Clinical trial NCT04341194: Parents as Pain Management in Swedish Neonatal Care
Official title: Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Pain Management
Parent-driven Pain Management
Keywords: Infants
parents
neonatal intensive care
pain management
skin-to-skin contact
breastfeeding
live parental lullaby singing
PKU screening
participatory action research
randomized controlled trial
Lead sponsor: Värmland County Council, Sweden
Sponsor class: OTHER_GOV
Collaborators: name: Region Örebro County
name: Uppsala County Council, Sweden
name: Dalarna County Council, Sweden
name: Sykehuset Telemark
name: Örebro University, Sweden
First posted: 2020-04-10
Enrollment: 225
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

Healthy, full term infants who will be screened with the routine PKU test and their parent.

Exclusion Criteria:

Infants treated with sedatives or analgesics within the last 24 hours.

Primary outcomes:
measure: Pain in infants
timeFrame: Through study completion, an average of 1 year.
Secondary outcomes:
measure: Changes in galvanic skin response
timeFrame: Through study completion, an average of 1 year.
measure: Parental rating of the infant's pain
timeFrame: Through study completion, an average of 1 year.
measure: Change in heart rate
timeFrame: Through study completion, an average of 1 year.
measure: Change in transcutaneous oxygen saturation
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
city: Karlstad
country: Sweden
facility: Neonatalavdelningen Centralsjukhuset i Karlstad
state: Värmland
city: Falun
country: Sweden
facility: BB Falun Region Dalarna
city: Uppsala
country: Sweden
facility: Intensivvårdsavdelningen för nyfödda, avd 95F, Akademiska barnsjukhuset
city: Örebro
country: Sweden
facility: Neonatalavdelningen, avd. 35, UniversitetssjukhusetX
Study officials:
affiliation: Värmland County Council, Sweden
name: Alexandra Ullsten, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olsson E, Carlsen Misic M, Dovland Andersen R, Ericson J, Eriksson M, Thernstrom Blomqvist Y, Ullsten A. Study protocol: parents as pain management in Swedish neonatal care - SWEpap, a multi-center randomized controlled trial. BMC Pediatr. 2020 Oct 12;20(1):474. doi: 10.1186/s12887-020-02356-7.