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

February 11, 2024 updated by: Leyla Emirik, T.C. ORDU ÜNİVERSİTESİ

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Rize, Turkey, 53100
        • Recruiting
        • Özel Şar Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 hours
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.
8 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stress Coping Styles Scale (SCSS)
Time Frame: 8 hours
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".
8 hours
State-Trait Anxiety Inventory (STAI)
Time Frame: 8 hours
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.
8 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

T.C. ORDU ÜNİVERSİTESİ

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 15, 2024

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

February 11, 2024

First Submitted That Met QC Criteria

February 11, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 11, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OU-HEM-LE-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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