Use of Hypnosis in Hyperemesis Gravidarum

NCT04828967 | Completed

• 1 other identifier: 66519339-900-01/2015/02-04
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea; Vomiting; Hyperemesis Gravidarum

Keywords

hyperemesis gravidarum; hypnosis; nausea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The effect of hypnosis on hospital stay

  baseline + 12 months

Study Arms (2)

Hypnosis group

EXPERIMENTAL

Hypnosis is added to the conventional group.

Other: Hypnosis

conventional group

NO INTERVENTION

only conventional group

Interventions

Hypnosis OTHER

Hypnosis is added to the conventional group

Also known as: Conventionel

Hypnosis group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Turkiye Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Bursa yuksek ihtisas eğitim araştırma hastanesi

Bursa, Yildirim/Bursa, 16290, Turkey (Türkiye)

Location

Related Publications (8)

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

  PMID: 12822290 RESULT

• Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.

  PMID: 22866186 RESULT

• 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.

  PMID: 21297474 RESULT

• 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.

  PMID: 26156064 RESULT

• 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.

  PMID: 22419342 RESULT

• 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.

  PMID: 23550694 RESULT

• 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.

  PMID: 22805267 RESULT

• 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.

  PMID: 30342643 RESULT

MeSH Terms

Conditions

Nausea; Vomiting; Hyperemesis Gravidarum

Interventions

Hypnosis

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Seyda E Ozgunay

  Bursa Yuksek ihtisas research and training hospital

  PRINCIPAL INVESTIGATOR

• Burcu Cakmak

  Bursa Yuksek ihtisas research and training hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Study Record Dates

• First Submitted: March 27, 2021
• First Posted: April 2, 2021
• Study Start: January 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: November 22, 2023

Record last verified: 2023-11

Locations

TU (1)