Labor Pain and AnxietyTEMFCGPADAPLNCT07801196
Effects of Mint-Flavored Chewing Gum on Childbirth
A study testing Routine midwifery care and Mint Chewing Gum During Labor in people with Labor Pain and Anxiety, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain and Anxiety
- What is being tested?
- Routine midwifery care and Mint Chewing Gum During Labor
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Oct 2025to 24 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University Faculty of Health Sciences
Istanbul
About this study
Official title: The Effect of Mint-Flavored Chewing Gum on Pain and Anxiety During the Active Phase of Labor
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.
Read the detailed description
Objective: Managing pain and anxiety during childbirth is important for the health of the mother and baby, as well as for the positive birth experience. Midwives support women in coping with pain and anxiety during the birth process by utilizing non-pharmacological methods. The aim of this study is to investigate the effect of chewing mint gum during labor on the birth pain and state anxiety levels of primiparous pregnant women.
Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 106 primiparous pregnant women who were in the process of labor and met the inclusion criteria of the study. The participants were divided into two groups: 53 in the intervention group and 53 in the control group. Pregnant women in the intervention group were made to chew mint-flavored sugar-free gum for at least 20 minutes during labor, while routine midwifery care was applied to pregnant women in the control group. In both groups, birth pain and state anxiety levels were evaluated. The measurements were taken during the 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatation periods of labor.
- Conditions
- Labor Pain and Anxiety
- Being tested
- Routine midwifery care, Mint Chewing Gum During Labor
- Keywords
- chewing mint gum, labor pain, anxiety, labor, primiparous pregnant women
- Medical subject headings
- Labor Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine midwifery careOther
Only midwifery services were provided to pregnant women in the control group.
Mint Chewing Gum During LaborOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Mint Chewing Gum During Labor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.
Secondary outcomes (1)
State Anxiety Scale
The State Anxiety Scale (SAS) is used to assess the level of state anxiety experienced by individuals. The scale consists of 20 items, with each item scored on a 4-point Likert scale. Total scores range from 20 to 80, with higher scores indicating higher levels of state anxiety.
Measured: During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start9 Oct 2025
- Primary completion24 Feb 2026
- Study completion24 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Labor Pain and AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tuğba YILMAZ ESENCAN, Uskudar University
- Investigators
- Tuğba Yılmaz Esencan, associate professor doctor, Study director, Uskudar Universityeylem gezer, specialist midwife, Principal investigator, Mazıdağı State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07801196
- Sponsor's protocol ID
- 2025-12
- Acronym
- TEMFCGPADAPL
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study will be published in Yöktez.
Publications
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.
PubMed 35045813Mohsenzadeh-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.
PubMed 40322058
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mint-Flavored Chewing Gum on Pain and Anxiety During the Active Phase of Labor
- ClinicalTrials.gov ID
- NCT07801196
- Acronym / sponsor ID
- TEMFCGPADAPL / 2025-12
- Conditions
- Labor Pain and Anxiety
- Keywords
- chewing mint gum, labor pain, anxiety, labor, primiparous pregnant women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 24 Feb 2026 (actual)
- Study completion
- 24 Feb 2026 (actual)
- First posted
- 3 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objective: Managing pain and anxiety during childbirth is important for the health of the mother and baby, as well as for the positive birth experience. Midwives support women in coping with pain and anxiety during the birth process by utilizing non-pharmacological methods. The aim of this study is to investigate the effect of chewing mint gum during labor on the birth pain and state anxiety levels of primiparous pregnant women.
Materials and Methods: The research was conducted in a randomized controlled experimental design. The sample of the study consisted of 106 primiparous pregnant women who were in the process of labor and met the inclusion criteria of the study. The participants were divided into two groups: 53 in the intervention group and 53 in the control group. Pregnant women in the intervention group were made to chew mint-flavored sugar-free gum for at least 20 minutes during labor, while routine midwifery care was applied to pregnant women in the control group. In both groups, birth pain and state anxiety levels were evaluated. The measurements were taken during the 4-5 cm, 6-7 cm, and 8-9 cm cervical dilatation periods of labor.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| control group | Sham comparator | Other: Routine midwifery carePregnant women in the control group received routine midwifery care during childbirth and did not receive the mint gum chewing intervention. |
| min chewing gum group | Active comparator | Other: Mint Chewing Gum During Laborparticipants in this group received mint chewing gum during labor according to the study protocol |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine midwifery careOnly midwifery services were provided to pregnant women in the control group. | Other | control group |
| Mint Chewing Gum During LaborParticipants 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. | Other | min chewing gum group |
Primary outcome
The Angle Labor Pain Scale
Time frame: During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.
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.
1 secondary outcome
State Anxiety Scale
Time frame: During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Results publication: PubMed 35045813Ebrahimian 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.
- Results publication: PubMed 40322058Mohsenzadeh-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.
- Doğum Ağrısı ÖlçeğiLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study will be published in Yöktez.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tuğba Yılmaz Esencan, associate professor doctor study director
Uskudar University
eylem gezer, specialist midwife principal investigator
Mazıdağı State Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine midwifery care and Mint Chewing Gum During Labor in people with Labor Pain and Anxiety, run by Uskudar University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Angle Labor Pain Scale (time frame: During active labor, when cervical dilation reaches 4-5 cm, 6-7 cm, and 8-9 cm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07801196, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.