Clinical trial NCT06266819: The Effect of Mint Flavored Chewing Gum on Hyperemesis Gravidarum Nausea Vomiting Severity, Coping With Stress and Anxiety Level in Pregnants With Hyperemesis Gravidarum
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hyperemesis Gravidarum
Keywords: hyperemesis gravidarum
chewing gum
nausea and vomiting
mint
Lead sponsor: T.C. ORDU ÜNİVERSİTESİ
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 78
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups with chewing mint gum experimental group and a control group
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pregnancy-Specific Nausea and Vomiting Severity Scale (PUQE-24)
timeFrame: 8 hours
measure: Visual Analog Scale (VAS)
timeFrame: 8 hours
Secondary outcomes:
measure: Stress Coping Styles Scale (SCSS)
timeFrame: 8 hours
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: 8 hours
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Özel Şar Hospital
Study officials:
References: