Psychological Well-beingNCT05333653
Supportive Care During Childbirth and Well-being
A study testing Continouse supportive care and routine care in people with Psychological Well-being and Childbirth, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at birth on some parameters of maternal psychological well-being. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Psychological Well-being, Childbirth, Care Pattern, Maternal
- What is being tested?
- Continouse supportive care and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Dec 2020to 27 Jun 2021
- 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 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The ages of 18-40 women,
- At least primary school graduate,
- Mother tongue Turkish,
- Single fetus,
- Term,
- Spontaneous birth,
Show all 9Show fewer
- Cervical dilatation between 0-6 cm (latent phase) and without a condition that could prevent vaginal delivery.
- Primiparous and multiparous women
- Not have any disease or complication and agreed to participate in the study were included.
Who cannot join
- Women who developed a complication with the fetus or themselves during delivery,
- Underwent emergency cesarean section,
- Not be reached during follow-ups by telephone,
- Wanted to withdraw from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Continous Supportive Care at Childbirth on Maternal Psychological Well-being: A Single-blind Randomized Controlled Trial
The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at birth on some parameters of maternal psychological well-being.
Read the detailed description
This is a single-blind randomized controlled trial. Data were collected from 80 women who gave birth in the obstetrics clinic of a state hospital in the south of Turkey between December 2020 and June 2021. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
- Conditions
- Psychological Well-being, Childbirth, Care Pattern, Maternal
- Being tested
- Continouse supportive care, routine care
- Keywords
- Intrapartum supportive care, birth trauma, fear of childbirth, maternal attachment, perinatal well-being
- Medical subject headings
- Psychological Well-Being, Birth Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continouse supportive careOther
Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences.
Participants in the control group, on the other hand, received routine care given in the hospital by other midwives in the clinic.
routine careOther
Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Continous Supportive Care | Experimental | Participants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences. Receives: Other: Continouse supportive care |
| Control | Experimental | Participants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fear of Childbirth (DFS)
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS).
This scale was developed by Wijma et al (2002) for fear during delivery. The Turkish validity and reliability of the scale were performed by Sercekus et al. (2017). This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear.
Measured: through delivery, an average of 24th hours
Perceived control and support in birth (SCIB)
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale.
SCIB was developed by Ford et al., (2009) to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed by Inci et al. (2015). This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 (Ford et al., 2009) and Turkish version was measured as 0.84 (Inci et al.,2015). In this study, this scale was administered within 24 hours postpartum.
Measured: Postpartum 24th hours
Birth Trauma (City BITS)
Birth trauma of women were evaluated with the City Birth Trauma Scale. City BiTS was developed by Ayers et al., (2018) to measure birth trauma. The Turkish validity and reliability of the scale were performed by Bayrı Bingöl et al. (2021). The scale is a fourpoint Likert-type instrument composed of 29 items. Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD). The Cronbach's alpha for the original scale was measured as .92 (Ayers et al.,2018) and Turkish version was measured as 0.91 (Bayrı Bingöl et al., 2021). In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.
Measured: Postpartum 8 th week
Maternal Attachment (MAI)
Maternal attachment of women was evaluated with the Maternal Attachment Inventory.
MAI, was developed by Muller (1994) to measure maternal attachment. The Turkish validity and reliability of the scale were performed by Kavlak et al. (2009). This scale consisting of 26 items is a 4-point Likert-type (4 = every time to 1 = any time). The scores ranged from 26 to 104 and high scores indicated higher maternal attachment. The Cronbach's alpha for the original scale was measured as .76 - .85 at different time (Muller, 1994) and Turkish version was measured as 0.77 (Kavlak et al., 2009). In this study, 6th to 8th postnatal days were used to measure maternal attachment.
Measured: Postpartum 8 th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2022
- Study start15 Dec 2020
- Primary completion15 Mar 2021
- Study completion27 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychological Well-beingStudies of the same condition, open and under way.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gozde Gokce Isbir, Mersin University
- Investigators
- Gozde Gokce Isbir, Principal investigator, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05333653
- Sponsor's protocol ID
- GIsbir
- Status last verified
- Apr 2022
- First submitted
- 2 Feb 2022
- Last updated
- 19 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continous Supportive Care at Childbirth on Maternal Psychological Well-being: A Single-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05333653
- Acronym / sponsor ID
- GIsbir
- Conditions
- Psychological Well-being, Childbirth, Care Pattern, Maternal
- Keywords
- Intrapartum supportive care, birth trauma, fear of childbirth, maternal attachment, perinatal well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 27 Jun 2021 (actual)
- First posted
- 19 Apr 2022 (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.
The aim of this study is to evaluate the effects of continuous supportive care (ICSC) at birth on some parameters of maternal psychological well-being.
