Меню
Идёт набор NCT07306689

Posttraumatic Stress Disorder in Ectopic Pregnancy

Наблюдательное Ectopic Pregnancy

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: Impact of Event Scale - Revised (IES-R) questionnaire, Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire, Trauma Recovery Measure (TRM) questionnaire.
Кому может быть актуально
Состояния в реестре: Ectopic Pregnancy. Базовые параметры: 18 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Польша
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Posttraumatic Stress Disorder Symptoms Complicating Ectopic Pregnancy

Обзор

The objective of the study is to prospectively assess the prevalence of post-traumatic stress disorder (PTSD) symptoms in a population of women who have experienced a diagnosis of ectopic pregnancy. The investigation into the prevalence of PTSD symptoms will aid in better identifying women who may benefit from early psychological intervention.

Подробное описание

A questionnaire-based study will be conducted with prospective inclusion of participants, based on the analysis of medical documentation and self-administered questionnaires. The following questionnaires are proposed for use:

i. Impact of Event Scale - Revised (IES-R) is a 22-item test that measures the level of stress and anxiety resulting from traumatic events. It is utilized as a screening tool in diagnosing post-traumatic stress disorder (PTSD). The test consists of 22 questions that relate to the respondent's feelings, behaviors, and thoughts concerning the traumatic event over the past seven days. For each question, respondents will indicate one of five responses that best reflects their experience:

0 - Not at all

1. \- A little 2. \- Moderately 3. \- Often 4. \- Very often

Upon completion of all questions and totaling the points, the scale for symptoms is classified as follows:

0-23 points: No or mild symptoms 24-32 points: A significant number of symptoms 33 points or more: Most symptoms characteristic of PTSD. The questionnaire will be completed during hospitalization.

ii. Posttraumatic Stress Disorder Checklist - Specific (PCL-S) is a 17-item test designed to detect symptoms of PTSD resulting from a specific traumatic event. This test includes 17 questions related to the behaviors and feelings of the respondent over the past month. Each question is answered using a 5-point scale with assigned points: Not at all - 1 point Sometimes - 2 points Moderately often - 3 points Often - 4 points Very often - 5 points

After totaling the points, they are classified as follows:

17-29 points: No or few PTSD symptoms 30-44 points: Moderate to moderately high PTSD symptoms 45-85 points: Numerous PTSD symptoms. The questionnaire will be completed during a routine follow-up visit at the outpatient clinic eight weeks post-discharge from the hospital.

iii. Trauma Recovery Measure (TRM) is a 15-item tool designed to assess trauma and the recovery process. It enables a structured evaluation of the multifaceted impact of trauma on an individual, facilitating the adjustment of support and intervention strategies.

The TRM provides a total score as well as three subscale scores that assess the cognitive aspects of the individual following the experience of traumatic events. The three subscales within the TRM include:

* Validation: This subscale measures the acceptance and self-acceptance of the trauma survivor as they are, despite the traumatic experience, and evaluates the development of internal worth and dignity. * Liberation: This subscale assesses the survivor's ability to free themselves from control, entrapment, and/or oppression caused by the trauma, and their capacity to live in a way that allows them to feel empowered and confident in making positive decisions for themselves and others. * Positive Self: This subscale measures the presence of positive cognitive aspects that generate feelings of care, compassion, and/or kindness.

The stage of recovery is presented based on the distance of the score from the mean. There are three possible stages of recovery:

* Early Stage of Recovery: Less than 1 standard deviation below the mean (total score of 31 or fewer). * Middle Stage of Recovery: Total score ranging from 32 to 61. * Late Stage of Recovery: More than 1 standard deviation above the mean (total score of 62 or more).

The questionnaire will be completed during a routine follow-up visit at the outpatient clinic eight weeks post-discharge from the hospital.

Вмешательства

  • Диагностический тест Impact of Event Scale - Revised (IES-R) questionnaire
    The test consists of 22 questions that relate to the respondent's feelings, behaviors, and thoughts concerning the traumatic event over the past seven days. For each question, respondents will indicate one of five responses that best reflects their experience: 0 - Not at all 1. \- A little 2. \- Moderately 3. \- Often 4. \- Very often Upon completion of all questions and totaling the points, the scale for symptoms is classified as follows: 0-23 points: No or mild symptoms 24-32 points: A sig
  • Диагностический тест Posttraumatic Stress Disorder Checklist - Specific (PCL-S) questionnaire
    This test includes 17 questions related to the behaviors and feelings of the respondent over the past month. Each question is answered using a 5-point scale with assigned points: Not at all - 1 point Sometimes - 2 points Moderately often - 3 points Often - 4 points Very often - 5 points After totaling the points, they are classified as follows: 17-29 points: No or few PTSD symptoms 30-44 points: Moderate to moderately high PTSD symptoms 45-85 points: Numerous PTSD symptoms.
  • Диагностический тест Trauma Recovery Measure (TRM) questionnaire
    15-item tool designed to assess trauma and the recovery process. The stage of recovery is presented based on the distance of the score from the mean. There are three possible stages of recovery: * Early Stage of Recovery: Less than 1 standard deviation below the mean (total score of 31 or fewer). * Middle Stage of Recovery: Total score ranging from 32 to 61. * Late Stage of Recovery: More than 1 standard deviation above the mean (total score of 62 or more).

Первичные конечные точки

  • Impact of Event Scale - Revised (IES-R) score [Срок оценки: up to 3 months]
  • Posttraumatic Stress Disorder Checklist - Specific (PCL-S) score [Срок оценки: up to 3 months]
  • Trauma Recovery Measure (TRM) score [Срок оценки: up to 3 months]

Критерии участия

Критерии включения

  • ectopic pregnancy
  • gestational age up to 14 weeks.

Критерии исключения

  • heterotopic pregnancy

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Польша · 2 центра
  • Jagiellonian University Medical College, Department of Gynecology and Obstetrics — Krakow
  • Jagiellonian University Medical College — Krakow

Идентификаторы

NCT: NCT07306689 · 118.0043.1.344.2025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