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

The Effect of Midwifery Care Based on Swanson Care Theory Given to Couples Experiencing Pregnancy Loss on the Level of Grief and General Well-Being

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.

Study Overview

• Status: Completed
• Conditions: Pregnancy Loss; Grief; Bereavement; Care Pattern, Maternal; Loss Pregnancy
• Intervention / Treatment: Other: midwifery care based on swanson care theory

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.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Üsküdar
    • Istanbul, Üsküdar, Turkey, 34674
      • Uskudar University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Other: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perinatal grief level	The Perinatal Grief Scale (32-item Short Version) developed by Toedter et al. consists of 32 items on a 5-point Likert scale. This scale assesses the degree of grief after perinatal loss. Each question on the scale was answered as 'Strongly agree, agree, undecided, disagree, strongly disagree. ' Active grief, hopelessness, and difficulty in coping were subscales of the scale. As the total perinatal grief score and the total score obtained from the subdimensions increased, it was determined that the grief level of the individual was higher. The total perinatal grief score obtained from the PMS was between 32-160. The Turkish validity and reliability of the scale was performed by 4 academicians in 2017 and the content validity index was found to be 0.95. In this study, the Cronbach's alpha value of the scale was 0.774.	30 days/1 month
General Well-Being Scale Short Form	The short form of the General Well-being Scale was created as a result of the factor analysis studies of the shortening of the General Well-being Scale consisting of 65 items developed by Longo et al. in 2017 to determine the well-being of individuals. The General Well-Being Scale Short Form consisted of 14 items. In the five-point Likert-type scale, there are items such as Everything I do is valuable. "1" is not true at all and "5" is always true. The Turkish validity and reliability of the scale was carried out by 3 academicians in 2021, and as a result of the reliability studies, the internal consistency coefficient and construct reliability of the scale were found to be 0.84 and the two-half test correlation was 0.77. In this study, Cronbach's alpha value of the scale was 0.848.	30 days later

Collaborators and Investigators

• Sponsor: Istanbul University - Cerrahpasa (IUC)
• Collaborators: Uskudar University
• Investigators: Study Chair: Ayça DEMİR YILDIRIM, Phd, Üsküdar Üniversitesi

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2023
• Primary Completion (Actual): July 1, 2024
• Study Completion (Actual): July 15, 2024

Study Registration Dates

• First Submitted: September 3, 2024
• First Submitted That Met QC Criteria: September 6, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): September 27, 2024
• Last Update Submitted That Met QC Criteria: September 25, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Midwifery; pregnancy loss; perinatal bereavement; bereavement care guide; midwifery care and counselling
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Death; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Abortion, Spontaneous; Fetal Death
• Other Study ID Numbers: ÜskudarU Betül Altay; BETÜL ALTAY (Other Identifier: USKUDARU)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: A research paper was planned to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No