Continuous Birth SupportNCT05720962
The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
A study testing uninterrupted accompanying support in people with Continuous Birth Support, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Continuous Birth Support
- What is being tested?
- uninterrupted accompanying support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 1 Mar 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-35 years old
- Being literate
- Fluent and speaking Turkish
- Primiparous
- Spontaneous vaginal delivery planned
- At the beginning of the active phase (dilatation 4 cm)
- Pregnant women who agreed to participate in the research
Who cannot join
- Presence of a health problem in the mother during pregnancy
- At risk of fetal anomaly
- Having multiple pregnancy
- Administering analgesic medication during labor
Trial locations and contacts
1 site in 1 country.
About this study
This study was planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.
Read the detailed description
Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.
This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".
The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.
- Conditions
- Continuous Birth Support
- Being tested
- uninterrupted accompanying support
- Keywords
- continuous birth support, birth time, labor pain, satisfaction
- Medical subject headings
- Labor Pain, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uninterrupted accompanying supportProcedure or surgery
When the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them.
Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | The experimental group will be provided with routine midwife support and uninterrupted accompanying support. Receives: Procedure: uninterrupted accompanying support |
| control group | No intervention | Only routine midwife support will be provided to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS)
It is a reliable and easily applicable scale accepted in the world literature. It is used to measure the values that cannot be measured numerically in the evaluation of the pain intensity and satisfaction of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. Additionally, higher scores indicate higher pain intensity, higher satisfaction.
Measured: "through study completion, an average of 1 year"
Personal information form
It is a form that includes questions that determine socio-demographic characteristics and perception of support. The form also includes questions about the process of the birth period.
Measured: "through study completion, an average of 1 year".
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2024
- Study completion1 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Birth SupportStudies 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
- randomized controlled study with two groups as control and experimental group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, dilan cömert, Istanbul University - Cerrahpasa
- Investigators
- Dilan Cömert, Principal investigator, Msc Midwife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720962
- Sponsor's protocol ID
- 2022/401
- Status last verified
- Mar 2024
- First submitted
- 23 Jan 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- 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 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Continuous Accompanying Support in the Active Phase on Labor Pain, Duration and Satisfaction
- ClinicalTrials.gov ID
- NCT05720962
- Acronym / sponsor ID
- 2022/401
- Conditions
- Continuous Birth Support
- Keywords
- continuous birth support, birth time, labor pain, satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Mar 2024 (actual)
- First posted
- 9 Feb 2023 (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 planned to determine the effect of continuous accompanying support during the active phase on labor pain, duration and satisfaction.
Detailed description
Participants who comes into childbirth needs the support of people around her in order to cope with the stress, anxiety and labor pain she experiences. This support is the continuous birth support given from the time the participants comes to the hospital until the birth of the baby. Having someone who supports the woman during the birth process will provide a positive birth experience for pregnant women. At the same time, the feeling of pain of the supported woman will be reduced and the delivery time will be shortened.
This randomized controlled study was planned to be performed on primiparous pregnant women between January 2023 and January 2024. The data of the study will be collected with "Personal Information Form", "Visual Analog Scale".
The study was divided into two groups as experimental and control groups. 55 participants in the experiment -55 participants will be randomized to the control group. Participants meeting the inclusion criteria will be asked to rate their pain and satisfaction from 0 to 10 with the VAS 4 cm, 6 cm, 8 cm and fully open. While both groups receive routine midwife support, when the experimental group reaches 4 cm, a person they want will be taken with them and continuous support will be given until there is a dilation of 10 cm.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled study with two groups as control and experimental group
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Procedure: uninterrupted accompanying supportThe experimental group will be provided with routine midwife support and uninterrupted accompanying support. |
| control group | No intervention | –Only routine midwife support will be provided to the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 18-35 years old
- Being literate
- Fluent and speaking Turkish
- Primiparous
- Spontaneous vaginal delivery planned
Key exclusion criteria (4 listed)
- Presence of a health problem in the mother during pregnancy
- At risk of fetal anomaly
- Having multiple pregnancy
- Administering analgesic medication during labor
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 |
|---|---|---|
| uninterrupted accompanying supportWhen the participants in the experimental group are taken to the delivery unit, when the neck dilation is 4 cm, a person they want will be taken with them to support them. Afterwards, the pain status and satisfaction of the participants will be questioned when it is 4 cm, 6 cm, 8 cm and 10 cm. | Procedure or surgery | experimental group |
Primary outcome
Visual Analog Scale (VAS)
Time frame: "through study completion, an average of 1 year"
It is a reliable and easily applicable scale accepted in the world literature. It is used to measure the values that cannot be measured numerically in the evaluation of the pain intensity and satisfaction of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. Additionally, higher scores indicate higher pain intensity, higher satisfaction.
Personal information form
Time frame: "through study completion, an average of 1 year".
It is a form that includes questions that determine socio-demographic characteristics and perception of support. The form also includes questions about the process of the birth period.
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 6 Mar 2024.
- 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.
Dilan Cömert principal investigator
Msc Midwife
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uninterrupted accompanying support in people with Continuous Birth Support, 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 7 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 6 Mar 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?
Visual Analog Scale (VAS) (time frame: "through study completion, an average of 1 year"). 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 6 Mar 2024.