Alternative Method: Chewing Gum in Labor

NCT ID: NCT06959940

Last Updated: 2025-05-07

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

2022-04-01

Study Completion Date

2022-11-30

Brief Summary

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This study is a clinical trial. It aimed to examine the effects of chewing gum on pain, anxiety, fatigue, and thirst in pregnant women (47 experiments; 47 controls) in the first stage of labor. Criteria for inclusion in the study: Pregnant women who gave birth vaginally; voluntarily accept to participate in the research. Exclusion criteria from the study: Pregnant women who have auditory or mental health problems; whose baby dies during labor, who with cervical dilatation of 5 cm or more, who receiving epidural anesthesia, do not like chewing gum, have difficulty chewing, such as weak/loose-fitting dentures. The pain, anxiety, fatigue, and thirst levels of the pregnant women in the control group were evaluated with scales every two hours until their dilatation reached 5 cm. Pregnant women in the experimental group chewed gum and their pain, anxiety, fatigue and thirst levels were evaluated with scales every two hours until their dilation reached 5 cm.

The main questions it aims to answer are:

* Chewing gum during labor is not effective in reducing pain, anxiety, fatigue, and thirst levels.
* Chewing gum during labor; It is effective in reducing the level of pain.
* Chewing gum during labor; It is effective in reducing anxiety.
* Chewing gum during labor; It is effective in reducing thirst.
* Chewing gum during labor; It is effective in reducing fatigue. Routine medical treatment of pregnant women continued all groups. Only pregnant women who in the experimental group chewed gum also.

Detailed Description

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Objective: In this study, it was aimed to examine the effects of chewing gum on pain, anxiety, fatigue and thirst in pregnant women in the first stage of normal 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 April and November 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","Gum Chewing Follow-up Form" and "Pregnant Follow-up Form" were used.

Conditions

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Labor Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Power analysis was used to determine the sample. The power of the test was calculated with the G\*Power 3.1 program. The effect size in the interventional study conducted by Gundogdu (2019) on pregnant women was based on 0.932. In order to exceed the 95% value in determining the power of the study, it was determined that 94 people, including at least 47 people in the groups, should be reached the 5% significance level and 0.95 effect size (df=0.75; t=1.676).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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This research is planned with experimental design

After the pregnant woman in the control group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied. Pregnancy Follow-up Form consists of pain, anxiety, fatigue and thirst scales. The VAS pain, anxiety, fatigue, and thirst scales contains numbers evenly spaced (0-10) on a line. It is an evaluation scale filled out by patients stating their current pain, anxiety, fatigue, and thirst level by giving 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.

Group Type EXPERIMENTAL

experimental group (gum group)

Intervention Type OTHER

After the pregnant woman in the experimental group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied. Pregnant women who agreed to participate in the study were given information about chewing gum. Pain, anxiety, fatigue and thirst scales were administered to the pregnant woman before she started chewing gum. The pregnant woman was allowed to chew gum for 15 minutes. At the end of 15 minutes, the measurements were repeated. Applications were repeated as stated above every two hours until the pregnant woman's dilation reached 5 cm. Routine medical treatment of pregnant women continued.

Interventions

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experimental group (gum group)

After the pregnant woman in the experimental group was admitted to the delivery room, the data collection tools "Personal Information Form" and "Pregnant Follow-up Form" were applied. Pregnant women who agreed to participate in the study were given information about chewing gum. Pain, anxiety, fatigue and thirst scales were administered to the pregnant woman before she started chewing gum. The pregnant woman was allowed to chew gum for 15 minutes. At the end of 15 minutes, the measurements were repeated. Applications were repeated as stated above every two hours until the pregnant woman's dilation reached 5 cm. Routine medical treatment of pregnant women continued.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Vaginal delivery,
* Who volunteered to participate in the research

Exclusion Criteria

* Have auditory or mental health problems,
* The baby dies during labour,
* Cervical dilatation of 5 cm or more,
* Receiving epidural anaesthesia,
* People who don't like chewing gum,
* Chewing difficulties due to weak/loose prostheses
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

Assistant professor, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Biruni University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Chewing gum in labor

Identifier Type: -

Identifier Source: org_study_id

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