The Effect of Midwifery Care Given to Couples Experiencing Pregnancy Loss on Grief and General Well-Being

NCT ID: NCT06590376

Last Updated: 2024-09-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-07-15

Brief Summary

This study was designed as a randomised controlled, 2-group, pre-test-post-test comparative, experimental study to increase the general well-being of women experiencing pregnancy loss and to decrease the level of perinatal grief.

Detailed Description

Objective: The aim of this study was to examine the effect of midwifery care and counselling based on Swanson Care Theory for couples experiencing pregnancy loss on womens perinatal grief and general well-being levels.

Method: The study had an experimental two-group pretest-posttest design. Midwifery care and counselling based on Swanson Care Theory is a grief support program consisting of eight interviews, including four face-to-face interviews after the woman's admission to the clinic and four telephone interviews until the 30th day after discharge. The study was conducted with 76 couples admitted to the obstetrics and gynecology department of a training and research hospital in Istanbul between August 2023 and May 2024 with a diagnosis of pregnancy loss. The intervention group (n=38) received midwifery care and counselling based on Swanson Care Theory in addition to routine midwifery care in accordance with clinical procedures, whereas the control group (n=38) received only routine midwifery care in accordance with clinical procedures. This study used the Women Experiencing Pregnancy Loss Introductory Information Form, Men Experiencing Pregnancy Loss Introductory Information Form, Perinatal Bereavement Scale, and General Well-Being Scale.

Conditions

Pregnancy Loss; Grief; Loss Pregnancy; Care Pattern, Maternal; Bereavement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Intervention group (Group receiving midwifery care based on Swanson Care Theory)

After randomization of the women who were allocated to the clinic, they were informed about the research and their consent was obtained; then, the Women's Introductory Information Form, General Well-Being Scale, Perinatal Bereavement Scale, and the Male Introductory Information Form were completed by their husbands. The intervention group (n=38) received midwifery care based on Swanson Care Theory in addition to routine care in accordance with clinical procedures. The control group (n=38) received only routine care in accordance with the clinical procedures. For the participants in the intervention group, a practitioner's guide based on the Swanson Care Theory consisting of the stages of 'Knowing, ' 'Being together,' 'Meeting the needs,' 'Empowering' and 'Maintaining faith' was created. In this guideline, eight interviews were conducted, four face-to-face in the clinic and four by telephone after discharge. In the first interview, immediately after the woman was admitted to the clinic

Group Type: EXPERIMENTAL

midwifery care based on swanson care theory

Intervention Type: OTHER

All stages in the Midwifery Care and Counselling Practitioner Guide for Couples Experiencing Pregnancy Loss, which was developed by the researcher and included care, education and midwife counselling consisting of eight interviews, four of which were face-to-face and four by telephone, were applied.

Control group

The women and their husbands who were assigned to this group in a randomised controlled trial were interviewed after admission to the clinic and given detailed information about the study and a consent form was filled out. Women's Introductory Information Form and General Well-Being Scale Short Form, Perinatal Bereavement Scale Short Version and Male Introductory Information Form were filled out for their husbands.

During the study period, women in this group received routine midwifery care and counselling in accordance with hospital and clinical procedures. Clinical procedures included physiological care such as bleeding control and monitoring of vital signs during termination of pregnancy. No care procedures other than physiological care were applied.

On the thirtieth day after the woman was discharged from the clinic, the General Well-Being Scale and Perinatal Bereavement Scale were completed by telephone interview method.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

midwifery care based on swanson care theory

All stages in the Midwifery Care and Counselling Practitioner Guide for Couples Experiencing Pregnancy Loss, which was developed by the researcher and included care, education and midwife counselling consisting of eight interviews, four of which were face-to-face and four by telephone, were applied.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• To agree to participate in the research with a partner.
• Speak and understand Turkish.
• To be 18 years of age or older.
• To be at least primary school graduate.
• Having experienced loss after spontaneous pregnancy.
• Not being diagnosed with a psychiatric illness.

Exclusion Criteria

• Pregnancy loss due to medical termination
• Being pregnant with assisted reproductive techniques and experiencing pregnancy loss

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: collaborator

Istanbul University - Cerrahpasa

OTHER

Sponsor Role: lead

Responsible Party

Ayça Demir Yıldırım, PhD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayça DEMİR YILDIRIM, Phd

Role: STUDY_CHAIR

Üsküdar Üniversitesi

Locations

Üsküdar University

Istanbul, Üsküdar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

BETÜL ALTAY

Identifier Type: OTHER

Identifier Source: secondary_id

ÜskudarU Betül Altay

Identifier Type: -

Identifier Source: org_study_id