-sensory stimuli used during vaccination on pain and physiological parameters in infants: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:20-30. doi: 10.1016/j.pedn.2025.11.051. Epub 2026 Jan 6.
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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