Pregnancy Related Clinical Trial
Official title:
The Effect of Band-Aid Applied to the Umbilical Area on Nausea and Vomiting During Pregnancy
NCT number | NCT05788796 |
Other study ID # | 13.03.2023 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 15, 2023 |
Est. completion date | June 5, 2024 |
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.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | June 5, 2024 |
Est. primary completion date | May 15, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - 18 years and over, - 5-14 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. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
Turkey | Yeni Yali Aile Sagligi Merkezi | Kocaeli | Kocaeli? |
Lead Sponsor | Collaborator |
---|---|
Sakarya University |
Turkey,
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05017974 -
Research on Improving Sleep During Pregnancy
|
N/A | |
Completed |
NCT03284515 -
Vaccination In Pregnancy Gene Signature: VIP Signature Study
|
||
Recruiting |
NCT05969795 -
Comparison of Live Birth Rate in Natural Cycle Single Euploid FET Versus Without Luteal Phase Support
|
Phase 1 | |
Recruiting |
NCT06051201 -
Innovation for Small-scale Experiments: ReceptIVFity Test
|
N/A | |
Recruiting |
NCT04828382 -
Prospective Study of Pregnancy in Women With Cystic Fibrosis
|
||
Enrolling by invitation |
NCT04527926 -
STEPuP: Prenatal Provider Education and Training to Improve Medication-assisted Treatment Use During Pregnancy
|
N/A | |
Recruiting |
NCT04278651 -
Early Antenatal Support for Iron Deficiency Anemia
|
Phase 4 | |
Recruiting |
NCT04405700 -
Measuring Adverse Pregnancy and Newborn Congenital Outcomes
|
||
Recruiting |
NCT06258902 -
Odevixibat Pregnancy and Lactation Surveillance Program: A Study to Evaluate the Safety of Odevixibat During Pregnancy and/or Lactation
|
||
Completed |
NCT05487196 -
Effectiveness of Clonidine, Dexmedetomidine, and Fentanyl Adjuncts for Labor Epidural Analgesia
|
Phase 2 | |
Completed |
NCT03750968 -
Lutein & Zeaxanthin in Pregnancy - Carotenoid Supplementation During Pregnancy: Ocular and Systemic Effects
|
Phase 2 | |
Enrolling by invitation |
NCT06127277 -
Next4You: A Fully Mobile Relationships Based Program for Youth in Foster Care
|
N/A | |
Completed |
NCT05897697 -
Assessing Women's Preferences for Postpartum Thromboprophylaxis: the Prefer-Postpartum Study
|
||
Recruiting |
NCT05899101 -
The Impact of Opioid and Cannabis Exposure on Fetal Growth
|
||
Completed |
NCT05502510 -
Assessing the Effectiveness and Efficacy of the MyHealthyPregnancy Application
|
||
Completed |
NCT04296396 -
Opioid Prescription After Cesarean Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069869 -
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06069856 -
Multiple Micronutrient Supplementation (MMS) IFA- Iron Dose Acceptability Crossover Trial
|
Phase 3 | |
Not yet recruiting |
NCT06079918 -
Multiple Micronutrient Supplementation for Maternal Anemia Prevention in Tanzania
|
Phase 3 | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A |