Maternal Involvement in Pain Management in NICU

NCT04883944 | Completed DMC

• 1 other identifier: Co.Ma.Do./2021
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NICU, newborn, pain, Parental stress, nurse

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety, stress and depression of mother

  From the date of inclusion until the date of completion study, measured up to 15 days

• Stress levels of nurse performing heel stick

  From the date of inclusion until the date of completion study, measured up to 15 days

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Standard care

ACTIVE COMPARATOR

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

Interventions

Intervention group OTHER

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.

Intervention group

Standard care group OTHER

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.

Standard care

Eligibility Criteria

• Age: 1 Week - 1 Month
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: lead

Study Sites (1)

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU

Milan, MI, 20122, Italy

Location

Related Publications (9)

• COMMITTEE ON FETUS AND NEWBORN and SECTION ON ANESTHESIOLOGY AND PAIN MEDICINE. Prevention and Management of Procedural Pain in the Neonate: An Update. Pediatrics. 2016 Feb;137(2):e20154271. doi: 10.1542/peds.2015-4271. Epub 2016 Jan 25.

  PMID: 26810788 BACKGROUND

• Axelin A, Lehtonen L, Pelander T, Salantera S. Mothers' different styles of involvement in preterm infant pain care. J Obstet Gynecol Neonatal Nurs. 2010 Jul-Aug;39(4):415-24. doi: 10.1111/j.1552-6909.2010.01150.x.

  PMID: 20629928 BACKGROUND

• Bellieni CV, Buonocore G, Nenci A, Franci N, Cordelli DM, Bagnoli F. Sensorial saturation: an effective analgesic tool for heel-prick in preterm infants: a prospective randomized trial. Biol Neonate. 2001 Jul;80(1):15-8. doi: 10.1159/000047113.

  PMID: 11474143 BACKGROUND

• Bottesi G, Ghisi M, Altoe G, Conforti E, Melli G, Sica C. The Italian version of the Depression Anxiety Stress Scales-21: Factor structure and psychometric properties on community and clinical samples. Compr Psychiatry. 2015 Jul;60:170-81. doi: 10.1016/j.comppsych.2015.04.005. Epub 2015 Apr 15.

  PMID: 25933937 BACKGROUND

• Busse M, Stromgren K, Thorngate L, Thomas KA. Parents' responses to stress in the neonatal intensive care unit. Crit Care Nurse. 2013 Aug;33(4):52-9; quiz 60. doi: 10.4037/ccn2013715.

  PMID: 23908169 BACKGROUND

• Cruz MD, Fernandes AM, Oliveira CR. Epidemiology of painful procedures performed in neonates: A systematic review of observational studies. Eur J Pain. 2016 Apr;20(4):489-98. doi: 10.1002/ejp.757. Epub 2015 Jul 29.

  PMID: 26223408 BACKGROUND

• Lago P, Garetti E, Merazzi D, Pieragostini L, Ancora G, Pirelli A, Bellieni CV; Pain Study Group of the Italian Society of Neonatology. Guidelines for procedural pain in the newborn. Acta Paediatr. 2009 Jun;98(6):932-9. doi: 10.1111/j.1651-2227.2009.01291.x.

  PMID: 19484828 BACKGROUND

• Lovibond PF, Lovibond SH. The structure of negative emotional states: comparison of the Depression Anxiety Stress Scales (DASS) with the Beck Depression and Anxiety Inventories. Behav Res Ther. 1995 Mar;33(3):335-43. doi: 10.1016/0005-7967(94)00075-u.

  PMID: 7726811 BACKGROUND

• Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.

  PMID: 8506163 BACKGROUND

MeSH Terms

Conditions

Pain, Procedural; Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Agostino Guarino, RN

  Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a prospective, randomized controlled trial with a 2x2 crossover design

Study Record Dates

• First Submitted: May 7, 2021
• First Posted: May 12, 2021
• Study Start: May 17, 2021
• Primary Completion: May 16, 2022
• Study Completion: May 16, 2022
• Last Updated: May 23, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)