Maternal Involvement in Pain Management in NICU
Condition: Procedural Pain; Mother-Infant Interaction; Infant, Newborn; Stress, Physiological
MeSH terms: Pain, Procedural
Study type: Interventional

Summary: 
      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: 
      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.
    

Intervention name(s): Intervention group; Standard care group
Intervention type(s): Other; Other
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: a prospective, randomized controlled trial with a 2x2 crossover design
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: NICU, newborn, pain, Parental stress, nurse