Childbirth ProblemsSupportBirthNCT06624748
Companions Who Support the Pregnant Woman During the Birth Process
A study testing emotional and physical support to the pregnant woman provided by attendant in people with Childbirth Problems and Support, Family, run by Selcuk University at 2 sites in Turkey (Türkiye).
Trial summary
In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Problems, Support, Family
- What is being tested?
- emotional and physical support to the pregnant woman provided by attendant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Sep 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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant women aged 37-42.
- Women who are planning to give birth vaginally during their first week of pregnancy.
- First-time pregnant women.
- Women with no vision, hearing, or communication problems.
- Women who can speak and express themselves in Turkish.
- Women who are willing to participate voluntarily in the study.
Who cannot join
- Pregnant women with multiple pregnancies.
- Women who are planned to give birth by cesarean section.
- Women with any complications during pregnancy.
- Women with chronic diseases.
- Pregnant women with verbal, mental, or other communication disabilities.
- Among the pregnant women included in the control or intervention group, those who:
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- Received epidural analgesia.
- Experienced instrumental delivery (with vacuum or forceps).
- Had postnatal complications in the newborn.
- Had complications related to episiotomy (such as 3rd and 4th degree laceration, hematoma).
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Selcuk University
Konya, 42100
Bihter Akın
Selçuklu, Konya, 42060
About this study
Official title: Evaluation of the Opinions of Companions Who Support the Pregnant Woman During the Birth Process: Mixed Method Study
In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level and positive birth outcomes, as well as the opinions of the people who provide support. Based on the results obtained and the positive contributions to maternal satisfaction during the labor process, birth and postpartum comfort process, mother-baby health, as well as the opinions of the companions, a 'Pregnant Support Guide in Labor' will be created and the companions will be enabled to support the pregnant woman in line with this guide. In addition, based on the opinions of the attendants, the researchers plan to develop the 'Birth Support Satisfaction Scale'.
Read the detailed description
Type of research The study is a Randomized Controlled Mixed Method study. Research Design This study is a mixed method study planned to be conducted to evaluate the effect of companion support on the labor process and the opinions of companions, using a randomized controlled experimental design and in-depth individual interview method. This clinical trial will be registered at ClinicalTrials.gov. Reporting will be adhered to CONSORT for parallel group randomized studies. (CONSORT 2010, Access date: 10 August 2022). The research is planned to be carried out in the delivery room of Sakarya Training and Research Hospital between 01 March 2023 and 30 December 2024.
Where the Research Will Be Conducted The study will be carried out in the delivery room of Sakarya Training and Research Hospital. Pregnant women who have started labor are admitted to the delivery room by a doctor, and labor follow-up is carried out by midwives and assistant doctors under the supervision of a gynecologist. On average, around 350 vaginal births occur monthly. Since the hospital is not mother-friendly, a companion is not allowed to accompany the pregnant woman in routine practices.
Data Collection Stages The intervention and control groups will be informed about the research, and a personal information form will be applied to pregnant women and their companions who accept it.
- Conditions
- Childbirth Problems, Support, Family
- Being tested
- emotional and physical support to the pregnant woman provided by attendant
- Keywords
- Pregnancy, Midwife
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional and physical support to the pregnant woman provided by attendantBehavioural
The companion will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, taking a warm shower, etc.), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| emotional and physical support to the pregnant woman provided by attendant | Experimental | Following the information, the attendant will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, giving the pregnant woman a warm shower), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded. Receives: Behavioral: emotional and physical support to the pregnant woman provided by attendant |
| Standard of care | No intervention | Women who are informed about the purpose and practices of the research and who agree to participate in the study voluntarily will not be deviated from routine practices in the hospital. Women who are followed and delivered by the same midwife will be included in the study to ensure that there is no difference between the groups in terms of episiotomy application and birth techniques. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Comfort Scale Score
The Birth Comfort Scale is a tool designed to evaluate the level of comfort experienced by women during labor and delivery. The scale measures the influence of physical, psychological, and environmental factors on comfort during childbirth. It allows women to assess aspects such as physical ease, pain management, a sense of security, and environmental support during labor. Typically, the scale follows a 5-point Likert format, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total comfort score can range from a minimum of 10 to a maximum of 50.
The scale demonstrates high internal consistency as measured by Cronbach's Alpha, with values typically ranging between 0.80 and 0.90, indicating that it is a reliable tool for assessing birth comfort.
Measured: At the time of cervical dilatation reaching 8 cm during the intrapartum period
Secondary outcomes (1)
Postpartum Comfort Scale
The Postpartum Comfort Scale is designed to assess the comfort levels of women during the postpartum period. The scale evaluates comfort in three key areas: physical, psychological, and socio-cultural. It measures factors such as physical discomforts, emotional state, social support, and environmental influences during the postnatal period. The scale is typically structured as a 5-point Likert scale, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total score indicates whether the woman's postpartum comfort is low or high.
The scale's Cronbach's Alpha is typically reported to be 0.85 or higher, indicating high reliability. This tool helps healthcare professionals better understand and address the needs of women during the postpartum period, leading to more effective interventions.
Measured: Two hours postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start1 Mar 2023
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childbirth ProblemsStudies of the same condition, open and under way.
- More trials run by Selcuk UniversityThe 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bihter Akın, Selcuk University
- Investigators
- Bihter Akın, Study chair, Selcuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06624748
- Sponsor's protocol ID
- 2023/1021
- Acronym
- SupportBirth
- Status last verified
- Oct 2024
- First submitted
- 9 Feb 2024
- Last updated
- 3 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Balcik Colak M, Akin B, Kalkan SC, Uslu Yuvaci H. Effects of labor support on pregnant women's childbirth comfort, satisfaction and postpartum comfort levels: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Jul 24;25(1):789. doi: 10.1186/s12884-025-07904-6.
