Hyperemesis GravidarumNCT06266819
The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum
A study testing chewing gum in people with Hyperemesis Gravidarum, run by Ordu University at 1 site in Turkey (Türkiye).
Trial 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. 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
- Hyperemesis Gravidarum
- What is being tested?
- chewing gum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 1 Jul 2024
- 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
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Özel Şar Hospital
Rize, 53100
M.Akif KUMBUZOĞLU, Uzm. Dr., +90 464 212 11 03, info@sarhospital.com.tr
About this study
Official title: The Effect of Mint Flavored Chewing Gum Application on Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum
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.
- 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.
- 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.
- Conditions
- Hyperemesis Gravidarum
- Being tested
- chewing gum
- Keywords
- hyperemesis gravidarum, chewing gum, nausea and vomiting, mint
- Medical subject headings
- Hyperemesis Gravidarum, Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing gumOther
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.
| Study group | Role | What they receive |
|---|---|---|
| the chewing of a mint-flavored gum group | Experimental | 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. Receives: Other: chewing gum |
| control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours
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.
Measured: 8 hours
Secondary outcomes (2)
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".
Measured: 8 hours
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.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start15 Jan 2024
- Primary completion1 Jun 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperemesis GravidarumStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two groups with chewing mint gum experimental group and a control group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ordu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leyla Emirik, Ordu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06266819
- Sponsor's protocol ID
- OU-HEM-LE-01
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mint Flavored Chewing Gum Application on Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum
- ClinicalTrials.gov ID
- NCT06266819
- Acronym / sponsor ID
- OU-HEM-LE-01
- Conditions
- Hyperemesis Gravidarum
- Keywords
- hyperemesis gravidarum, chewing gum, nausea and vomiting, mint
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Ordu UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 20 Feb 2024 (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.
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.
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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- two groups with chewing mint gum experimental group and a control group
| Arm | Type | Receives |
|---|---|---|
| the chewing of a mint-flavored gum group | Experimental | Other: chewing gumIn 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
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 |
|---|---|---|
| chewing gumIn 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. | Other | the chewing of a mint-flavored gum group |
Primary outcome
Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24)
Time frame: 8 hours
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.
Visual Analog Scale (VAS)
Time frame: 8 hours
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.
2 secondary outcomes
Stress Coping Styles Scale (SCSS)
Time frame: 8 hours
State-Trait Anxiety Inventory (STAI)
Time frame: 8 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing gum in people with Hyperemesis Gravidarum, run by Ordu 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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact leyla emirik (+90 5062848323, leylayaguz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24) (time frame: 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Feb 2024.