- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04874298
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The universe of the research; patients who are planned to undergo thyroid surgery between 1 December 2020 and 1 December 2021 in the general surgery clinic where the study will be conducted will comprise the patients who meet the inclusion criteria and agree to participate in the study. The research was planned as a randomized controlled experimental study. Block randomization method will be used to determine the experimental and control groups. In order for the groups to be distributed homogeneously, the order produced by a computer program (https://www.randomizer.org/) will be used. Randomization will be done by a biostatistician outside the researcher. Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental and control groups according to the randomization list. Research data will be collected in a hospital's general surgery ward between 1 December 2020 and 1 December 2021.
Independent variables of the research; age, gender, educational status, marital status, height, weight, habits and general health parameters were defined as independent variables. The dependent variables of the study are postoperative nausea-vomiting status (number and severity), pain severity (Visual Analog Scale-VAS), and Rhodes nausea-vomiting index score average.
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Sona PASHAEI, MSC
- Telefonnummer: +905374869720
- E-mail: sona.pashaei@ogr.iu.edu.tr
Undersøgelse Kontakt Backup
- Navn: Nuray AKYUZ, Dr
- Telefonnummer: +905326256188
- E-mail: nakyuz1@hotmail.com
Studiesteder
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Istanbul, Kalkun
- Rekruttering
- IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul
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Kontakt:
- Sona PASHAEI, MSC
- Telefonnummer: +905374869720
- E-mail: sona.pashaei@ogr.iu.edu.tr
-
Kontakt:
- Nuray AKYUZ, Dr
- Telefonnummer: +905326256188
- E-mail: nakyuz1@hotmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Those who are 18 years old or older,
- According to the American Association of Anesthesiologists (ASA) classification; ASA score I and II,
- Not known ginger and peppermint allergy,
- Patients who are qualified to understand and answer questions in terms of cognitive capacity,
- Patients without any psychiatric disorder,
- Patients who agree to participate in the study will be included in the study.
Exclusion Criteria:
- Under 18 years old,
- Those with nutritional disorders,
- Patients who require additional treatment to prevent nausea and vomiting, or patients using non-prescription anti-nausea and other complementary therapy,
- Patients with peppermint and ginger allergy,
- Those who have additional diseases (gastrointestinal system diseases, central nervous system tumors, vertigo etc.) that may affect the state of nausea and vomiting,
- Not agreeing to participate in the research,
- Those with respiratory diseases such as asthma, COPD, etc.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Ingen indgriben: Kontrolarm
I kontrolgruppen vil der ikke blive ansøgt under og efter det kirurgiske indgreb, og der vil blive anvendt rutinemæssig behandling og pleje.
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Eksperimentel: Intervention Arm 1 (Ginger Group)
Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use ginger oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Ginger and Peppermint oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Eksperimentel: Intervention Arm 2 (Peppermint Group)
Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group.
In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Peppermint oil as inhalation.
The structure of the inhaler tube is explained.
The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it.
Cotton swab 1 ml of essential oil is added by dropping on it.
The back cover of the inhaler tube is closed.
It is waited for 10-15 minutes.
The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube.
With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube.
The essential oil tubes to be applied will be prepared separately for each patient and that day.
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Peppermint
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Postoperativ smerte sværhedsgrad
Tidsramme: Rapporterede smertesværhedsgrad i de første 24 timer efter operationen
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Smertesværhedsvurdering med Visual Assessment Scale (VAS) Score: 0-10; 0- Ingen smerte, 10- Værste smerte
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Rapporterede smertesværhedsgrad i de første 24 timer efter operationen
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Postoperativ kvalme og opkastning sværhedsgrad
Tidsramme: Rapporteret sværhedsgrad af kvalme og opkastning i de første 24 timer efter operationen
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Sværhedsgrad af kvalme og opkastning med Visual Assessment Scale (VAS) Score: 0-10; 0- Ingen, 10- Pinligt
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Rapporteret sværhedsgrad af kvalme og opkastning i de første 24 timer efter operationen
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Brug af antiemetika
Tidsramme: I de første 24 timer efter operationen
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Navn, dosis, hyppighed og tidspunkt for de antiemetika
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I de første 24 timer efter operationen
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The number of postoperative nausea, vomiting and retching
Tidsramme: Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
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The number of nausea, vomiting
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Reported the number of nausea, vomiting and retching in the first 24 hours after surgery
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Rhodes Nausea Vomiting Index score
Tidsramme: At the end of the 24th hour after surgery
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Evaluation of Rhodes Nausea Vomiting Index score In order to score the scale, responses to items 1, 3, 6 and 7 are calculated in reverse order; For each answer, they are scored as 0: minimum, 4: most discomfort, and the score obtained from 8 items is added.
It is expressed as 32 points, the highest possible value.
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At the end of the 24th hour after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Postoperative complications
Tidsramme: End of surgery to hospital discharge 2-3 days
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Evaluation of postoperative complications
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End of surgery to hospital discharge 2-3 days
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Yeliz E Ersoy, Prof.Dr, Bezmialem University
- Studieleder: Nuray AKYUZ, Dr, Istanbul University - Cerrahpasa (IUC)
- Studiestol: Sona PASHAEI, MSC, Istanbul University - Cerrahpasa (IUC)
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2020-8-1
Plan for individuelle deltagerdata (IPD)
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