NCT06652373

Brief Summary

Perinatal bereavement is a condition that can lead to serious psychological problems for parents and their families. Bereaved women are at high risk of mental health problems (e.g. anxiety, post-traumatic stress disorder and depression). They may also blame themselves and their bodies for the loss and feel inadequate. Inadequate support from their environment in this process may lead them to experience social isolation. Research highlights the impact of caring for bereaved parents on health professionals, and that inadequate training can have a negative impact. In this context, there is a need for well-structured and tailored training programmes that focus on the specific needs and skills required to provide appropriate bereavement care to parents experiencing pregnancy loss and perinatal death. In this context, this study was planned both to prepare a training programme with evidence of effectiveness and to investigate the effectiveness of perinatal bereavement counselling training for midwives.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 22, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

September 12, 2024

Last Update Submit

October 19, 2024

Conditions

Keywords

BereavementHospice CareResearch DesignMidwiferyPregnancy

Outcome Measures

Primary Outcomes (1)

  • Perinatal Bereavement Care Confidence Scale

    Perinatal Bereavement Care Confidence Scale (PBCCS)The validity and reliability of the scale developed by Kalu et al. in 2019 to evaluate the perinatal grief process and care in this process was developed by Dursun and Akkuş. This measurement tool was developed to determine the grief care confidence of midwives and nurses who provide support to parents experiencing perinatal loss. The scale consists of 35 items and 4 sub-dimensions. The items of the scale, which has a 5-point Likert structure, are scored as strongly agree=5, agree=4, partially agree=3, disagree=2, strongly disagree=1. While the minimum score to be obtained from each dimension is 1, the maximum score is 5. The statements with reversed items are 7, 11 and 33. Low scores obtained from the scale indicate a high level of confidence in perinatal bereavement support. The scale does not have a total score and each factor is scored independently. In the scale; each dimension is evaluated separately within itself.

    1 week before the start of the training and 1 week after the end of the training

Study Arms (2)

Education

EXPERIMENTAL

perinatal grief counselling training for midwives will be given to the experimental group.

Behavioral: Behavioural change through education

Standard of care

NO INTERVENTION

The training will not be given to the control group during the study.

Interventions

The content of the perinatal grief counselling training to be used in the study will be created in 8 modules and will be applied to midwives. The planned perinatal grief counselling training for midwives will be carried out online and it is aimed that midwives gain perinatal grief counselling skills and competence and increase their competence to cope with the problems they may encounter in the counselling process.

Education

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility Detailswomen midwives
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Midwives who have been active midwives in one of the obstetrics, postnatal, perinatology, septic and aseptic services for at least one year

You may not qualify if:

  • Academic and freelance midwives
  • Midwives who have previously received specialised training in bereavement care

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ayse Irem Gokcek

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD student in midwifery

Study Record Dates

First Submitted

September 12, 2024

First Posted

October 22, 2024

Study Start

December 1, 2024

Primary Completion

April 1, 2025

Study Completion

December 30, 2025

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

I donot want to share