Maternal Involvement in Pain Management in NICU

NCT04883944 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-05-23

No results posted yet for this study

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.

Conditions

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

Interventions

OTHER

Intervention group

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.

OTHER

Standard care group

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.

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Agostino Guarino, RN · Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
1 Week
Max Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-17
Primary Completion
2022-05-16
Completion
2022-05-16

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04883944 on ClinicalTrials.gov