Parents as Pain Management in Swedish Neonatal Care
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|ClinicalTrials.gov Identifier: NCT04341194|
Recruitment Status : Not yet recruiting
First Posted : April 10, 2020
Last Update Posted : July 29, 2020
|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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||225 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Opaque sealed envelopes. which are randomly picked out before the meeting with each participant.|
|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|
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.
- 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.
- 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.
- 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).
- Change in heart rate [ Time Frame: Through study completion, an average of 1 year. ]For measuring heart rate variability.
- 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.
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
|Contact: Alexandra Ullsten, PhDfirstname.lastname@example.org|
|Contact: Mats H Eriksson, Professor||+46 19 303362||Mats.h.Eriksson@oru.se|
|Principal Investigator:||Alexandra Ullsten, PhD||Värmland County Council, Sweden|