The Effect of Plaster on Nausea-Vomiting During Pregnancy

NCT05788796 | Completed

• 1 other identifier: 13.03.2023
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Hormonal and physical changes during pregnancy can cause nausea and vomiting. Nausea and vomiting are common, especially in the first trimester. The incidence of nausea and vomiting during pregnancy varies between 50% and 80%. Symptoms range from mild nausea to excessive vomiting, dehydration, electrolyte imbalances, and weight loss to a severe form of nausea-vomiting called hyperemesis gravidarum (HG). Nausea-vomiting can cause discomfort in the pregnant woman in its mildest form, and a serious threat to the life of the mother and fetus in the most severe form. Nausea and vomiting during pregnancy is an important symptom that reduces the quality of life of the pregnant woman.In order to reduce the complaints of nausea and vomiting during pregnancy, women are offered suggestions such as changing their eating habits and staying away from stress. Complementary and alternative methods can also be used to reduce nausea and vomiting. Acupressure, which is one of these methods, is accepted as an important, effective, supportive and economical complementary method as a non-invasive technique that midwives can directly include in the control of nausea and vomiting during pregnancy, reducing the severity of labor pain, accelerating the birth process, gynecological problems and assisting breastfeeding. The efficacy of acupressure applied to P6, ST36 and CV8 points in cases of nausea and vomiting experienced after motion sickness, chemotherapy or surgery has been investigated in many studies. The CV8 point has not been studied sufficiently in reducing nausea and vomiting in pregnancy. Therefore, the aim of this study is to investigate the effect of a band-aid applied to the umbilical area (Shenque-CV8 point), which is a method that pregnant women can apply on their own, on nausea-vomiting during pregnancy.The sample of the study will consist of 60 pregnant women, 30 in the application group and 30 in the control group. Which of the application/control groups of the pregnant women constituting the sample group will be included will be determined by simple randomization. Pregnant women in the treatment group will be asked to fix a hazelnut-sized cotton ball to their navel with a Band-Aid regularly for five days before going to bed at night. Pregnant women in the control group will not be asked to make any life changes. Five days later, the nausea-vomiting levels of the pregnant women who applied and the pregnant women in the control group will be compared.

Conditions

Nausea Gravidarum; Vomiting of Pregnancy; Pregnancy Related; Acupressure

Keywords

Pregnancy; Nausea; Vomiting; Acupressure

Outcome Measures

Primary Outcomes (2)

• Rhodes Nausea and Vomiting Index

  The Rhodes Nausea and Vomiting Index rating system is a five-point Likert type, with the lowest possible score being "8" and the highest score being "40". Those who score 8 or below in the RBMI are evaluated as "No Symptom", those between 9-18 points as "Mild Symptom", those between 19-32 points as "Moderate Symptom" and those between 32-40 points as "Severe/Severe Symptom".

  time frame : 5 days

• Pregnancy Nausea-Vomiting Severity Evaluation Test (PUQE)

  There are 3 questions in the PUQE test that examine nausea, vomiting and retching, respectively. Although symptoms were initially questioned for the last 12 hours, they were later updated to include the last 24 hours (104). In the study conducted by Sucu et al. on pregnant women in Turkey, they stated that the PUQE test is a suitable tool for evaluating the severity of nausea and vomiting during pregnancy. When evaluating the PUQE test, a total score of 3-6 is indicated as mild, 7-12 as moderate, and 13-15 as severe nausea and vomiting.

  time frame : 5 days

Study Arms (2)

Experimental: Experimental group

EXPERIMENTAL

Experimental:Pregnant women in the application group will be asked to take a hazelnut-sized cotton ball before going to bed, put it in the middle of the navel and close it diagonally with a band-aid.

Behavioral: Band-aid application

Assigned Interventions

NO INTERVENTION

No Intervention: Control group Pregnant women in the control group will be asked not to make any lifestyle changes and to continue their routine daily lives.

Interventions

Band-aid application BEHAVIORAL

Before starting the study, cotton and band-aids will be provided to the women in the application group by the researchers. • Pregnant women in the application group will be asked to take a hazelnut-sized cotton ball before going to bed, put it in the middle of the navel and close it diagonally with a band-aid.

Experimental: Experimental group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years and over,
• weeks pregnant,
• Volunteer to participate in the research
• Having nausea and vomiting during pregnancy,
• Not allergic to any drug or product, literate,
• Can speak and understand Turkish
• Pregnant women who did not receive hyperemesis gravidarum treatment will be included.

You may not qualify if:

• pregnant over 14 weeks,
• low risk in pregnancy,
• with chronic disease,
• Having multiple pregnancies.
• In order to ensure the follow-up of the application of the women, the researchers will be in constant communication with the women and will check whether they have applied the Band-Aid.
• Women who do not perform the application although they are in the application group will be excluded from the study.

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Yeni Yalı Aile Sağlığı Merkezi

Köseköy, Kocaeli, Turkey (Türkiye)

Location

Related Publications (4)

• Laitinen L, Nurmi M, Ellila P, Rautava P, Koivisto M, Polo-Kantola P. Nausea and vomiting of pregnancy: associations with personal history of nausea and affected relatives. Arch Gynecol Obstet. 2020 Oct;302(4):947-955. doi: 10.1007/s00404-020-05683-3. Epub 2020 Jul 11.

  PMID: 32653947 BACKGROUND

• Einarson TR, Piwko C, Koren G. Prevalence of nausea and vomiting of pregnancy in the USA: a meta analysis. J Popul Ther Clin Pharmacol. 2013;20(2):e163-70. Epub 2013 Jul 14.

  PMID: 23863545 BACKGROUND

• Yu S, Wen Y, Xia W, Yang M, Lv Z, Li X, Li W, Yang S, Hu Y, Liang F, Yang J. Acupoint herbal plaster for patients with primary dysmenorrhea: study protocol for a randomized controlled trial. Trials. 2018 Jul 3;19(1):348. doi: 10.1186/s13063-018-2682-8.

  PMID: 29970155 BACKGROUND

• Viljoen E, Visser J, Koen N, Musekiwa A. A systematic review and meta-analysis of the effect and safety of ginger in the treatment of pregnancy-associated nausea and vomiting. Nutr J. 2014 Mar 19;13:20. doi: 10.1186/1475-2891-13-20.

  PMID: 24642205 BACKGROUND

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Yasemin Hamlacı Başkaya

  Sakarya University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Since there is no placebo group, masking will not be done.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: : Head of Midwifery Depatment

Model Details: Pregnant women in the application group will be asked to take a hazelnut-sized cotton ball before going to bed, put it in the middle of the navel and close it diagonally with a band-aid. Pregnant women in the control group will be asked not to make any lifestyle changes and to continue their routine daily lives.

Study Record Dates

• First Submitted: March 15, 2023
• First Posted: March 29, 2023
• Study Start: May 15, 2023
• Primary Completion: May 15, 2024
• Study Completion: June 15, 2024
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)