Pilot-testing a Perinatal Palliative Care Intervention Program
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVrije Universiteit Brussel
About this trial
The objective of this pilot trial is to implement a new perinatal palliative care intervention program tailored to the Flemish context, which aims to provide care to parents who receive a severe foetal/neonatal diagnosis for their (unborn) child and to their healthcare providers. Additionally, we aim to evaluate the feasibility and preliminary effectiveness by comparing measured variables to the baseline measurement done in the same hospital wards beforehand.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
who receive a severe foetal diagnosis for their unborn child and decide to continue the pregnancy after 20 weeks of gestation , or
who receive a severe foetal diagnosis for their unborn child after 20 weeks gestation and decide to terminate the pregnancy (with or without feticide) resulting in the stillbirth of their child
Parents who receive a severe neonatal diagnosis for their live-born infant in the first week after birth
Parents are either Dutch speaking, or are willing to participate with support from a (phone or real life) interpreter, in collaboration with the "Agentschap Integratie & Inburgering"
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Perinatal palliative care
BehavioralIntervention group will receive specialized perinatal palliative care support from moment of severe perinatal diagnosis. This intervention is aimed at 5 major care components, namely 1. Support offered by a fixed perinatal palliative care team, 2. that team has received specialized perinatal palliative care training, 3. care is structured within a new perinatal palliative care approach or pathway, including fixed means of communication with team members, 4. psychological support is structurally being offered to parents and healthcare providers, and 5. debriefings after every perinatal death are being organized in the involved team.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Baseline groupNo intervention 0 interventions
Group B: Perinatal palliative care groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
NeoComfort scale
The validated NeoComfort scale will be used to assess pain and discomfort. The COMFORTneo scale is composed of 7 behavioral dimensions: As respiratory response applies to ventilated neonates only, and crying to spontaneously breathing neonates only (including those requiring continuous positive airway pressure), the rater will actually rate 6 dimensions. Alertness, calmness/agitation, facial tension, muscle tone, body movement are rated for all neonates. As responses are on a 1 to 5 Likert scale, total scores range from 6 to 30-with higher scores indicating more pain.scores range from 6 to 30-with higher scores indicating more pain.
Time frame
every four hours (six times per day) during care provision for neonates only2
Administered medication and procedures
All medication administration and procedures followed are registered throughout the care trajectory. Duration or timing is impossible to predict.
Time frame
during care provision3
Contact moments with healthcare providers
Contact moments between healthcare providers and parents are registered throughout the care trajectory. Duration or timing is impossible to predict.
Time frame
during care provision4
Parental Perinatal Grief Scale
Scoring of the parental Perinatal Grief Scale. The short version of the Perinatal Grief Scale consists of 33 items that represents three subscales each consisting of 11 items: active grief (sadness, missing the baby, crying for the baby), difficulty coping (difficulty in dealing with normal activities with other people, withdrawal and depression), and despair (feelings of worthlessness and hopelessness). Each item is scored on a 5-point likert scale, resulting in a possible range of 33-165. Higher scores reflect more intense grief.
Time frame
2 weeks after final contact moment or 6 months post inclusionSecondary outcomes
1
Parental feasibility and acceptability of pilot
Parental feasibility and acceptability of pilot. As assessed by means of interviews.
Time frame
2 weeks after final contact moment or 6 months post inclusion2
Healthcare provider feasibility and acceptability of pilot
Healthcare provider feasibility and acceptability of pilot. As assessed by means of interviews.
Time frame
2 weeks after final contact moment or 6 months post inclusionSponsors and contacts
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Source ClinicalTrials.gov