Evidence map›Paper›PMID 35668502›Full record

ArticleTrials2022

Living with Loss: study protocol for a randomized controlled trial evaluating an internet-based perinatal bereavement program for parents following stillbirth and neonatal death.

Siobhan A Loughnan, Frances M Boyle, David Ellwood, Sara Crocker, Ann Lancaster, Chrissie Astell, Julie Dean, Dell Horey, Emily Callander, Claire Jackson and 2 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.5field-weighted citation impact, top 18% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 8 citations in OpenAlex.

  1. Article
  2. Support for parents and families after stillbirth and neonatal death.The Cochrane database of systematic reviews · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 5 institutions in 1 country.

Siobhan A LoughnanNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia. siobhan.loughnan@mater.uq.edu.au.ORCID http://orcid.org/0000-0002-8763-2822
Frances M BoyleNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
David EllwoodNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Sara CrockerNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Ann LancasterNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Chrissie AstellNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Julie DeanNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Dell HoreyNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
Emily CallanderMonash University, 553 St Kilda Road, Melbourne, VIC, Australia.
Claire JacksonThe University of Queensland, St Lucia, QLD, Australia.
Antonia ShandFaculty of Medicine and Health, The University of Sydney, Camperdown, NSW, Australia.
Vicki FlenadyNHMRC Centre of Research Excellence in Stillbirth, Mater Research Institute-University of Queensland, Raymond Terrace, Level 3 Aubigny Place, South Brisbane, QLD, Australia.
The University of Queensland · AUQueensland Department of Natural Resources, Mines and Energy · AUGriffith University · AUMonash University · AUThe University of Sydney · AU

Funding

Australian Government's Medical Research Future Fund (MRFF) Rapid Applied Research Translation program Awarded to Brisbane Diamantina Health Partners (now known as Health Translation Queensland)
6 · The paper itself

Abstract

backgroundStillbirth and neonatal death are devastating pregnancy outcomes with long-lasting psychosocial consequences for parents and families, and wide-ranging economic impacts on health systems and society. It is essential that parents and families have access to appropriate support, yet services are often limited. Internet-based programs may provide another option of psychosocial support for parents following the death of a baby. We aim to evaluate the efficacy and acceptability of a self-guided internet-based perinatal bereavement support program "Living with Loss" (LWL) in reducing psychological distress and improving the wellbeing of parents following stillbirth or neonatal death.

methodsThis trial is a two-arm parallel group randomized controlled trial comparing the intervention arm (LWL) with a care as usual control arm (CAU). We anticipate recruiting 150 women and men across Australia who have experienced a stillbirth or neonatal death in the past 2 years. Participants randomized to the LWL group will receive the six-module internet-based program over 8 weeks including automated email notifications and reminders. Baseline, post-intervention, and 3-month follow-up assessments will be conducted to assess primary and secondary outcomes for both arms. The primary outcome will be the change in Kessler Psychological Distress Scale (K10) scores from baseline to 3-month follow-up. Secondary outcomes include perinatal grief, anxiety, depression, quality of life, program satisfaction and acceptability, and cost-effectiveness. Analysis will use intention-to-treat linear mixed models to examine psychological distress symptom scores at 3-month follow-up. Subgroup analyses by severity of symptoms at baseline will be undertaken. DISCUSSION: The LWL program aims to provide an evidence-based accessible and flexible support option for bereaved parents following stillbirth or neonatal death. This may be particularly useful for parents and healthcare professionals residing in rural regions where services and supports are limited. This RCT seeks to provide evidence of the efficacy, acceptability, and cost-effectiveness of the LWL program and contribute to our understanding of the role digital services may play in addressing the gap in the availability of specific bereavement support resources for parents following the death of a baby, particularly for men.

trial registrationAustralian New Zealand Clinical Trials Registry, ACTRN12621000631808 . Registered prospectively on 27 May 2021.

Indexed as

BereavementPerinatal DeathAustraliaFemaleGriefHumansInfant, NewbornInternetMaleParentsPregnancyQuality of LifeRandomized Controlled Trials as TopicStillbirthAnxietyBereavementDistressGriefInternetNeonatal deathOnlinePerinatalPregnancy lossStillbirth

Identifiers

PMID35668502
PMCPMC9167910
OpenAlexW4281939131

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.