PubMed 40707892
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Opinions of Companions Who Support the Pregnant Woman During the Birth Process: Mixed Method Study
- ClinicalTrials.gov ID
- NCT06624748
- Acronym / sponsor ID
- SupportBirth / 2023/1021
- Conditions
- Childbirth Problems, Support, Family
- Keywords
- Pregnancy, Midwife
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 3 Oct 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.
In our country, although there is currently an emphasis on companion support within the scope of mother-friendly hospitals, there is no guide for companions. This study was planned to determine the effect of women who have companion support during labor on birth satisfaction, birth comfort, postpartum comfort level and positive birth outcomes, as well as the opinions of the people who provide support. Based on the results obtained and the positive contributions to maternal satisfaction during the labor process, birth and postpartum comfort process, mother-baby health, as well as the opinions of the companions, a 'Pregnant Support Guide in Labor' will be created and the companions will be enabled to support the pregnant woman in line with this guide. In addition, based on the opinions of the attendants, the researchers plan to develop the 'Birth Support Satisfaction Scale'.
Detailed description
Type of research The study is a Randomized Controlled Mixed Method study. Research Design This study is a mixed method study planned to be conducted to evaluate the effect of companion support on the labor process and the opinions of companions, using a randomized controlled experimental design and in-depth individual interview method. This clinical trial will be registered at ClinicalTrials.gov. Reporting will be adhered to CONSORT for parallel group randomized studies. (CONSORT 2010, Access date: 10 August 2022). The research is planned to be carried out in the delivery room of Sakarya Training and Research Hospital between 01 March 2023 and 30 December 2024.
Where the Research Will Be Conducted The study will be carried out in the delivery room of Sakarya Training and Research Hospital. Pregnant women who have started labor are admitted to the delivery room by a doctor, and labor follow-up is carried out by midwives and assistant doctors under the supervision of a gynecologist. On average, around 350 vaginal births occur monthly. Since the hospital is not mother-friendly, a companion is not allowed to accompany the pregnant woman in routine practices.
Data Collection Stages The intervention and control groups will be informed about the research, and a personal information form will be applied to pregnant women and their companions who accept it.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| emotional and physical support to the pregnant woman provided by attendant | Experimental | Behavioral: emotional and physical support to the pregnant woman provided by attendantFollowing the information, the attendant will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, giving the pregnant woman a warm shower), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded. |
| Standard of care | No intervention | –Women who are informed about the purpose and practices of the research and who agree to participate in the study voluntarily will not be deviated from routine practices in the hospital. Women who are followed and delivered by the same midwife will be included in the study to ensure that there is no difference between the groups in terms of episiotomy application and birth techniques. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant women aged 37-42.
- Women who are planning to give birth vaginally during their first week of pregnancy.
- First-time pregnant women.
- Women with no vision, hearing, or communication problems.
- Women who can speak and express themselves in Turkish.
Key exclusion criteria (10 listed)
- Pregnant women with multiple pregnancies.
- Women who are planned to give birth by cesarean section.
- Women with any complications during pregnancy.
- Women with chronic diseases.
- Pregnant women with verbal, mental, or other communication disabilities.
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 |
|---|---|---|
| emotional and physical support to the pregnant woman provided by attendantThe companion will provide emotional and physical support to the pregnant woman (such as massage, supporting the pregnant woman while moving, taking a warm shower, etc.), and all interventions made by the companion and their duration will be recorded by the researcher in the 'Birth Process Support Form'. When the cervical dilatation is 8 cm, the Birth Comfort Scale will be applied to the pregnant woman, and two hours after the birth, the Birth Satisfaction Scale and the Postpartum Comfort Scale will be applied. Information about the birth process will be recorded in the Birth Information Form. In addition, semi-structured questions in the 'Companion Interview Form' will be asked to the companions selected for qualitative interviews and voice recording will be recorded. | Behavioural | emotional and physical support to the pregnant woman provided by attendant |
Primary outcome
Birth Comfort Scale Score
Time frame: At the time of cervical dilatation reaching 8 cm during the intrapartum period
The Birth Comfort Scale is a tool designed to evaluate the level of comfort experienced by women during labor and delivery. The scale measures the influence of physical, psychological, and environmental factors on comfort during childbirth. It allows women to assess aspects such as physical ease, pain management, a sense of security, and environmental support during labor. Typically, the scale follows a 5-point Likert format, with each item scored from 1 to 5 (1: Strongly disagree, 5: Strongly agree). The total comfort score can range from a minimum of 10 to a maximum of 50. The scale demonstrates high internal consistency as measured by Cronbach's Alpha, with values typically ranging between 0.80 and 0.90, indicating that it is a reliable tool for assessing birth comfort.
1 secondary outcome
Postpartum Comfort Scale
Time frame: Two hours postpartum
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 3 Oct 2024.
- Derived from this study: PubMed 40707892Balcik Colak M, Akin B, Kalkan SC, Uslu Yuvaci H. Effects of labor support on pregnant women's childbirth comfort, satisfaction and postpartum comfort levels: a randomized controlled trial. BMC Pregnancy Childbirth. 2025 Jul 24;25(1):789. doi: 10.1186/s12884-025-07904-6.
- 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.
Bihter Akın study chair
Selcuk University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional and physical support to the pregnant woman provided by attendant in people with Childbirth Problems and Support, Family, run by Selcuk University at 2 sites 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 10 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 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Birth Comfort Scale Score (time frame: At the time of cervical dilatation reaching 8 cm during the intrapartum period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06624748, which also lists 1 linked publication.
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 3 Oct 2024.