Study Results
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Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-05-17
2022-05-16
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
\- 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
* 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
1 Week
1 Month
ALL
No
Sponsors
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Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
OTHER
Responsible Party
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Principal Investigators
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Agostino Guarino, RN
Role: PRINCIPAL_INVESTIGATOR
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Locations
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Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU
Milan, MI, Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
Other Identifiers
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Co.Ma.Do./2021
Identifier Type: -
Identifier Source: org_study_id
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