Detailed description
This is a single-blind randomized controlled trial. Data were collected from 80 women who gave birth in the obstetrics clinic of a state hospital in the south of Turkey between December 2020 and June 2021. Participants who met the inclusion criteria were informed about the purpose of the study and the procedures to be performed, informed consent was obtained from those who agreed to participate, and women were assigned to the groups in line with a computer-based randomization program with an allocation ratio of 1:1. Block randomization could not be performed because of the different and long delivery processes. Data were collected in both groups at birth (latent phase, active phase, and transitional phase), within 24 hours of birth, and 6th-8th postpartum days after hospital admission and at least one hour of care. collected by the first author. The CONSORT directive was followed in the planning, implementation and writing of the research.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continous Supportive Care | Experimental | Other: Continouse supportive careParticipants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences. |
| Control | Experimental | Other: routine careParticipants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- The ages of 18-40 women,
- At least primary school graduate,
- Mother tongue Turkish,
- Single fetus,
- Term,
Key exclusion criteria (4 listed)
- Women who developed a complication with the fetus or themselves during delivery,
- Underwent emergency cesarean section,
- Not be reached during follow-ups by telephone,
- Wanted to withdraw from the study
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 |
|---|---|---|
| Continouse supportive careParticipants were provided care in different rooms, blinded to the differences in practice used between the two groups. In the same clinic, a room was designed as a positive delivery room by the researchers and a relaxing environment was created. In this room, supportive care parameters recommended by The Royal College of Midwives (2012) were applied to the women in the ICSC group in line with their preferences. Participants in the control group, on the other hand, received routine care given in the hospital by other midwives in the clinic. | Other | Continous Supportive Care |
| routine careParticipants in the control group, on the other hand, received the routine care given in the hospital by other midwives in the clinic, and there was a change of caregiver midwife during shift changes. The care provided in the hospital during delivery is mostly focused on low level of physical comfort and high level of follow-up. | Other | Control |
Primary outcome
Fear of Childbirth (DFS)
Time frame: through delivery, an average of 24th hours
Women's fears at the time of birth were evaluated with the Delivery fear scale (DFS). This scale was developed by Wijma et al (2002) for fear during delivery. The Turkish validity and reliability of the scale were performed by Sercekus et al. (2017). This scale consisting of 10 items is a 10-point Likert-type. The positive-meaning items are scored in reverse order. Therefore, the scores ranged from 10 to 100. The scale has no cutoff score, and high scores indicated higher fear.
Perceived control and support in birth (SCIB)
Time frame: Postpartum 24th hours
Women's perceptions of support and control at the time of birth were evaluated with the Perceived control and support in birth scale. SCIB was developed by Ford et al., (2009) to measure perceived support and control in birth. The Turkish validity and reliability of the scale were performed by Inci et al. (2015). This scale consisting of 33 items is a 5-pointLikert-type (5 = agree completely to 1 = disagree completely). Ten items are scored in reverse order. The scores ranged from 33 to 165. SCIB subscales include internal control, external control, and support. The scale has no cutoff score, higher scores are associated with a higher degree of perceived support and of control during birth. The Cronbach's alpha for the original scale was measured as .95 (Ford et al., 2009) and Turkish version was measured as 0.84 (Inci et al.,2015). In this study, this scale was administered within 24 hours postpartum.
Birth Trauma (City BITS)
Time frame: Postpartum 8 th week
Birth trauma of women were evaluated with the City Birth Trauma Scale. City BiTS was developed by Ayers et al., (2018) to measure birth trauma. The Turkish validity and reliability of the scale were performed by Bayrı Bingöl et al. (2021). The scale is a fourpoint Likert-type instrument composed of 29 items. Higher scores reflect greater risk for Post-traumatic Stress Disorder (PTSD). The Cronbach's alpha for the original scale was measured as .92 (Ayers et al.,2018) and Turkish version was measured as 0.91 (Bayrı Bingöl et al., 2021). In this study, 6-8 days after birth to determine whether they meet the criteria for birth trauma and birth-related PTSD.
Maternal Attachment (MAI)
Time frame: Postpartum 8 th week
Maternal attachment of women was evaluated with the Maternal Attachment Inventory. MAI, was developed by Muller (1994) to measure maternal attachment. The Turkish validity and reliability of the scale were performed by Kavlak et al. (2009). This scale consisting of 26 items is a 4-point Likert-type (4 = every time to 1 = any time). The scores ranged from 26 to 104 and high scores indicated higher maternal attachment. The Cronbach's alpha for the original scale was measured as .76 - .85 at different time (Muller, 1994) and Turkish version was measured as 0.77 (Kavlak et al., 2009). In this study, 6th to 8th postnatal days were used to measure maternal attachment.
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 19 Apr 2022.
- Individual participant dataSharing planned: No
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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.
Gozde Gokce Isbir principal investigator
Mersin 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 Continouse supportive care and routine care in people with Psychological Well-being and Childbirth, run by Mersin University 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 9 inclusion and 4 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 19 Apr 2022. 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?
Fear of Childbirth (DFS) (time frame: through delivery, an average of 24th hours). The study lists 4 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 19 Apr 2022.