Pregnancy LossNCT06590376
The Effect of Midwifery Care Given to Couples Experiencing Pregnancy Loss on Grief and General Well-Being
A study testing midwifery care based on swanson care theory in people with Pregnancy Loss and Grief, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pregnancy Loss, Grief, Loss Pregnancy
- What is being tested?
- midwifery care based on swanson care theory
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 15 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Pregnancy loss due to medical termination
- Being pregnant with assisted reproductive techniques and experiencing pregnancy loss
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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
- Being tested
- midwifery care based on swanson care theory
- Keywords
- Midwifery, pregnancy loss, perinatal bereavement, bereavement care guide, midwifery care and counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midwifery care based on swanson care theoryOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Intervention group (Group receiving midwifery care based on Swanson Care Theory) | Experimental | 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 Receives: Other: midwifery care based on swanson care theory |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 30 days later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Aug 2023
- Primary completion1 Jul 2024
- Study completion15 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy LossStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Collaborators
- Uskudar University
- Responsible party
- Principal investigator, Ayça Demir Yıldırım, PhD, Istanbul University - Cerrahpasa
- Investigators
- Ayça DEMİR YILDIRIM, Phd, Study chair, Uskudar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06590376
- Sponsor's protocol ID
- ÜskudarU Betül Altay
- Other IDs
- BETÜL ALTAY
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 27 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: A research paper was planned to make individual participant data (IPD) available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06590376
- Acronym / sponsor ID
- ÜskudarU Betül Altay
- Conditions
- Pregnancy Loss, Grief, Loss Pregnancy, Care Pattern, Maternal, Bereavement
- Keywords
- Midwifery, pregnancy loss, perinatal bereavement, bereavement care guide, midwifery care and counselling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Collaborators
- Uskudar University
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research was designed as a randomized controlled, 2-group (intervention and control) pre-test post-test comparative experimental research.
| Arm | Type | Receives |
|---|---|---|
| Experimental Intervention group (Group receiving midwifery care based on Swanson Care Theory) | Experimental | Other: midwifery care based on swanson care theoryAfter 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 |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnancy loss due to medical termination
- Being pregnant with assisted reproductive techniques and experiencing pregnancy loss
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| midwifery care based on swanson care theoryAll 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. | Other | Experimental Intervention group (Group receiving midwifery care based on Swanson Care Theory) |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2024.
- Individual participant dataSharing planned: No. A research paper was planned to make individual participant data (IPD) available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça DEMİR YILDIRIM, Phd study chair
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing midwifery care based on swanson care theory in people with Pregnancy Loss and Grief, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perinatal grief level (time frame: 30 days/1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2024.