NCT07801196

Brief Summary

This study aims to examine the effect of chewing mint-flavored gum during childbirth on labor pain and anxiety levels. Chewing mint-flavored gum is a non-pharmacological method used during childbirth, and it is believed that it can help women cope with pain and anxiety during childbirth.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

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

October 9, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
Last Updated

September 3, 2026

Status Verified

August 1, 2026

Enrollment Period

5 months

First QC Date

August 28, 2026

Last Update Submit

September 2, 2026

Conditions

Keywords

chewing mint gumlabor painanxietylaborprimiparous pregnant women

Outcome Measures

Primary Outcomes (1)

  • The Angle Labor Pain Scale

    The Angle Labor Pain Scale (A-LPQ) was developed by Angle et al. to assess the pain experienced by women during labor. The scale consists of 22 items, each scored from 0 to 10. The total score ranges from 0 to 220, with higher scores indicating greater perceived labor pain.

    During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.

Secondary Outcomes (1)

  • State Anxiety Scale

    During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.

Study Arms (2)

control group

SHAM COMPARATOR

Pregnant women in the control group received routine midwifery care during childbirth and did not receive the mint gum chewing intervention.

Other: Routine midwifery care

min chewing gum group

ACTIVE COMPARATOR

participants in this group received mint chewing gum during labor according to the study protocol

Other: Mint Chewing Gum During Labor

Interventions

Only midwifery services were provided to pregnant women in the control group.

control group

Participants in the intervention group chewed mint-flavored sugar-free gum for at least 20 minutes during childbirth. The intervention was performed in 4-5 cm, 6-7 cm and 8-9 cm cervical dilatations. Pain and anxiety levels were evaluated at each stage.

min chewing gum group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe study was conducted on pregnant women who were about to give birth for the first time.
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • being over the age of 18 and primiparous, There is no risk for vaginal birth, Without communication problems, Pregnant women without systemic or chronic diseases, Pregnant women with cervical dilatation of 4 cm or more, 37. The pregnancy is at term and a singleton pregnancy. Pregnant women who can chew gum without a history of dental, maxillofacial surgery, or dental disease will be included in the study.

You may not qualify if:

  • Pregnant women who do not like chewing gum, Pregnant women with mental and auditory health problems, Pregnant women with mint allergies, Pregnant women with dental or jaw problems, High-risk pregnancies will not be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uskudar University Faculty of Health Sciences

Istanbul, Turkey (Türkiye)

Location

Related Publications (2)

  • Ebrahimian A, Bilandi RR, Bilandi MRR, Sabzeh Z. Comparison of the effectiveness of virtual reality and chewing mint gum on labor pain and anxiety: a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Jan 19;22(1):49. doi: 10.1186/s12884-021-04359-3.

  • Mohsenzadeh-Ledari F, Omidvar S, Ghanbarpour A, Behmanesh F, Gholinia Ahangar H. The Effect of Chewing Gum in Managing Labor Pain Intensity and Anxiety Level in Primiparous Women: A Randomized Controlled Trial. Int J Community Based Nurs Midwifery. 2025 Apr 1;13(2):103-112. doi: 10.30476/ijcbnm.2025.102876.2515. eCollection 2025 Apr.

Related Links

MeSH Terms

Conditions

Labor PainAnxiety Disorders

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Tuğba Yılmaz Esencan, associate professor doctor

    Uskudar University

    STUDY DIRECTOR
  • eylem gezer, specialist midwife

    Mazıdağı State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: The researcher will provide the gumdrops to be used in the intervention group. For each pregnant woman in the intervention group, the specified amount of mint-flavored sugar-free gum will be used according to the established protocol. Pregnant women in the intervention group will be asked to chew gum during the cervical dilation stages(5-6 cm, 6-7 cm and 8-9 cm) determined during the active phase of labor. The gum chewing process will be monitored through the Gum Chewing Monitoring Form, and information regarding the application will be recorded in the form. At the same time, the birth process will be monitored through routine midwifery care provided by the researcher midwife throughout the progression of labor. Details of the gum chewing application and information regarding the application process will be recorded.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor doctor

Study Record Dates

First Submitted

August 28, 2026

First Posted

September 3, 2026

Study Start

October 9, 2025

Primary Completion

February 24, 2026

Study Completion

February 24, 2026

Last Updated

September 3, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will share

The study will be published in Yöktez.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
The work began on October 9, 2025 and ended on February 24, 2026.
Access Criteria
The study can be accessed by entering Yöktez and typing the name of the study or the names of the administrators.
More information

Locations