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Parents as Pain Management in Swedish Neonatal Care

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04341194
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : July 29, 2020
Sponsor:
Collaborators:
Region Örebro County
Uppsala County Council, Sweden
Dalarna County Council, Sweden
Sykehuset Telemark
Örebro University, Sweden
Information provided by (Responsible Party):
Alexandra Ullsten, Värmland County Council, Sweden

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.

Condition or disease Intervention/treatment Phase
Infant Pain Management Parent-driven Pain Management Behavioral: Parent-driven pain management with skin-to-skin contact Behavioral: Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing Not Applicable

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 groups will then test the parent-driven interventions during a routine blood sample, before the groups meet again to evaluate their experiences and suggest solutions for plausible problems to improve clinical practice. 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, live parental lullaby singing and touch (n= 75). All infants will receive effective pain management of some kind. If applicable, health care interpreting service will be offered for parents not speaking Swedish. Infants treated with sedatives or analgesics within the last 24 hours are excluded.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Opaque sealed envelopes. which are randomly picked out before the meeting with each participant.
Primary Purpose: Prevention
Official Title: Parents as Pain Management in Swedish Family-centred Neonatal Care. A Mixed Methods Approach
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.
Behavioral: Parent-driven pain management with skin-to-skin contact
The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Changes in galvanic skin response [ Time Frame: Through study completion, an average of 1 year. ]
    Changes in galvanic skin response (GSR), which is obtained via three electrodes on the infant's foot.

  2. Parental rating of the infant's pain [ Time Frame: Through study completion, an average of 1 year. ]
    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).

  3. Change in heart rate [ Time Frame: Through study completion, an average of 1 year. ]
    For measuring heart rate variability.

  4. Change in transcutaneous oxygen saturation [ Time Frame: Through study completion, an average of 1 year. ]
    Changes in transcutaneous oxygen saturation, which is obtained via an electrode on the infant's foot.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04341194


Contacts
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Contact: Alexandra Ullsten, PhD +46724684439 alexandra.ullsten@regionvarmland.se
Contact: Mats H Eriksson, Professor +46 19 303362 Mats.h.Eriksson@oru.se

Sponsors and Collaborators
Värmland County Council, Sweden
Region Örebro County
Uppsala County Council, Sweden
Dalarna County Council, Sweden
Sykehuset Telemark
Örebro University, Sweden
Investigators
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Principal Investigator: Alexandra Ullsten, PhD Värmland County Council, Sweden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Alexandra Ullsten, Principal Investigator, Värmland County Council, Sweden
ClinicalTrials.gov Identifier: NCT04341194    
Other Study ID Numbers: LIVFOU-930025
First Posted: April 10, 2020    Key Record Dates
Last Update Posted: July 29, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandra Ullsten, Värmland County Council, Sweden:
Infants
parents
neonatal intensive care
pain management
skin-to-skin contact
breastfeeding
live parental lullaby singing
PKU screening
participatory action research
randomized controlled trial