Maternal Involvement in Pain Management in NICU

Study Overview
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Brief Summary
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Infants admitted to Neonatal Intensive Care Unit (NICU) may experience a negative impact due to multiple painful and stressful procedures during their hospitalization. The American Academy of Pediatrics recommends that healthcare facilities taking care of newborns should implement pain prevention and management programs. There are some non-pharmacological techniques that have been developed to reduce newborn's pain perception, including swaddling, holding, non-nutritive sucking in infants with Post-menstrual age (PMA) below 32 weeks, nutritional sucking with the administration of breast milk or sweeteners above 32 weeks PMA and exposure to maternal voice. Even for parents, the experience of NICU hospitalization of their child is a particularly stressful event, mainly characterized by feelings of exclusion due to lack of interactions with their own baby due to their clinical conditions. Hence, it is very important to intervene as soon as possible on parental stress that can affect the physical and psychological quality of life of the family. This is possible through the application of nursing care plans that involve the parents in daily care and support them in the long process of development and acquisition of autonomy and skills. The nurse is a healthcare provider who has the most frequent contact with newborns hospitalized in NICU and has a key role in preventing, recognizing, and managing newborn's pain. However, there is a considerable discrepancy between the theory and practice: many nurses and doctors are aware that most of the procedures carried out in NICU cause pain. Therefore, nurses also can develop high levels of physical and psychological stress, particularly when they manage a newborn who feels pain. The purpose of this study is to evaluate if maternal involvement in the pain management of newborn admitted to NICU may reduce the level of pain perceived by infant during the heel stick procedure using the Premature Infant Pain Profile (PIPP) pain scoring tool. In addition, the study's secondary goal will be to investigate if maternal involvement in pain management of newborn may produce positive effects on the mother in reducing stress, depression and anxiety and in reducing nurses' physical and psychological stress.

Detailed Description
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This study is a prospective, randomized controlled trial with a 2x2 crossover design. Study population include newborns admitted to NICU that require a heel stick procedure after the first week of life, mothers of enrolled infants and nurses performing the heel stick procedure. The sample size will be 50 newborns who meet the inclusion criteria. Newborns will be randomly assigned to receive: i) a heel stick procedure with maternal involvement and after a week an heel stick procedure without maternal involvement or ii) a procedure without maternal involvement and after a week a procedure with maternal involvement. For both group the washout period between the two procedures is 7 days. Before the intervention with the maternal involvement, mother will receive a training regarding the heel stick procedure and pain management. Research hypothesis: H1. Newborns receiving the intervention with the maternal involvement during the heel stick procedure have lower pain level than those who receive the intervention without the maternal involvement. H2. Mothers who are involved in their baby pain management during the heel stick procedure have lower level of stress, anxiety and depression than those who are not involved during the painful procedure. H3. Nurses have a positive effect in term of reducing stress level if mother is involved in pain management of own baby. PIPP (Premature Infant Pain Profile) scale will be used to evaluate the pain response during the heel stick procedure. The level of stress, anxiety and depression of mother and the stress level of nurse will be assessed with validated questionnaires.

Official Title
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Maternal Involvement in Pain Management in NICU: a Randomized Controlled Trial

Conditions
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Procedural Pain, Mother-Infant Interaction, Infant, Newborn, Stress, Physiological

Intervention / Treatment
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* Other: Intervention group
* Other: Standard care group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For infants: - Infants born ≥ 23 weeks of gestational age who require an heel stick procedure, after the first week of life For mothers: - Mothers' age over 18 years and good comprehension of Italian language For nurses: - Nurses or pediatric nurses with professional experience in NICU ≥ 6 months who decide to participate at the study Exclusion Criteria: For infants: Enteral and/or parenteral sedation/analgesia ongoing or suspended less than 4 hours from the beginning of the procedure Infants who receive multiple painful procedures at the same time For mothers: bad comprehension of Italian language age under 18 years For nurses: Nurses and pediatric nurses with professional experience in NICU ≤ 6 months Nurses and pediatric nurses who don't give consent to study participation

Ages Eligible for Study
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Minimum Age: 1 Week
Maximum Age: 1 Month

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: a prospective, randomized controlled trial with a 2x2 crossover design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>All the enrolled infants will receive the heel stick procedure with the maternal involvement after mother will be trained on the application of the non-pharmacological techniques during the performance of the procedure. | Other: Intervention group<br>* Mother will be involved in implementing the non-pharmacological techniques during the performance of the heel stick procedure as follow: swaddling; non-nutritive sucking with pacifier in infants with PMA < 32 weeks; nutritional sucking with sucrose and/or breast milk in infants with PMA ≥ 32 weeks; holding; exposure to maternal voice.<br>|
| Active Comparator: Standard care<br>All the enrolled infants will receive the heel stick procedure according to local protocol without the maternal involvement. The non-pharmacological techniques will be performed by a second nurse not involved in the heel stick procedure itself. | Other: Standard care group<br>* A second nurse will perform the non-pharmacological techniques during the performance of the heel stick procedure without the maternal involvement as follow: swaddling; non-nutritive sucking with pacifier in infants with PMA < 32 weeks; nutritional sucking with sucrose and/or breast milk in infants with PMA ≥ 32 weeks; holding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Newborn's pain response during the performance of the heel stick procedure | Pain score calculated with the Premature Infant Pain Profile (PIPP) pain scoring tool one time for each procedure. The scale require an observation starting 15 seconds before the heel stick to 30 seconds after the end of the procedure. This score varies from 0 (no pain) to 21 (maximun pain response). | From 15 seconds before heel stick to 30 seconds after the end of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety, stress and depression of mother | Mean scores of maternal stress of infants enrolled will be evaluated with the Parental Stressor Scale - NICU and Depression, Anxiety and Stress Scale, measured at the beginning of the study and after having performed each heel stick procedure, in both arms of study. | From the date of inclusion until the date of completion study, measured up to 15 days | 
| Stress levels of nurse performing heel stick | Mean score of stress level of nurse who performs the heel stick will be evaluated with the Rapid stress assessment scale (an Italian validated scale), measured at the beginning of the study and after having performed each heel stick procedure, in both arms of study. | From the date of inclusion until the date of completion study, measured up to 15 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NICU, newborn, pain, Parental stress, nurse