Use of Hypnosis in Hyperemesis Gravidarum

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04828967
• Other study ID #: 66519339-900-01/2015/02-04
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: November 2023
• Source: Turkiye Yuksek Ihtisas Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

This prospective, randomised and single blind study, with the physician follow up the patients for nausea and vomiting not informed on the grouping of the patients, was carried out at a single center between January 2017 and January 2018. The study protocol was approved by the local Ethics Committee was conducted in accordance with the principles of the Declaration of Helsinki Written informed consent was obtained from the patients.

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.

Recruitment information / eligibility

• 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.

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Nausea
• Vomiting

Intervention

Other:
• Hypnosis
Hypnosis is added to the conventional group

Locations

Country	Name	City	State
Turkey	Bursa yuksek ihtisas egitim arastirma hastanesi	Bursa	Yildirim/Bursa

Sponsors (1)

Lead Sponsor	Collaborator
Turkiye Yuksek Ihtisas Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

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

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.CD009 — View Citation

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 — View Citation

Philip B. Hyperemesis gravidarum: literature review. WMJ. 2003;102(3):46-51. — View Citation

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

Outcome

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