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Набор скоро начнётся NCT07520773

Therapeutic Touch on Sleep, Comfort, and Physiological Parameters in Intensive Care Patients

Без фазы С лечением Intensive Care Patients

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: Therapeutic Touch.
Кому может быть актуально
Состояния в реестре: Intensive Care Patients. Базовые параметры: 18 лет — 80 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 Therapeutic Touch on Sleep, Comfort, and Physiological Parameters in Intensive Care Patients: A Randomized, Placebo-Controlled Study

Обзор

Intensive care units are critical clinical areas where patients in life-threatening conditions receive care under advanced technology and continuous monitoring. In this environment, patients' sleep patterns and comfort levels are frequently disrupted, which can negatively affect physiological stability and the recovery process. The aim of this thesis proposal is to examine the effects of therapeutic touch applied to intensive care patients on sleep quality, comfort level, and physiological parameters. The research is planned as a randomized experimental study with intervention, placebo, and control groups. The study will be conducted in the Coronary Intensive Care Unit of Fırat University Hospital between April 2026 and January 2027, and a total of 90 patients meeting the research criteria will be randomized into intervention (n=30), placebo (n=30), and control (n=30) groups. The research materials consist of the Patient Identification Form, VAS-Comfort Scale, Sleep Scale, and measurements of physiological parameters (heart rate, blood pressure, body temperature, respiratory rate, oxygen saturation). The intervention group will receive therapeutic touch, the placebo group will receive superficial contact, and the control group will receive routine care. The applications will be performed daily at 8:00 PM, and comfort scale and physiological parameters will be measured before and 30 minutes after the application. Sleep quality, as an outcome variable occurring throughout the night, will be assessed the following day using the Sleep Scale. This process will be repeated for 3 days. The obtained data will be analyzed using appropriate statistical methods. In addition to descriptive statistics, One-Way Analysis of Variance (ANOVA) will be used for intergroup comparisons, and Repeated Measures ANOVA will be used to evaluate changes over time. In case of a significant difference, Bonferroni corrected post-hoc tests will be applied. If parametric assumptions are not met, appropriate non-parametric tests will be preferred. The significance level will be accepted as p\<0.05. This study aims to contribute to the development of evidence-based practices in nursing care by revealing the effects of therapeutic touch on sleep quality, comfort level, and physiological parameters of intensive care patients.

Вмешательства

  • Поведенческое Therapeutic Touch
    Therapeutic Touch

Первичные конечные точки

  • Visual Analog Scale-Comfort [Срок оценки: 30 minutes post-intervention)]
  • Richard Campbell Sleep Questionnaire [Срок оценки: One day after the procedure]
  • The Therapeutic Touch Pre/Post Physiological Parameters Form [Срок оценки: 30 minutes post-intervention]

Критерии участия

Критерии включения

  • Adults aged 18 and over.
  • Patients who can communicate verbally.
  • Patients monitored in the intensive care unit for at least 3 days.
  • Patients who can give informed consent.
  • Hemodynamically stable patients.

Критерии исключения

  • Patients under deep sedation.
  • Patients on mechanical ventilation.
  • Patients with psychiatric problems.
  • Patients with skin diseases or conditions such as open wounds, infections, or burns that would prevent therapeutic touch.
  • Patients with excessive sedation or delirium due to sedative/analgesic use.
  • Patients experiencing sudden, life-threatening clinical changes during intensive care (e.g., sudden cardiac arrest or shock).

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

Здоровые добровольцы: Да

Дизайн исследования

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

Центры проведения

Turkey (Türkiye) · 1 центр
  • Fırat university — Elâzığ

Идентификаторы

NCT: NCT07520773 · 2026/02-03

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