About this trial
The goal of this feasibility randomised control trial is to determine if a trial to evaluate perinatal bereavement counselling for parents who have experienced a perinatal death is feasible. The main question it aims to answer is:
• Is a trial to evaluate access to perinatal bereavement counselling feasible?
Researchers will compare the intervention group (parents who have received counselling) to the control group (parents who have not received counselling) to see if there are differences in measurements of parents' grief and psychological symptoms.
* Participants allocated to the intervention and control group will receive usual bereavement care from the perinatal bereavement team at the hospital * Parents allocated to the intervention group will receive counselling * Parents will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life * Parents in the intervention group will be asked a series of open-ended written questions about their experience of participating in the trial * Healthcare professionals who have been involved with delivery of the intervention/referrals will be interviewed about their experience of the trial.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Women and partners of women who have had a late fetal loss (from 16 weeks), stillbirth or neonatal death within the maternity unit at Wythenshawe Hospital.
For the qualitative interviews, healthcare professionals who have been involved with referrals to the intervention and/or the delivery of the intervention
Disqualifiers
Less than 16 years of age
Anyone who lacks the capacity to consent
Inability to read English (interpreters will be provided for counselling sessions and interviews if needed).
Trial design
Parallel
Treatments tested in this trial
Bereavement Counselling
Other interventionBereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death
Usual bereavement care
Other interventionRoutine hospital bereavement care: regular phone calls, face-to-face meetings, access to bereavement resources via Padlet, invitations to coffee mornings, information about SANDS (Stillbirth and Neonatal Death Society) groups, and referrals to apps to access support
Treatment groups
Trial outcomes
Primary outcomes
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)
Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)
Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.
Participants' psychological outcomes - Perinatal Grief - assessed by the Perinatal Grief Scale (PGS; Toedter et al., 1988)
Perinatal Grief Scale (PGS; Toedter et al., 1988). 1 (Strongly Agree) to 5 (Strongly Disagree). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.
Participants' Psychological Outcome - Distress - Assessed by the Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013)
Clinical Outcomes in Routine Evaluation (CORE-10) score (Barkham et al., 2013). 0 (Not At All) to 4 (Most of the Time). Higher scores mean a worse outcome. Completed by participants online via Qualtrics.
Secondary outcomes
Descriptions of participants' experiences of their involvement in the study
Open-ended questions requiring a written response on the second questionnaire for intervention participants
Descriptions of healthcare professionals' experiences of their involvement in the study
Semi-structured interviews with 4 healthcare professionals involved in the trial
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: