The Effect of Labor Diet During the Delivery Process

NCT ID: NCT07058168

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2022-06-30

Brief Summary

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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

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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

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Labor Pain Labor Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Experimental: This research is planned with experimental design

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.

Group Type EXPERIMENTAL

Other: experimental group (labor diet)

Intervention Type 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)

Interventions

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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)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Biruni University

OTHER

Sponsor Role lead

Responsible Party

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Nilgun Avci

Biruni Unşversity

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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nilgün avcı

Role: PRINCIPAL_INVESTIGATOR

Biruni University

Locations

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Biruni University

Zeytinburnu, Istanbul, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2015-KAEK-54-21-06

Identifier Type: -

Identifier Source: org_study_id

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