Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828967
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2021-03-27
Brief Title:
Use of Hypnosis in Hyperemesis Gravidarum
Sponsor:
Turkiye Yuksek Ihtisas Education and Research Hospital
Organization:
Turkiye Yuksek Ihtisas Education and Research Hospital
Study Overview
Official Title:
The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum A Prospective Randomized Study
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 n18 given hypnosis and GC n23 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
Methods This prospective randomised study was carried out with 41 inpatients diagnosed with HG The patients were grouped as GH n18 given hypnosis and GC n23 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 0no nausea and10extreme 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 09 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 mgday po was routinely used in all patients When the VAS score was 4 the serotonin antagonist ondansetron 4mg iv 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
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 0no nausea and10extreme 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 09 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 mgday po was routinely used in all patients When the VAS score was 4 the serotonin antagonist ondansetron 4mg iv 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None