Labor PainNCT07058168
The Effect of Labor Diet During the Delivery Process
A study testing Other: experimental group (labor diet) in people with Labor Pain and Labor, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
This study is a clinical trial. It aimed to examine the effects of the labor diet on pain, anxiety, fatigue, and thirst levels, maternal satisfaction during labor, in multiparous pregnant women (47 experiments; 47 controls) in the first stage of labor. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Labor, Diet
- What is being tested?
- Other: experimental group (labor diet)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2022to 30 Jun 2022
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Vaginal delivery,
- Who volunteered to participate in the research,
- Who with cervical dilatation less than 5 cm,
- who were suitable for oral intake
Who cannot join
- Who could not speak or understand Turkish,
- Have auditory or mental health problems,
- Who were under 18 years of age,
- Who were primiparous,
- Who were chronically ill and whose current pregnancy was risky
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Biruni University
Zeytinburnu, Istanbul, 34010
About this study
Official title: The Effect of Labor Diet Administered to Multiparous Pregnant Women on Mother and Baby During the Delivery Process
This study is a clinical trial. It aimed to examine the effects of the labor diet on pain, anxiety, fatigue, and thirst levels, maternal satisfaction during labor, in multiparous pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women with cervical dilatation less than 5 cm, and who were suitable for oral intake, and voluntarily accept to participate in the research were included in the study. Exclusion criteria from the study: Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; who could not speak or understand Turkish, who were under 18 years of age, who were primiparous, who were chronically ill and whose current pregnancy was risky. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours during labour. Pregnant women in the experimental group labor diet and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until labor. The main questions it aims to answer are: • Labor diet during labor; It is effective in reducing the level of pain. • Labor diet during labor; It is effective in reducing anxiety. • Labor diet during labor; It is effective in reducing thirst. • Labor diet during labor; It is effective in reducing fatigue. • Labor diet during labor; It is effective in increasing maternal satisfaction. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group labor diet also.
Read the detailed description
Objective: In this study, it was aimed to examine the effects of the labor diet on pain, anxiety, fatigue, and thirst levels, maternal satisfaction during labor, in multiparous pregnant women in the first stage of labor. Methods: The study was conducted in a randomized controlled experimental manner. The universe consisted of all pregnant women who applied to the delivery room of a public institution between February and June 2022. Power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. The study was started after the approval of the ethics committee and the institution. As a data collection tool in the research; "Personal Information Form","Women's Perception of Supportive Care Provided at Birth Scale" and "Pregnant and Infant Monitoring Form" were used.
- Conditions
- Labor Pain, Labor, Diet
- Being tested
- Other: experimental group (labor diet)
- Keywords
- labor, diet, labor diet, pregnant, delivery
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: experimental group (labor diet)Dietary supplement
The data collection tools "Personal Information Form", "Women's Perception of Supportive Care Provided at Birth Scale", and "Pregnant and Infant Monitoring Form (VAS pain, anxiety, fatigue and thirst scales)" were applied. The VAS scales contains numbers evenly spaced (0-10) on a line. It's an evaluation scale filled out by pregnants stating their current levels by givig a number. The cut off point of the VAS anxiety and thirst scales were found to be four.In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals. In VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms. The time of the last meal was learnt according to the information given by the pregnant woman. Spontaneous blood glucose measurement was performed. The labor diet was administered after 6 hours of fasting. Post-prandial blood glucose and tools were measured after the labor diet (at the 2nd hours)
| Study group | Role | What they receive |
|---|---|---|
| Experimental: This research is planned with experimental design | Experimental | The data collection tools "Personal Information Form", "Women's Perception of Supportive Care Provided at Birth Scale", and "Pregnant and Infant Monitoring Form (VAS pain, anxiety, fatigue and thirst scales)" were applied. The VAS scales contains numbers evenly spaced (0-10) on a line. It's an evaluation scale filled out by pregnants stating their current levels by givig a number. The cut off point of the VAS anxiety and thirst scales were found to be four.In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals. In VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms. The time of the last meal was learnt according to the information given by the pregnant woman. Spontaneous blood glucose measurement was performed in all pregnant women. Intermittent NST follow-up and routine medical treatment were continued. Receives: Dietary Supplement: Other: experimental group (labor diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety VAS (vizual scale)
Description: Change from anxiety scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's anxiety.
Measured: Time Frame: Anxiety scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Fatigue VAS (vizual scale)
Description: Change from fatigue scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's fatigue.
Measured: Time Frame: Fatigue scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Secondary outcomes (2)
Pain VAS (Vizual scale)
Description: Change from pain scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's pain.
Measured: Time Frame: Pain scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Thirst VAS (Vizual scale)
Description: Change from thirst scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's thirst.
