Study Results
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Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2017-01-01
2018-01-01
Brief Summary
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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.
Detailed Description
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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. Patients with known psychiatric disorders, organic diseases causing nausea and vomiting, HG diagnosis in previous pregnancy and experience in hypnosis, meditation and mindfullness, and those who were multiparous or could not be cooperative with the treatment team were excluded from the study.
The patients were randomly assigned by means of picking closed envolopes to the Group H (GH) to receive hypnosis with conventional therapy and the Group C (GC) only to receive conventional therapy. Data on patient demographics, severity of nausea, numbers of vomiting per day, serum glucose, AST and ALT levels were recorded. 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).
Conventional Ttreatment The treatment in HG is targeted to minimise the symptoms in order to reduce the adverse outcomes for the mother and the foetus. In our study, the conventional treatment was organized according to symptom severity, the clinical findings and the response given to the treatment. The basic protocol for the first 24 hours included intravenous hydration for 6 hours with NaCl (0.9 % x1000 cc) supplemented with KCL, the B1 and B6 vitamins. Oral feeding was restricted and the second step treatment choice comprising H1 receptor blocker dimenhydrinate (4 X 50 mg/day, po) was routinely used in all patients. When the VAS score was ≥4, the serotonin antagonist ondansetron (4mg, i.v.) was added to the treatment as the rescue medication. The daily nausea, numbers of vomiting were queried on a daily basis. The patients with vomiting incidence below 2 per day, tolerating oral nutrition and with urine cleared of ketonuria met the conditions of discharge. The duration of hospital stay and treatment procedures were followed and recorded.
Hypnosis design Two sessions of hypnosis were carried out in addition to the conventional treatment on the first and second days of admission; and the paitents were instructed autohypnosis after the second session. This was repeated on the third day with the patients who could not satisfactorily acquire the technique and those who failed to succeed were excluded from the study. The GH included patients who carried out autohypnosis minimally 4 times per day.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Hypnosis group
Hypnosis is added to the conventional group.
Hypnosis
Hypnosis is added to the conventional group
conventional group
only conventional group
No interventions assigned to this group
Interventions
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Hypnosis
Hypnosis is added to the conventional group
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Turkiye Yuksek Ihtisas Education and Research Hospital
OTHER_GOV
Responsible Party
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Seyda Efsun Ozgunay
Assoc Prof
Principal Investigators
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Seyda E Ozgunay
Role: PRINCIPAL_INVESTIGATOR
Bursa Yuksek ihtisas research and training hospital
Burcu Cakmak
Role: PRINCIPAL_INVESTIGATOR
Bursa Yuksek ihtisas research and training hospital
Locations
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Bursa yuksek ihtisas eğitim araştırma hastanesi
Bursa, Yildirim/Bursa, Turkey (Türkiye)
Countries
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References
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Philip B. Hyperemesis gravidarum: literature review. WMJ. 2003;102(3):46-51.
Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.
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.
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.
Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
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.
Longo F, Mansueto G, Lapadula V, Stumbo L, Del Bene G, Adua D, De Filippis L, Bonizzoni E, Quadrini S. Combination of aprepitant, palonosetron and dexamethasone as antiemetic prophylaxis in lung cancer patients receiving multiple cycles of cisplatin-based chemotherapy. Int J Clin Pract. 2012 Aug;66(8):753-757. doi: 10.1111/j.1742-1241.2012.02969.x. Epub 2012 Jul 2.
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.
Other Identifiers
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66519339-900-01/2015/02-04
Identifier Type: -
Identifier Source: org_study_id