Alternative Method: Chewing Gum in Labor

NCT06959940 | Completed

• 1 other identifier: Chewing gum in labor
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Labor Pain

Keywords

Labor; gum; pain; anxiety; fatigue; thirst

Outcome Measures

Primary Outcomes (4)

• 2

  Change from anxiety scale scores at control group or experimental group in during labor

  Anxiety scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

• 1

  Change from pain scale scores at control group or experimental group in during labor

  Pain scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

• 3

  Change from fatigue scale scores at control group or experimental group in during labor

  Fatigue scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

• 4

  Change from thirst scale scores at control group or experimental group in during labor

  Thirst scale used starting to chew gum. Then after chewing gum (immediately after the intervention), the scale was repeated. The score on the scale is between 0-10, just like the VAS (visual analogue pain scale). The higher score is the greater problem.

Study Arms (1)

This research is planned with experimental design

EXPERIMENTAL

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.

Other: experimental group (gum group)

Interventions

experimental group (gum group) 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.

This research is planned with experimental design

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Biruni University: lead

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Labor Pain; Pain; Anxiety Disorders; Fatigue

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, PhD

Model Details: 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).

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: May 7, 2025
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: May 7, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

TU (1)