Measured: Time Frame: Thirst scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start1 Feb 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Biruni 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
- Model description
- The study population consisted of all multiparous pregnant women admitted to the maternity unit of a state hospital on the European side of Istanbul between February and June 2022. Power analysis (G\*Power 3.1 program) was used to determine the sample. As a result of the analysis (with an effect size of 0.932, a confidence interval of 95%, and an error of 0.05), it was found that at least 47 pregnant women should be included in a group (12). Ninety-four pregnant women (experimental group:47; control group:47) were included in the sample.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nilgun Avci, Biruni University
- Investigators
- nilgün avcı, Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058168
- Sponsor's protocol ID
- 2015-KAEK-54-21-06
- Status last verified
- Jul 2025
- First submitted
- 13 Jun 2025
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Labor Diet Administered to Multiparous Pregnant Women on Mother and Baby During the Delivery Process
- ClinicalTrials.gov ID
- NCT07058168
- Acronym / sponsor ID
- 2015-KAEK-54-21-06
- Conditions
- Labor Pain, Labor, Diet
- Keywords
- labor, diet, labor diet, pregnant, delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 10 Jul 2025 (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 is a clinical trial. It aimed to examine the effects of the labor diet on pain, anxiety, fatigue, and thirst levels, maternal satisfaction during labor, in multiparous pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women with cervical dilatation less than 5 cm, and who were suitable for oral intake, and voluntarily accept to participate in the research were included in the study. Exclusion criteria from the study: Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; who could not speak or understand Turkish, who were under 18 years of age, who were primiparous, who were chronically ill and whose current pregnancy was risky. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours during labour. Pregnant women in the experimental group labor diet and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until labor. The main questions it aims to answer are: • Labor diet during labor; It is effective in reducing the level of pain. • Labor diet during labor; It is effective in reducing anxiety. • Labor diet during labor; It is effective in reducing thirst. • Labor diet during labor; It is effective in reducing fatigue. • Labor diet during labor; It is effective in increasing maternal satisfaction. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group labor diet also.
Detailed description
Objective: In this study, it was aimed to examine the effects of the labor diet on pain, anxiety, fatigue, and thirst levels, maternal satisfaction during labor, in multiparous pregnant women in the first stage of labor. Methods: The study was conducted in a randomized controlled experimental manner. The universe consisted of all pregnant women who applied to the delivery room of a public institution between February and June 2022. Power analysis was used to determine the sample. 94 pregnant women (47 experiments;47 controls) were included in the study. The study was started after the approval of the ethics committee and the institution. As a data collection tool in the research; "Personal Information Form","Women's Perception of Supportive Care Provided at Birth Scale" and "Pregnant and Infant Monitoring Form" were used.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study population consisted of all multiparous pregnant women admitted to the maternity unit of a state hospital on the European side of Istanbul between February and June 2022. Power analysis (G*Power 3.1 program) was used to determine the sample. As a result of the analysis (with an effect size of 0.932, a confidence interval of 95%, and an error of 0.05), it was found that at least 47 pregnant women should be included in a group (12). Ninety-four pregnant women (experimental group:47; control group:47) were included in the sample.
| Arm | Type | Receives |
|---|---|---|
| Experimental: This research is planned with experimental design | Experimental | Dietary Supplement: Other: experimental group (labor diet)The data collection tools "Personal Information Form", "Women's Perception of Supportive Care Provided at Birth Scale", and "Pregnant and Infant Monitoring Form (VAS pain, anxiety, fatigue and thirst scales)" were applied. The VAS scales contains numbers evenly spaced (0-10) on a line. It's an evaluation scale filled out by pregnants stating their current levels by givig a number. The cut off point of the VAS anxiety and thirst scales were found to be four.In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals. In VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms. The time of the last meal was learnt according to the information given by the pregnant woman. Spontaneous blood glucose measurement was performed in all pregnant women. Intermittent NST follow-up and routine medical treatment were continued. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Vaginal delivery,
- Who volunteered to participate in the research,
- Who with cervical dilatation less than 5 cm,
- who were suitable for oral intake
Key exclusion criteria (5 listed)
- Who could not speak or understand Turkish,
- Have auditory or mental health problems,
- Who were under 18 years of age,
- Who were primiparous,
- Who were chronically ill and whose current pregnancy was risky
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 |
|---|---|---|
| Other: experimental group (labor diet)The data collection tools "Personal Information Form", "Women's Perception of Supportive Care Provided at Birth Scale", and "Pregnant and Infant Monitoring Form (VAS pain, anxiety, fatigue and thirst scales)" were applied. The VAS scales contains numbers evenly spaced (0-10) on a line. It's an evaluation scale filled out by pregnants stating their current levels by givig a number. The cut off point of the VAS anxiety and thirst scales were found to be four.In VAS anxiety, scores above this cut-off point indicate deviation from normal and individuals must be handled by professionals. In VAS thirst, patients who score above this score are considered to be experiencing dehydration symptoms. The time of the last meal was learnt according to the information given by the pregnant woman. Spontaneous blood glucose measurement was performed. The labor diet was administered after 6 hours of fasting. Post-prandial blood glucose and tools were measured after the labor diet (at the 2nd hours) | Dietary supplement | Experimental: This research is planned with experimental design |
Primary outcome
Anxiety VAS (vizual scale)
Time frame: Time Frame: Anxiety scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Description: Change from anxiety scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's anxiety.
Fatigue VAS (vizual scale)
Time frame: Time Frame: Fatigue scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Description: Change from fatigue scale scores at control group or experimental group in during labor. The minimum score is 0 and the maximum score is 10. The higher the score, the greater the person's fatigue.
2 secondary outcomes
Pain VAS (Vizual scale)
Time frame: Time Frame: Pain scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
Thirst VAS (Vizual scale)
Time frame: Time Frame: Thirst scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.
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 10 Jul 2025.
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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.
nilgün avcı principal investigator
Biruni 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 Other: experimental group (labor diet) in people with Labor Pain and Labor, run by Biruni 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 4 inclusion and 5 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 10 Jul 2025. 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?
Anxiety VAS (vizual scale) (time frame: Time Frame: Anxiety scale used starting to labor diet. The delivery diet was administered according to the completion of the 6-hour fasting period. At 2 hours after the diet intake, the scale was repeated.). 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 10 Jul 2025.