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

NCT ID: NCT06266819

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-07-01

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.

Conditions

Hyperemesis Gravidarum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

chewing gum

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ordu University

OTHER

Sponsor Role: lead

Responsible Party

Leyla Emirik

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Özel Şar Hospital

Rize, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

leyla emirik

Role: CONTACT

leylayaguz@gmail.com

+90 5062848323

Facility Contacts

M.Akif KUMBUZOĞLU, Uzm. Dr.

Role: primary

info@sarhospital.com.tr

+90 464 212 11 03

Other Identifiers

OU-HEM-LE-01

Identifier Type: -

Identifier Source: org_study_id