Infant Pain ManagementNCT04341194
Parents as Pain Management in Swedish Neonatal Care
A study testing Parent-driven pain management with skin-to-skin contact and Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing in people with Infant Pain Management and Parent-driven Pain Management, run by Värmland County Council, Sweden at 4 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infant Pain Management, Parent-driven Pain Management
- What is being tested?
- Parent-driven pain management with skin-to-skin contact and Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 4 sitesSweden
- Study dates
- 1 Mar 2021to 15 Sep 2023
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy, full term infants who will be screened with the routine PKU test and their parent.
Who cannot join
- Infants treated with sedatives or analgesics within the last 24 hours.
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
BB Falun Region Dalarna
Falun
Neonatalavdelningen Centralsjukhuset i Karlstad
Karlstad, Värmland County
Neonatalavdelningen, avd. 35, UniversitetssjukhusetX
Örebro
Intensivvårdsavdelningen för nyfödda, avd 95F, Akademiska barnsjukhuset
Uppsala
About this study
Official title: Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
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.
Read the 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.
- Being tested
- Parent-driven pain management with skin-to-skin contact, Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing
- 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
- Medical subject headings
- Agnosia, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-driven pain management with skin-to-skin contactBehavioural
The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.
Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (4)
Changes in galvanic skin response
Changes in galvanic skin response (GSR), which is obtained via three electrodes on the infant's foot.
Measured: Through study completion, an average of 1 year.
Parental rating of the infant's pain
Visual analogue scale (VAS). The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse populations.Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity. The following cut points on the pain VAS have been recommended: no pain (0-4 mm), mild pain(5-44 mm), moderate pain (45-74 mm), and severe pain (75-100 mm).
Measured: Through study completion, an average of 1 year.
Change in heart rate
For measuring heart rate variability.
Measured: Through study completion, an average of 1 year.
Change in transcutaneous oxygen saturation
Changes in transcutaneous oxygen saturation, which is obtained via an electrode on the infant's foot.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start1 Mar 2021
- Primary completion15 Sep 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant Pain ManagementStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Värmland County Council, Sweden
- Sponsor type
- Other government
- Collaborators
- Region Örebro County, Uppsala County Council, Sweden, Dalarna County Council, Sweden, Sykehuset Telemark, Örebro University, Sweden
- Responsible party
- Principal investigator, Alexandra Ullsten, Värmland County Council, Sweden
- Investigators
- Alexandra Ullsten, PhD, Principal investigator, Värmland County Council, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341194
- Sponsor's protocol ID
- LIVFOU-930025
- Status last verified
- Oct 2023
- First submitted
- 6 Apr 2020
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41366329Olsson 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.
PubMed 33046026
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
- ClinicalTrials.gov ID
- NCT04341194
- Acronym / sponsor ID
- LIVFOU-930025
- Keywords
- Infants, parents, neonatal intensive care, pain management, skin-to-skin contact, breastfeeding, live parental lullaby singing, PKU screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Värmland County Council, SwedenOther government
- Collaborators
- Region Örebro County, Uppsala County Council, Sweden, Dalarna County Council, Sweden, Sykehuset Telemark, Örebro University, Sweden
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Apr 2020 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Parent-driven pain management with skin-to-skin contactSkin-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. |
| Skin-to-skin contact/breastfeeding/parental singing | Experimental | Behavioral: Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singingParent-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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy, full term infants who will be screened with the routine PKU test and their parent.
Key exclusion criteria (1 listed)
- Infants treated with sedatives or analgesics within the last 24 hours.
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 |
|---|---|---|
| Parent-driven pain management with skin-to-skin contactThe infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest. | Behavioural | Skin-to-skin contact |
| Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singingLive 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. | Behavioural | Skin-to-skin contact/breastfeeding/parental singing |
Primary outcome
Pain in infants
Time frame: Through study completion, an average of 1 year.
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.
4 secondary outcomes
Changes in galvanic skin response
Time frame: Through study completion, an average of 1 year.
Parental rating of the infant's pain
Time frame: Through study completion, an average of 1 year.
Change in heart rate
Time frame: Through study completion, an average of 1 year.
Change in transcutaneous oxygen saturation
Time frame: Through study completion, an average of 1 year.
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 26 Oct 2023.
- Derived from this study: PubMed 41366329Misic 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.
- Derived from this study: PubMed 33046026Olsson 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.
- 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.
Alexandra Ullsten, PhD principal investigator
Värmland County Council, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-driven pain management with skin-to-skin contact and Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing in people with Infant Pain Management and Parent-driven Pain Management, run by Värmland County Council, Sweden at 4 sites in Sweden.
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 1 inclusion and 1 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 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. 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?
Pain in infants (time frame: Through study completion, an average of 1 year.). 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 NCT04341194, which also lists 2 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 26 Oct 2023.