- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04341194
Parents as Pain Management in Swedish Neonatal Care
Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Falun, Sweden
- BB Falun Region Dalarna
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Uppsala, Sweden
- Intensivvårdsavdelningen för nyfödda, avd 95F, Akademiska barnsjukhuset
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Örebro, Sweden
- Neonatalavdelningen, avd. 35, UniversitetssjukhusetX
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Värmland
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Karlstad, Värmland, Sweden
- Neonatalavdelningen Centralsjukhuset i Karlstad
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: Standard care with glucose
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.
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Experimental: Skin-to-skin contact
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.
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The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.
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Experimental: Skin-to-skin contact/breastfeeding/parental singing
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Pain in infants
Time Frame: Through study completion, an average of 1 year.
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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.
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Through study completion, an average of 1 year.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in galvanic skin response
Time Frame: Through study completion, an average of 1 year.
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Changes in galvanic skin response (GSR), which is obtained via three electrodes on the infant's foot.
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Through study completion, an average of 1 year.
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Parental rating of the infant's pain
Time Frame: Through study completion, an average of 1 year.
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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).
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Through study completion, an average of 1 year.
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Change in heart rate
Time Frame: Through study completion, an average of 1 year.
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For measuring heart rate variability.
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Through study completion, an average of 1 year.
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Change in transcutaneous oxygen saturation
Time Frame: Through study completion, an average of 1 year.
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Changes in transcutaneous oxygen saturation, which is obtained via an electrode on the infant's foot.
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Through study completion, an average of 1 year.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Alexandra Ullsten, PhD, Värmland County Council, Sweden
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- LIVFOU-930025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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