Use of Hypnosis in Hyperemesis Gravidarum

Sponsor

Turkiye Yuksek Ihtisas Education and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04828967

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Nausea Vomiting Hyperemesis Gravidarum	Other: Hypnosis	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

41 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Adjuvant Hypnosis Added to Conventional Therapy on Nausea and Vomiting in Hyperemesis Gravidarum: A Prospective Randomized Study

Actual Study Start Date :

Jan 1, 2017

Actual Primary Completion Date :

Jan 1, 2018

Actual Study Completion Date :

Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hypnosis group Hypnosis is added to the conventional group.	Other: Hypnosis Hypnosis is added to the conventional group Other Names: Conventionel
No Intervention: conventional group only conventional group

Arm

Intervention/Treatment

Experimental: Hypnosis group

Hypnosis is added to the conventional group.

Other: Hypnosis

Hypnosis is added to the conventional group

Other Names:

Conventionel

No Intervention: conventional group

only conventional group

Outcome Measures

Primary Outcome Measures

The Effect of Adjuvant Hypnosis on Nausea and Vomiting in Hyperemesis Gravidarum [baseline + 12 months]
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 [baseline + 12 months]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bursa yuksek ihtisas eğitim araştırma hastanesi	Bursa	Yildirim/Bursa	Turkey	16290

Sponsors and Collaborators

Turkiye Yuksek Ihtisas Education and Research Hospital

Investigators

Principal Investigator: Seyda E Ozgunay, Bursa Yuksek ihtisas research and training hospital
Principal Investigator: Burcu Cakmak, Bursa Yuksek ihtisas research and training hospital