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| ID | Type | Description | Link |
|---|---|---|---|
| MOTHER3SENSE Study | Other Identifier | Kilis 7 Aralık Universty |
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This randomized controlled trial aims to compare the effects of maternal voice, touch, and scent on pain and stress levels in newborns during a routine heel lance procedure. Newborns will be randomly assigned to one of three intervention groups or a control group. Pain and stress responses will be assessed using validated neonatal pain and physiological measures. The findings of this study may help identify effective, low-cost, and non-pharmacological interventions that can be used to reduce pain and stress in newborns during routine clinical procedures.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Maternal Voice | Experimental | The recorded maternal voice will be presented to the newborn before, during, and after the procedure. |
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| Maternal Touch | Experimental | 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. |
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| Maternal Scent | Experimental | The newborn will be exposed to maternal breast milk scent during the procedure. |
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| Control | No Intervention | Routine heel lance procedures will be performed, and no sensory intervention will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Maternal Voice | Other | The recorded maternal voice will be presented to the newborn before, during, and after the procedure. |
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| Measure | Description | Time Frame |
|---|---|---|
| Neonatal Infant Pain Scale | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Newborn stress scale | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Newborn and Maternal Characteristics Form | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elif Simay KOÇ, Lecturer | Contact | +90 348 813 93 01 | kocelifsimay@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kilis Alaeddin Yavaşça State Hospital | Kilis | 79000 | Turkey (Türkiye) |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D010146 | Pain |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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The outcome assessor responsible for evaluating pain and stress outcomes will be blinded to group allocation.
| Maternal Touch | Other | 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. |
|
| Maternal Scent | Other | The newborn will be exposed to maternal breast milk scent during 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |