ClinicalTrials.gg
RecruitingNCT06266819Updated Feb 20, 2024

The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum

An interventional study of chewing gum in Hyperemesis Gravidarum, sponsored by T.C. ORDU ÜNİVERSİTESİ. Recruiting at 1 site in Turkey. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-20.

Sponsored by T.C. ORDU ÜNİVERSİTESİ · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Primary completion was expected by Jun 2024, 2 years 5 months ago, but the record still lists the study as recruiting.
  • Started Jan 2024; still recruiting 2 years 9 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
78
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

In the research planned as a randomized controlled study, the experimental groups will be administered routine hyperemesis gravidarum (HG) treatment as well as chewing mint-flavored gum, while the control group will only receive routine HG treatment and no intervention will be performed. This study aims to contribute to the literature by investigating the effect of chewing mint-flavored gum on the severity of nausea and vomiting, coping with stress, and anxiety levels due to hyperemesis gravidarum in pregnant women.

Read the detailed description

The data of the research will be collected after the necessary institutional permission and ethics committee approval have been obtained. Women who meet the inclusion criteria for the study will be informed about the method to be followed in the research. Those who want to participate in the research will read and sign the volunteer information form.

  1. Intervention Group In data collection, pregnant women will sign an informed consent form before the application. Personal Information Form, VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled out. In addition to the routine treatment plan, the application will begin at least 4 hours after the antiemetic application (Gökbulut, 2021). The application will continue by chewing mint-flavored gum twice a day for at least 15 minutes for 3 days. The VAS scale will be filled after the morning chewing application, and the VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled in after the evening application. The forms of patients discharged during this period will be filled in via phone.
  2. Control Group In data collection, pregnant women will sign an informed consent form before the application. At least 4 hours after the antiemetic application (Gökbulut, 2021), the Personal Information Form, VAS Scale, PUQE Scale and Stress Coping Styles Scale and State Anxiety Scale will be filled out. Routine treatment and nursing care will be applied to the control group, and no intervention will be performed. 1. After the forms are applied, the forms will continue to be filled for 3 days: VAS Scale in the morning, VAS Scale in the evening, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale. The forms of discharged patients will be filled in via phone.
02

Conditions studied

  • Hyperemesis Gravidarum

Keywords

  • hyperemesis gravidarum
  • chewing gum
  • nausea and vomiting
  • mint
03

In context

Hyperemesis Gravidarum

40 studies on the registry are indexed under Hyperemesis Gravidarum; 6 are open to participants now.

This study's planned enrollment of 78 is close to the median of 84 across 24 interventional studies indexed under Hyperemesis Gravidarum.

Browse Hyperemesis Gravidarum studies →

Lead sponsor

T.C. ORDU ÜNİVERSİTESİ is the lead sponsor of 87 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Pregnant women aged 18 and over
  • At least primary school graduate
  • The one who is married
  • Pregnant women who are younger than 16 weeks of gestation and diagnosed with hyperemesis
  • Those who agreed to participate in the study

Exclusion criteria

Exclusion Criteria:

  • Those with a history of chronic disease
  • Having a health problem that may cause nausea and vomiting in the current pregnancy
  • Those who are allergic to mint
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
78 participants (estimated)

Study arms

  • Experimental
    the chewing of a mint-flavored gum group

    In data collection, pregnant women will sign an informed consent form before the application. Personal Information Form, VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled out. In addition to the routine treatment plan, the application will begin at least 4 hours after the antiemetic administration. The application will continue by chewing mint-flavored gum twice a day for at least 15 minutes for 3 days. The VAS scale will be filled after the morning chewing application, and the VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled in after the evening application. The forms of patients discharged during this period will be filled in via phone.

    Other: chewing gum

  • No intervention
    control group

    In data collection, pregnant women will sign an informed consent form before the application. At least 4 hours after the antiemetic administration, the Personal Information Form, VAS Scale, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale will be filled out. Routine treatment and nursing care will be applied to the control group, and no intervention will be performed. 1. After the forms are applied, the forms will continue to be filled for 3 days: VAS Scale in the morning, VAS Scale in the evening, PUQE Scale, Stress Coping Styles Scale and State Anxiety Scale. The forms of discharged patients will be filled in via phone.

Interventions

  • Otherchewing gum

    In addition to the routine treatment plan, mint-flavored gum will be chewed for an average of 15 minutes at least 4 hours after the antiemetic application.

06

What researchers measure

Primary outcomes

  1. Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24)

    It was developed to evaluate the severity of pregnancy-specific nausea and vomiting in the last 24 hours. Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) consists of 3 questions: "duration of nausea or stomach discomfort", "number of vomiting" and "number of retching". Answers to the questions are scored between 1-5 points. The total score of the scale is obtained by the sum of the scores of the answers given to the questions. The lowest score that can be obtained from the scale is 3 and the highest score is 15. If the total score obtained as a result of the PUQE-24 scoring system is 3-6, it is considered mild, 7-12 is considered moderate, and 13-15 is considered severe nausea and vomiting. The scale has no subdimensions. Cronbach's alpha value of the Turkish version of the scale is 0.75.

    Time frame: 8 hours

  2. Visual Analog Scale (VAS)

    It is used for pain assessment in musculoskeletal and other clinical evaluations. VAS is used to convert some values that cannot be measured numerically into numerical values. It is a frequently used measurement tool because it is easy to apply and safe. At the left end of the 10 cm long horizontal line are the words 'I have no pain' and at the right end the words 'I have pain'. The individual is told to mark the point on this horizontal line that best expresses the intensity of pain in his body. The distance of the point marked by the individual to the left end is measured and the pain score is determined. As the VAS value approaches 10, the intensity of the pain increases, and as it approaches 0, the intensity decreases. The lowest score from the scale is 0 and the highest score is 10.

    Time frame: 8 hours

Secondary outcomes

  1. Stress Coping Styles Scale (SCSS)

    Coping with Stress Coping Styles Scale is a four-point Likert type, consisting of 30 items and 5 subscales. Effective coping styles with stress are evaluated with the "Self-Confident Approach", "Optimistic Approach" and "Social Support Seeking Approach" sub-dimensions, while ineffective coping styles in coping with stress are evaluated with the "Helpless Approach" and "Submissive Approach" sub-dimensions. Higher scores indicate that the person uses more stress coping style. Cronbach Alpha Coefficients of the scale were found to be 0.78 for "Optimistic Approach", 0.83 for "Self-Security Approach", 0.90 for "Helpless Approach", 0.89 for "Submissive Approach" and 0.61 for "Seeking Social Support".

    Time frame: 8 hours

  2. State-Trait Anxiety Inventory (STAI)

    State-Trait Anxiety Inventory (STAI) determines how an individual feels at a certain moment and condition. STAI consists of 20 items and answers are answered according to the degree of intensity of emotions or behaviors as (1) not at all, (2) a little, (3) a lot, (4) completely. Items 1, 2, 5, 8, 10, 11, 15, 16, 19 and 20 in the scale are reverse scored. The STAI score is calculated by adding 50 points to the difference between the total weighted scores of direct statements and reverse statements. Scores between 20 and 80 can be obtained from STAI. If the score is below 36, it is considered that there is no anxiety, between 37 and 42 points, there is mild anxiety, and those with a score of 42 and above are considered to have high anxiety.

    Time frame: 8 hours

07

Study locations

1 of 1 sites recruiting
  • Özel Şar Hospital
    Rize, 53100, Turkey
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jan 2024 (actual). Primary completion is estimated for Jun 2024, 4 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 11, 2024
First posted
Feb 20, 2024
StartActual
Jan 15, 2024
Primary completionEst.
Jun 1, 2024
CompletionEst.
Jul 1, 2024
Last update
Feb 20, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 20, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06266819
Lead sponsor
T.C. ORDU ÜNİVERSİTESİ
Responsible party
Leyla Emirik (PhD Student, T.C. ORDU ÜNİVERSİTESİ) — Principal investigator
First posted
Feb 20, 2024
Start date
Jan 15, 2024
Primary completion
Jun 1, 2024 (estimated)
Completion
Jul 1, 2024 (estimated)
Last update
Feb 20, 2024

Study contacts

leyla emirik
Contact
leylayaguz@gmail.com
+90 5062848323

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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