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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.
In 2022, there were 4 stillbirths and 2.9 neonatal deaths for every 1,000 babies born in England and Wales. Despite the frequency of perinatal deaths, currently, there is no consistent provision of perinatal bereavement counselling for parents after stillbirth. This single-centre study aims to determine whether a randomised control trial to evaluate perinatal bereavement counselling is feasible. It will provide essential information to underpin a larger study which will give a more definite answer about the benefit of perinatal counselling. The larger study will inform national clinical practice guidelines by providing evidence for policymakers and professionals to make recommendations about whether perinatal counselling should be offered following stillbirth or neonatal death. The investigators will recruit mothers and partners from Manchester University National Health Service (NHS) Foundation Trust on the bereavement suite on the birth centre at Wythenshawe Hospital (where there is currently no perinatal bereavement counselling service). Parents will be eligible if they have experienced the death of a baby within the maternity setting at Wythenshawe Hospital. The investigators aim for 13 participants to receive the intervention and 13 participants to be allocated to the control group. 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 also receive 6-8 sessions of counselling over a 3-4-month period from a trained bereavement counsellor. Participants will complete validated psychometric questionnaires about their levels of perinatal grief, psychological distress, depression, and quality of life which will be administered at 2 months postnatal (before counselling begins), at 7-9 months postnatal (after counselling ends), and 12 months postnatal (follow-up). Parents in the intervention group will also answer (in writing) a series of open-ended questions about their experience of engaging with the trial on their 7-9 month questionnaire. The investigators will also interview approximately 4 healthcare professionals who have been involved with delivery of the intervention/referrals during the trial about their experience of the trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bereavement Counselling | Experimental | Bereavement counselling from a specialist bereavement counsellor |
|
| Usual bereavement care | Active Comparator | Routine care provided by the bereavement team |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bereavement Counselling | Other | Bereavement counselling for 6-8 sessions over a 3-month period beginning 3-4 months after a perinatal death |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline |
| 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. | 7-9 months postnatal |
| 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. | 12 months postnatal |
| 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. | Baseline |
| 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. | 7-9 months postnatal |
| Measure | Description | Time Frame |
|---|---|---|
| Descriptions of participants' experiences of their involvement in the study | Open-ended questions requiring a written response on the second questionnaire for intervention participants | 7-9 months post-loss |
| Descriptions of healthcare professionals' experiences of their involvement in the study |
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Inclusion Criteria:
Exclusion Criteria:
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| Usual bereavement care | Other | Routine 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 |
|
| 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. | 12 months postnatal |
| Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | Baseline |
| Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | 7-9 months postnatal |
| Participants' Psychological Outcomes - Depression - Assessed by the Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987) | Edinburgh Postnatal Depression Scale (EPDS; Cox et al., 1987). Items 1, 2, & 4: Scored 0 to 3 (0 being "As much as I always could" and 3 being "Not at all"). Items 3, 5-10 (Reverse Scored): Scored 3 to 0 (3 being "Yes, most of the time" or "Yes, quite often", 0 being "No, not at all"). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | 12 months postnatal |
| Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L) | Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | Baseline |
| Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L) | Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | 7-9 months postnatal |
| Participants' Quality of Life - Assessed by the Health Questionnaire (EQ-5D-5L) | Health Questionnaire (EQ-5D-5L). 1 (No Problems) to 5 (Extreme Problems). Higher scores mean a worse outcome. Completed by participants online via Qualtrics. | 12 months postnatal |
| Participation Rate | The proportion of eligible parents who agreed to participate | Through study completion, an average of 1.5 years |
| Intervention Completion Rate | The proportion of participants who completed the counselling intervention | Through study completion, an average of 1.5 years |
| Study Procedure Completion Rate | The proportion of participants who completed all of the study procedures | Through study completion, an average of 1.5 years |
Semi-structured interviews with 4 healthcare professionals involved in the trial |
| One interview for 50 minutes 1-2 weeks following the end of the trial |
| ID | Term |
|---|---|
| D050497 | Stillbirth |
| D066087 | Perinatal Death |
| ID | Term |
|---|---|
| D005313 | Fetal Death |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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