Use of Hypnosis in Hyperemesis Gravidarum
Primary Purpose
Nausea, Vomiting, Hyperemesis Gravidarum
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Hypnosis
Sponsored by
About this trial
This is an interventional treatment trial for Nausea focused on measuring hyperemesis gravidarum, hypnosis, nausea
Eligibility Criteria
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.
Sites / Locations
- Bursa yuksek ihtisas eğitim araştırma hastanesi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Hypnosis group
conventional group
Arm Description
Hypnosis is added to the conventional group.
only conventional group
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT04828967
First Posted
March 27, 2021
Last Updated
March 30, 2021
Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04828967
Brief Title
Use of Hypnosis in Hyperemesis Gravidarum
Official Title
The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum: A Prospective Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
January 1, 2018 (Actual)
Study Completion Date
January 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Turkiye Yuksek Ihtisas Education and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Hyperemesis Gravidarum
Keywords
hyperemesis gravidarum, hypnosis, nausea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hypnosis group
Arm Type
Experimental
Arm Description
Hypnosis is added to the conventional group.
Arm Title
conventional group
Arm Type
No Intervention
Arm Description
only conventional group
Intervention Type
Other
Intervention Name(s)
Hypnosis
Other Intervention Name(s)
Conventionel
Intervention Description
Hypnosis is added to the conventional group
Primary Outcome Measure Information:
Title
The Effect of Adjuvant Hypnosis on Nausea and Vomiting in Hyperemesis Gravidarum
Description
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).
Time Frame
baseline + 12 months
Secondary Outcome Measure Information:
Title
The effect of hypnosis on hospital stay
Description
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).
Time Frame
baseline + 12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seyda E Ozgunay
Organizational Affiliation
Bursa Yuksek ihtisas research and training hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Burcu Cakmak
Organizational Affiliation
Bursa Yuksek ihtisas research and training hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bursa yuksek ihtisas eğitim araştırma hastanesi
City
Bursa
State/Province
Yildirim/Bursa
ZIP/Postal Code
16290
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
12822290
Citation
Philip B. Hyperemesis gravidarum: literature review. WMJ. 2003;102(3):46-51.
Results Reference
result
PubMed Identifier
22866186
Citation
Wegrzyniak LJ, Repke JT, Ural SH. Treatment of hyperemesis gravidarum. Rev Obstet Gynecol. 2012;5(2):78-84.
Results Reference
result
PubMed Identifier
21297474
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.
Results Reference
result
PubMed Identifier
26156064
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.
Results Reference
result
PubMed Identifier
22419342
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.CD009234.pub2.
Results Reference
result
PubMed Identifier
23550694
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.
Results Reference
result
PubMed Identifier
22805267
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 chemotherapy. Int J Clin Pract. 2012 Aug;66(8):753-757. doi: 10.1111/j.1742-1241.2012.02969.x. Epub 2012 Jul 2.
Results Reference
result
PubMed Identifier
30342643
Citation
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.
Results Reference
result
Learn more about this trial
Use of Hypnosis in Hyperemesis Gravidarum
We'll reach out to this number within 24 hrs