Maternal Involvement in Pain Management in NICU

May 20, 2022 updated by: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MI
      • Milan, MI, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 week to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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

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.
Active Comparator: Standard care
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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Newborn's pain response during the performance of the heel stick procedure
Time Frame: From 15 seconds before heel stick to 30 seconds after the end of the 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
Time Frame: From the date of inclusion until the date of completion study, measured up to 15 days
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
Time Frame: From the date of inclusion until the date of completion study, measured up to 15 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Investigators

  • Principal Investigator: Agostino Guarino, RN, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Actual)

May 16, 2022

Study Completion (Actual)

May 16, 2022

Study Registration Dates

First Submitted

May 7, 2021

First Submitted That Met QC Criteria

May 7, 2021

First Posted (Actual)

May 12, 2021

Study Record Updates

Last Update Posted (Actual)

May 23, 2022

Last Update Submitted That Met QC Criteria

May 20, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Co.Ma.Do./2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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