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Набор скоро начнётся NCT07273162

The Effect of Cold Vapor on Dyspnea, Thirst, Nausea, and Physiological Parameters in the PACU After Laparoscopic Inguinal Hernia Surgery

Без фазы С лечением Patients Undergoing Laparoscopic Inguinal Hernia Repair

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Cold Vapor.
Кому может быть актуально
Состояния в реестре: Patients Undergoing Laparoscopic Inguinal Hernia Repair. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Turkey (Türkiye)
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

The Effect of Cold Vapor Inhalation on Dyspnea Thirst Nausea and Physiological Parameters in the Recovery Unit After Laparoscopic Inguinal Hernia Surgery

Обзор

Cold vapor application is considered a promising intervention with the potential to alleviate side effects associated with anesthesia and surgery in the postoperative period. This study aims to determine the effect of cold vapor inhalation on dyspnea, thirst, nausea, and physiological parameters following laparoscopic inguinal hernia surgery. Hypotheses (H1); H1a: Patients administered cold vapor will report lower dyspnea severity compared to the control group. H1b: Patients administered cold vapor will report lower thirst levels compared to the control group. H1c: Patients administered cold vapor will report lower nausea severity compared to the control group. H1d: Patients administered cold vapor will show significant differences in physiological parameters compared to the control group.

Подробное описание

Non-pharmacological methods, such as cold vapor application, hold significant potential in the management of complications encountered in the postoperative period. Despite this potential, to the best of our knowledge, no published study examining the effect of cold vapor on dyspnea, thirst, and physiological parameters has been found in the literature. This study is a randomized controlled experimental study. The study will be conducted with at least 66 patients in total, including 33 in the intervention group and 33 in the control group. Data collection consists of three stages: T0, T1, and T2. In these stages, the baseline (T0) assessment of both groups will be performed using the Questionnaire Form, Modified Borg Scale (MBS), Perioperative Thirst Discomfort Scale (PTDS), Numerical Rating Scale (NRS), and Physiological Parameter Follow-up Form (PPFF). Following this assessment, the patients' condition will be re-evaluated at the 15th minute (T1) and 30th minute (T2) using the MBS, PTDS, NRS, and PPFF. In the intervention group, immediately after the baseline (T0) assessment, cold steam application will be administered to patients for 15 minutes using a Hikoneb 906 S/LCD ultrasonic hospital-type nebulizer device, in addition to routine care and treatment procedures. Patients in the control group will not be subjected to any additional intervention. It is predicted that cold vapor inhalation will reduce the severity of dyspnea, thirst, and nausea after laparoscopic inguinal hernia surgery as a result of the study. Additionally, it is expected to bring basic vital parameter values such as systolic and diastolic blood pressure, heart rate (pulse/min), peripheral oxygen saturation (SpO2, %), and respiratory rate (/min) closer to the normal physiological range. This study is significant as it demonstrates the value of cold vapor as a practice that strengthens and supports individualized nursing care in the early postoperative period.

Вмешательства

  • Другое Cold Vapor
    Cold steam application will be performed using a Hikoneb 906 S/LCD ultrasonic nebulizer, which will generate cold steam with distilled water. Device parameters will be optimally set to steam delivery level 5 (1-10), steam density level 5 (1-10), and steam temperature 1C0 (1C0-10C0). This application will be applied to the intervention group for 15 minutes after the baseline (T0) assessment. Cold steam will not be delivered directly to the airways but will be applied to the facial area, covering

Первичные конечные точки

  • Survey Form [Срок оценки: Baseline (T0)]
  • Modified Borg Scale (MBS) for Dyspnea [Срок оценки: Baseline (T0), 15th minute (T1) and 30th minute (T2)]
  • Numerical Rating Scale (NRS) for Nausea Level [Срок оценки: Baseline (T0), 15th minute (T1) and 30th minute (T2)]
  • Surgical Period Thirst-Related Discomfort Scale (SPTRDS) [Срок оценки: Baseline (T0), 15th minute (T1) and 30th minute (T2)]
  • Physiological Parameter Monitoring Form (PPMF) [Срок оценки: Baseline (T0), 15th minute (T1) and 30th minute (T2)]

Критерии участия

Критерии включения

  • Volunteering to participate in the study
  • Being aged 18 years or older
  • Being able to speak and understand Turkish
  • Having cognitive, affective, and communicative competence
  • Having intact visual and auditory functions
  • Having undergone elective laparoscopic inguinal hernia surgery under general anesthesia
  • Having an ASA score of I or II
  • Having a total Modified Aldrete Score of ≥9 and a consciousness score of 2 (fully awake) in the postoperative period
  • Not having developed vomiting prior to the intervention
  • Having a body temperature within the normal physiological range (36-37.5 °C)

Критерии исключения

  • Having cold vapor application planned by physician order in the PACU prior to the study
  • Having signs and symptoms of upper or lower airway obstruction
  • Developing agitation and having communication insufficiency
  • Having an allergy to cold vapor application
  • Having a diagnosis of obstructive pulmonary disease (e.g., COPD, asthma) or heart failure
  • Having a known history of any neurological or psychiatric disease
  • Having a postoperative nasogastric catheter inserted
  • Having received preoperative diagnoses associated with nausea, vomiting, or dyspnea

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр
  • Erciyes University — Kayseri

Идентификаторы

NCT: NCT07273162 · 2025-10/14

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