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Completed

NCT Number: NCT06590376

The Effect of Midwifery Care Given to Couples Experiencing Pregnancy Loss on 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.

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Key information

Conditions

Pregnancy Loss Bereavement Care Pattern, Maternal Grief Loss Pregnancy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Üsküdar University

Istanbul, Üsküdar, 34674, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

midwifery care based on swanson care theory

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.

Primary outcomes

  1. perinatal grief level

    Time frame: 30 days/1 month

    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.

  2. General Well-Being Scale Short Form

    Time frame: 30 days later

    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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Collaborators

  • Uskudar University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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