Nausea Clinical Trial
Official title:
The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum: A Prospective Randomized Study
Verified date | November 2023 |
Source | Turkiye Yuksek Ihtisas Education and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Aim: It has been aimed in this study to investigate the effects of hypnosis used to augment the conventional therapy on nausea, vomiting, rescue drug consumption and hospital stay in cases of Hyperemesis Gravidarum (HG). Methods: This prospective randomised study was carried out with 41 inpatients diagnosed with HG. The patients were grouped as GH (n=18) given hypnosis and GC (n=23) not given hypnosis with the conventional therapy. Group H were hypnotized during two sessions and taught auto-hypnosis. Data on the patient demographics, VAS scores for severity of nausea, the numbers of vomiting per day, additional medications used and the days of hospital stay were recorded.
Status | Completed |
Enrollment | 41 |
Est. completion date | January 1, 2018 |
Est. primary completion date | January 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Pregnant patients above the age of 18 years, admitted to the hospital with HG diagnosis were included in the study. HG was diagnosed on the basis of having at least one of the symptoms of ketonuria, weight loss in excess of 5% of the body weight and serious vomiting more than twice per day. Exclusion Criteria: - Patients with known psychiatric disorders, organic diseases causing nausea and vomiting, HG diagnosis in previous pregnancy and experience in hypnosis, meditation and mindfulness, and those who were multiparous or could not be cooperative with the treatment team were excluded from the study. |
Country | Name | City | State |
---|---|---|---|
Turkey | Bursa yuksek ihtisas egitim arastirma hastanesi | Bursa | Yildirim/Bursa |
Lead Sponsor | Collaborator |
---|---|
Turkiye Yuksek Ihtisas Education and Research Hospital |
Turkey,
Emami-Sahebi A, Elyasi F, Yazdani-Charati J, Shahhosseini Z. Psychological interventions for nausea and vomiting of pregnancy: A systematic review. Taiwan J Obstet Gynecol. 2018 Oct;57(5):644-649. doi: 10.1016/j.tjog.2018.08.005. — View Citation
Ergin M, Cendek BD, Neselioglu S, Avsar AF, Erel O. Dynamic thiol-disulfide homeostasis in hyperemesis gravidarum. J Perinatol. 2015 Oct;35(10):788-92. doi: 10.1038/jp.2015.81. Epub 2015 Jul 9. — View Citation
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Tan PC, Omar SZ. Contemporary approaches to hyperemesis during pregnancy. Curr Opin Obstet Gynecol. 2011 Apr;23(2):87-93. doi: 10.1097/GCO.0b013e328342d208. — View Citation
Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84. — View Citation
Werner A, Uldbjerg N, Zachariae R, Nohr EA. Effect of self-hypnosis on duration of labor and maternal and neonatal outcomes: a randomized controlled trial. Acta Obstet Gynecol Scand. 2013 Jul;92(7):816-23. doi: 10.1111/aogs.12141. Epub 2013 Apr 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Effect of Adjuvant Hypnosis on Nausea and Vomiting in Hyperemesis Gravidarum | Data on severity of nausea, numbers of vomiting per day were recorded. Deducting the score at discharge from the score at arrival indicated the decrease in the VAS score during treatment. Nausea and vomiting severity were evaluated 4 times per day using the Visual Analog Scale (VAS 0-10; with 0=no nausea and10=extreme nausea). | baseline + 12 months | |
Secondary | The effect of hypnosis on hospital stay | To obtain data on the severity of nausea, the daily number of vomiting. To determine the difference between VAS value during discharge and VAS ariviing hospitalization. Nausea and vomiting severity were evaluated 4 times a day using theVisual Analogue Scale (VAS 0-10; 0 = no nausea and 10 = excessive nausea). | baseline + 12 months |
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