Loading search results
Sponsor study identifier
interventional
225
1 country
4
Study Start
March 1, 2021
Actual (reported)Primary Completion
September 15, 2023
Actual (reported)Study Completion
September 15, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 15, 2023
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 6, 2020
Actual (reported)April 10, 2020
Actual (reported)March 1, 2021
Actual (reported)September 15, 2023
Actual (reported)September 15, 2023
Actual (reported)Pain in infants
The primary outcome in the randomized controlled trial is pain in infants measured with the Premature Infant Pain Profile Revised (PIPP-R). The PIPP-R evaluates three behavioral facial actions (brow bulge, eye squeeze and nasolabial furrow), two physiological items (heart rate, transcutaneous oxygen saturation), and two contextual items (gestational age and behavioral state). The PIPP is weighted for younger gestational age and sleep state. Scores can range from 0 to 21, and a difference of two points between conditions can be considered clinically important.
Through study completion, an average of 1 year.
Changes in galvanic skin response
Through study completion, an average of 1 year.
Control Group with standard care comprises facilitated tucking done by a nurse or the parent, oral glucose (300 mg/ml) and the opportunity to suck on a pacifier or on a parent's or a nurse's plastic gloved finger. The infant is placed on an examination table for the venipuncture.
Skin-to-skin contact is a method widely used in neonatal care globally. The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.
Parent-driven interventions are skin-to-skin care, breastfeeding and multi-sensory stimulation like vocalisation. They are all a combination of multiple sensory inputs comprising auditory, tactile and olfactory recognition. Research has started to investigate breastfeeding in combination with Kangaroo-mother- care for example, which has shown to be an effective mix. A multimodal approach that includes a combination of non-pharmacological approaches is considered more effective during venipuncture than single strategies and provides greater pain relief.
The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.
Live parental infant-directed lullaby singing is an individually tailored, non-verbal, multisensory, multimodal and affective tool to regulate the infant before, during and after venipuncture. Direct breast-feeding has demonstrated efficacy that is equal to, or greater than, sweet taste interventions in reducing behavioral and physiological responses to pain in full-term infants undergoing venipuncture with no demonstrated adverse outcomes. Direct breast-feeding should be considered the preferred first-line analgesic intervention for painful procedures performed on full-term infants.
Neonatalavdelningen Centralsjukhuset i Karlstad
Karlstad, Värmland County, Sweden
BB Falun Region Dalarna
Falun, Sweden
Neonatalavdelningen, avd. 35, UniversitetssjukhusetX
Örebro, Sweden
Intensivvårdsavdelningen för nyfödda, avd 95F, Akademiska barnsjukhuset
Uppsala, Sweden
Misic MC, Ericson J, Eriksson M, Olsson E, Ullsten A. Effect of combined skin-to-skin contact, breastfeeding, and parents' live lullaby singing on relieving acute procedural pain in neonates (SWEpap): a multicenter randomized controlled trial in Sweden. BMC Pediatr. 2025 Dec 10;26(1):37. doi: 10.1186/s12887-025-06393-y.
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.
Alexandra Ullsten, PhD
Värmland County Council, Sweden
225 participants (actual enrollment reported by the registry).
First Submitted
April 6, 2020
First Posted
April 10, 2020
Study Start
March 1, 2021
Actual (reported)Parental rating of the infant's pain
Through study completion, an average of 1 year.
Change in heart rate
Through study completion, an average of 1 year.
Change in transcutaneous oxygen saturation
Through study completion, an average of 1 year.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
September 15, 2023
Actual (reported)Study Completion
September 15, 2023
Actual (reported)Last Updated
October 26, 2023
Record last verified: 2023-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: