- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT04874298
The Effect of Ginger and Peppermint on Postoperative Nausea and Vomiting in Patients After Thyroid Surgery
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sona PASHAEI, MSC
- Numéro de téléphone: +905374869720
- E-mail: sona.pashaei@ogr.iu.edu.tr
Sauvegarde des contacts de l'étude
- Nom: Nuray AKYUZ, Dr
- Numéro de téléphone: +905326256188
- E-mail: nakyuz1@hotmail.com
Lieux d'étude
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Istanbul, Turquie
- Recrutement
- IU-Cerrahpaşa Florence Nightingale Faculty of Nursing Department of Surgical Nursing Abide-i Hürriyet street. 34381 Sisli - Istanbul
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Contact:
- Sona PASHAEI, MSC
- Numéro de téléphone: +905374869720
- E-mail: sona.pashaei@ogr.iu.edu.tr
-
Contact:
- Nuray AKYUZ, Dr
- Numéro de téléphone: +905326256188
- E-mail: nakyuz1@hotmail.com
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Bras de commande
Dans le groupe témoin, aucune application ne sera faite pendant et après l'intervention chirurgicale, et un traitement et des soins de routine seront appliqués.
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Expérimental: 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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Expérimental: 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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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Intensité de la douleur postopératoire
Délai: Sévérité de la douleur rapportée dans les 24 premières heures après la chirurgie
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Évaluation de la sévérité de la douleur avec le score de l'échelle d'évaluation visuelle (EVA) : 0-10 ; 0- Pas de douleur, 10- Pire douleur
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Sévérité de la douleur rapportée dans les 24 premières heures après la chirurgie
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Sévérité des nausées et vomissements postopératoires
Délai: Gravité des nausées et des vomissements signalés dans les 24 premières heures après la chirurgie
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Sévérité des nausées et des vomissements avec le score de l'échelle d'évaluation visuelle (EVA) : 0-10 ; 0- Aucun, 10- Atroce
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Gravité des nausées et des vomissements signalés dans les 24 premières heures après la chirurgie
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Utilisation d'antiémétiques
Délai: Dans les 24 premières heures après la chirurgie
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Le nom, la dose, la fréquence et l'heure des médicaments antiémétiques
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Dans les 24 premières heures après la chirurgie
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The number of postoperative nausea, vomiting and retching
Délai: 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
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
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Postoperative complications
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Yeliz E Ersoy, Prof.Dr, Bezmialem University
- Directeur d'études: Nuray AKYUZ, Dr, Istanbul University - Cerrahpasa (IUC)
- Chaise d'étude: Sona PASHAEI, MSC, Istanbul University - Cerrahpasa (IUC)
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2020-8-1
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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