NCT07058168

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2025

Completed
27 days until next milestone

First Posted

Study publicly available on registry

July 10, 2025

Completed
Last Updated

July 10, 2025

Status Verified

July 1, 2025

Enrollment Period

5 months

First QC Date

June 13, 2025

Last Update Submit

July 9, 2025

Conditions

Keywords

labordietlabor dietpregnantdelivery

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    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)

    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: 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.

Study Arms (1)

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.

Dietary Supplement: Other: experimental group (labor diet)

Interventions

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)

Experimental: This research is planned with experimental design

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Vaginal delivery,
  • Who volunteered to participate in the research,
  • Who with cervical dilatation less than 5 cm,
  • who were suitable for oral intake

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Zeytinburnu, Istanbul, 34010, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • nilgün avcı

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Biruni Unşversity

Study Record Dates

First Submitted

June 13, 2025

First Posted

July 10, 2025

Study Start

February 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

July 10, 2025

Record last verified: 2025-07

Locations