Clinical trial NCT04883944: Maternal Involvement in Pain Management in NICU
Official title: Maternal Involvement in Pain Management in NICU: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Mother-Infant Interaction
Infant, Newborn
Stress, Physiological
Keywords: NICU, newborn, pain, Parental stress, nurse
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2021-05-12
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: a prospective, randomized controlled trial with a 2x2 crossover design
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Newborn's pain response during the performance of the heel stick procedure
timeFrame: From 15 seconds before heel stick to 30 seconds after the end of the procedure
Secondary outcomes:
measure: Anxiety, stress and depression of mother
timeFrame: From the date of inclusion until the date of completion study, measured up to 15 days
measure: Stress levels of nurse performing heel stick
timeFrame: From the date of inclusion until the date of completion study, measured up to 15 days
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU
state: MI
Study officials:
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Agostino Guarino, RN
role: PRINCIPAL_INVESTIGATOR
References:
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