Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-30 @ 11:21 AM
Study NCT ID:
NCT04341194
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2020-04-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Parents as Pain Management in Swedish Neonatal Care
Sponsor:
Värmland County Council, Sweden
Organization:
Study Overview
Official Title:
Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Parents are a valuable but underused resource in neonatal pain management. In the Nordic countries, family-centred neonatal care has come a long way in welcoming and including parents in the everyday care of their infant. Nonseparation of parents and infants is a protective measure in decreasing stress in both parents and infants and should also be applicable during painful procedures. Sick newborn infants and infants that are born premature are cared for in neonatal intensive care units (NICUs). Because of the intense nature of the care the infants are subjected to an extensive amount of painful procedures and treatments needed for survival. Research shows that infants cared for in the NICU, experience on average between 7 and 17 painful procedures per day, and far from all infants receive adequate pharmacological or non-pharmacological analgesia during the procedures. The parents' role in the pain experience of older children has received considerable attention in research, but parents' participation in infant pain management has quite recently become a focus for research in nursing pain science with currently a handful studies. Research shows for example that when parents are present, the documentation of nursing pain assessment increases as well as the use of non-pharmacological pain-relieving methods, and parental presence can reduce the child's pain intensity and behavioural distress. There is no previous research within Swedish health care context that has investigated the parents' attitudes towards being involved in their infant's pain management, nor any research that previously has assessed the efficacy of combined parent-driven pain management such as skin-to-skin contact or breastfeeding including parental live lullaby singing. The objectives for the study are to investigate parents' and health professional's attitudes, experiences and perspectives on non-pharmacological parent-driven pain management and also to test the efficacy of combined parent-driven pain management such as skin-to-skin contact, breastfeeding and parental live lullaby singing.
Detailed Description:
Study design and eligibility criteria:
The study design for the qualitative part of this study, tier one, is inspired by Participatory Action Research (PAR), involving both parents and health professionals in neonatal intensive care in a collaborative research project. Our ambition with the PAR design is to democratize the research process and include also the parents in the knowledge making. One focus group per region is recruited by the researchers and the participants are recruited based on their interest for parent-driven pain management. The focus groups contain two parents of infants who currently are admitted to the NICU, one parent who previously experienced NICU care, two health professionals and two researchers. In the focus groups, the NICU parents, the health professionals and the researchers will sit together discussing and sharing knowledge about parent-driven pain management interventions. The parents in the groups will then test the parent-driven interventions during a routine blood sample.The feedback from the focus groups will purportedly bring about guidelines for parent-driven pain management which are context sensitive and tailored to the Swedish family-centered NICU situation and public health care system as well as bring forth information how to implement parent-driven methods.
The second tier of the study is a randomized controlled trial. A written informed consent is acquired from each and one of the infant's parents. Healthy, full term infants who will be screened with the routine phenylketonuria (PKU) test and their parent, are enrolled and randomized into one of three groups; one control group with glucose (n= 75), one group with skin-to-skin contact (n= 75), and one group where the skin-to-skin contact is combined with breastfeeding and live parental lullaby singing (n= 75). All infants will receive effective pain management of some kind. Infants treated with sedatives or analgesics within the last 24 hours are excluded.
The study design for the qualitative part of this study, tier one, is inspired by Participatory Action Research (PAR), involving both parents and health professionals in neonatal intensive care in a collaborative research project. Our ambition with the PAR design is to democratize the research process and include also the parents in the knowledge making. One focus group per region is recruited by the researchers and the participants are recruited based on their interest for parent-driven pain management. The focus groups contain two parents of infants who currently are admitted to the NICU, one parent who previously experienced NICU care, two health professionals and two researchers. In the focus groups, the NICU parents, the health professionals and the researchers will sit together discussing and sharing knowledge about parent-driven pain management interventions. The parents in the groups will then test the parent-driven interventions during a routine blood sample.The feedback from the focus groups will purportedly bring about guidelines for parent-driven pain management which are context sensitive and tailored to the Swedish family-centered NICU situation and public health care system as well as bring forth information how to implement parent-driven methods.
The second tier of the study is a randomized controlled trial. A written informed consent is acquired from each and one of the infant's parents. Healthy, full term infants who will be screened with the routine phenylketonuria (PKU) test and their parent, are enrolled and randomized into one of three groups; one control group with glucose (n= 75), one group with skin-to-skin contact (n= 75), and one group where the skin-to-skin contact is combined with breastfeeding and live parental lullaby singing (n= 75). All infants will receive effective pain management of some kind. Infants treated with sedatives or analgesics within the last 24 hours are excluded.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: