Parents as Pain Management in Swedish Neonatal Care

NCT04341194 | Completed

• 1 other identifier: LIVFOU-930025
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 4

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Changes in galvanic skin response

  Through study completion, an average of 1 year.

• 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.

Study Arms (3)

Standard care with glucose

NO INTERVENTION

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

EXPERIMENTAL

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.

Behavioral: Parent-driven pain management with skin-to-skin contact

Skin-to-skin contact/breastfeeding/parental singing

EXPERIMENTAL

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.

Behavioral: Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing

Interventions

Parent-driven pain management with skin-to-skin contact BEHAVIORAL

The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.

Skin-to-skin contact

Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing BEHAVIORAL

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.

Skin-to-skin contact/breastfeeding/parental singing

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Värmland County Council, Sweden: lead
• Region Örebro County: collaborator
• Uppsala County Council, Sweden: collaborator
• Dalarna County Council, Sweden: collaborator
• Sykehuset Telemark: collaborator
• Örebro University, Sweden: collaborator

Study Sites (4)

Neonatalavdelningen Centralsjukhuset i Karlstad

Karlstad, Värmland County, Sweden

Location

BB Falun Region Dalarna

Falun, Sweden

Location

Neonatalavdelningen, avd. 35, UniversitetssjukhusetX

Örebro, Sweden

Location

Intensivvårdsavdelningen för nyfödda, avd 95F, Akademiska barnsjukhuset

Uppsala, Sweden

Location

Related Publications (2)

• 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. doi: 10.1186/s12887-025-06393-y. Online ahead of print.

  PMID: 41366329 DERIVED

• 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.

  PMID: 33046026 DERIVED

MeSH Terms

Conditions

Agnosia; Breast Feeding

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Study Officials

• Alexandra Ullsten, PhD

  Värmland County Council, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes. which are randomly picked out before the meeting with each participant.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 10, 2020
• Study Start: March 1, 2021
• Primary Completion: September 15, 2023
• Study Completion: September 15, 2023
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (4)