MOTHER3SENSE Study (MOTHER3SENSE)
Effects of Maternal Voice, Touch, and Scent on Pain and Stress in Newborns: A Comparison of Three Sensory Interventions
調査の概要
詳細な説明
Painful procedures are frequently performed in newborns during routine clinical care and may lead to physiological and behavioral stress responses. Non-pharmacological interventions are recommended as safe and effective approaches for reducing procedural pain and stress in newborns. Maternal sensory stimuli, including maternal voice, touch, and scent, may provide comfort and support neonatal regulation during painful procedures.
This randomized controlled trial aims to compare the effects of maternal voice, maternal touch, and maternal scent on pain and stress responses in newborns undergoing a routine heel lance procedure. Eligible newborns will be randomly assigned to one of four groups: maternal voice, maternal touch, maternal scent, or control.
The assigned intervention will be applied according to a standardized protocol before, during, and after the heel lance procedure. Pain and stress responses will be assessed at three time points: before the procedure, during the procedure, and after the procedure. Behavioral and physiological indicators will be used to evaluate neonatal pain and stress responses.
The primary objective of the study is to determine and compare the effectiveness of maternal voice, touch, and scent in reducing procedural pain and stress in newborns. The findings may contribute to evidence-based, family-centered, and non-pharmacological pain management practices in neonatal care.
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：Elif Simay KOÇ, Lecturer
- 電話番号：+90 348 813 93 01
- メール：kocelifsimay@gmail.com
研究場所
-
-
-
Kilis、トルコ（Türkiye）、79000
- Kilis Alaeddin Yavaşça State Hospital
-
コンタクト：
- Elif Simay KOÇ
- 電話番号：+90 348 813 93 01
- メール：kocelifsimay@gmail.com
-
-
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:
- Term newborns born between 37 and 42 weeks of gestation
- Newborns without respiratory, cardiac, metabolic, neurological, or infectious diseases
- Newborns not requiring oxygen therapy, phototherapy, or intravenous treatment
- Newborns scheduled to undergo a routine heel lance procedure (metabolic screening or blood sampling)
- Mothers willing to participate in the study
- Written informed consent provided by the parent or legal guardian
- Normal vital signs before the procedure (heart rate, respiratory rate, and oxygen saturation within normal limits)
Exclusion Criteria:
- Preterm (<37 weeks) or post-term (>42 weeks) newborns
- Presence of congenital anomalies or neurological disorders
- Requirement for oxygen therapy, phototherapy, or intravenous treatment
- Respiratory, cardiac, metabolic, neurological, or infectious disease
- Abnormal vital signs before the procedure
- Parent or legal guardian refusal to provide informed consent
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：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Maternal Voice
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
|
The recorded maternal voice will be presented to the newborn before, during, and after the procedure.
|
|
実験的：Maternal Touch
The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
|
The mother will maintain contact with the newborn's palms before, during, and after the procedure to stimulate the grasp reflex and provide tactile sensory input.
|
|
実験的：Maternal Scent
The newborn will be exposed to maternal breast milk scent during the procedure.
|
The newborn will be exposed to maternal breast milk scent during the procedure.
|
|
介入なし：Control
Routine heel lance procedures will be performed, and no sensory intervention will be provided.
|
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 Infant Pain Scale
時間枠：Before the procedure, during the procedure, and immediately after the procedure
|
The Neonatal Infant Pain Scale (NIPS), originally developed by Lawrence et al. (1993), was adapted into Turkish by Akdovan (Akdovan & Yıldırım, 1999).
NIPS is used to assess procedure-related pain in newborn infants.
The scale evaluates five behavioral indicators-facial expression, crying, arm movements, leg movements, and state of arousal-as well as one physiological parameter, breathing pattern.
Pain is assessed based on the evaluation of these behavioral and physiological responses.
|
Before the procedure, during the procedure, and immediately after the procedure
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Newborn stress scale
時間枠：Before the procedure, during the procedure, and immediately after the procedure
|
The Newborn Stress Scale (NSS), developed by Ceylan and Bolışık, consists of 24 items rated on a 3-point Likert scale.
|
Before the procedure, during the procedure, and immediately after the procedure
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Newborn and Maternal Characteristics Form
時間枠：At baseline
|
This researcher-developed form, based on the literature, was used to systematically collect demographic information about mothers and medical and birth-related characteristics of newborns.
|
At baseline
|
|
Neonatal Physiological Parameters Monitoring Form
時間枠：Before the procedure, during the procedure, and immediately after the procedure
|
The Newborn Physiological Parameters Assessment Form was developed by the researchers based on the literature and was used to evaluate physiological parameters, including heart rate, oxygen saturation, and body temperature, before, during, and after the heel lance procedure.
|
Before the procedure, during the procedure, and immediately after the procedure
|
協力者と研究者
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
その他の研究ID番号
- Kilis 7 Aralık Universty
- MOTHER3SENSE Study (その他の識別子：Kilis 7 Aralık Universty)
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?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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。