Procedural PainNCT04883944
Maternal Involvement in Pain Management in NICU
A study testing Intervention group in people with Procedural Pain and Mother-Infant Interaction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 week to 1 month
- Conditions the study is for
- Procedural Pain, Mother-Infant Interaction, Infant, Newborn
- What is being tested?
- Intervention group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 17 May 2021to 16 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 week to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, NICU
Milan, MI, 20122
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Intervention group, Standard care group
- Keywords
- NICU, newborn, pain, Parental stress, nurse
- Medical subject headings
- Pain, Procedural, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Standard care group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From 15 seconds before heel stick to 30 seconds after the end of the procedure
Secondary outcomes (2)
Anxiety, stress and depression of mother
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.
Measured: From the date of inclusion until the date of completion study, measured up to 15 days
Stress levels of nurse performing heel stick
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.
Measured: From the date of inclusion until the date of completion study, measured up to 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2021
- Study start17 May 2021
- Primary completion16 May 2022
- Study completion16 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Procedural PainStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- a prospective, randomized controlled trial with a 2x2 crossover design
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Agostino Guarino, RN, Principal investigator, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04883944
- Sponsor's protocol ID
- Co.Ma.Do./2021
- Status last verified
- May 2022
- First submitted
- 7 May 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26810788Axelin 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.
PubMed 20629928Bellieni 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.
PubMed 11474143Bottesi 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.
PubMed 25933937Busse 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.
PubMed 23908169Cruz 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.
PubMed 26223408Lago 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.
PubMed 19484828Lovibond 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.
PubMed 7726811Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
PubMed 8506163
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maternal Involvement in Pain Management in NICU: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04883944
- Acronym / sponsor ID
- Co.Ma.Do./2021
- Keywords
- NICU, newborn, pain, Parental stress, nurse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 16 May 2022 (actual)
- First posted
- 12 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- a prospective, randomized controlled trial with a 2x2 crossover design
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Intervention groupAll 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. |
| Standard care | Active comparator | Other: Standard care groupAll 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. |
Who may qualify
- Ages
- 1 week to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants born ≥ 23 weeks of gestational age who require an heel stick procedure, after the first week of life
- Mothers' age over 18 years and good comprehension of Italian language
- Nurses or pediatric nurses with professional experience in NICU ≥ 6 months who decide to participate at the study
Key exclusion criteria (9 listed)
- 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
- bad comprehension of Italian language
- age under 18 years
- Nurses and pediatric nurses with professional experience in NICU ≤ 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention groupMother 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 | Intervention group |
| Standard care groupA 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. | Other | Standard care |
Primary outcome
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).
2 secondary outcomes
Anxiety, stress and depression of mother
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Background: PubMed 26810788COMMITTEE 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.
- Background: PubMed 20629928Axelin 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.
- Background: PubMed 11474143Bellieni 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.
- Background: PubMed 25933937Bottesi 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.
- Background: PubMed 23908169Busse 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.
- Background: PubMed 26223408Cruz 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.
- Background: PubMed 19484828Lago 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.
- Background: PubMed 7726811Lovibond 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.
- Background: PubMed 8506163Miles MS, Funk SG, Carlson J. Parental Stressor Scale: neonatal intensive care unit. Nurs Res. 1993 May-Jun;42(3):148-52.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agostino Guarino, RN principal investigator
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Procedural Pain and Mother-Infant Interaction, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04883944, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.