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临床试验/NCT05959785
NCT05959785已完成不适用

Diaphragmatic Exercises As Treatment of Referred Pain After Total Laparoscopic Hysterectomy: Randomized Controlled Clinical Trial.

University of Seville4 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2023年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
74
试验地点
4
主要终点
The Quick Dash quiz

研究概览

简要总结

Through a blinded clinical trial, the aim is to evaluate the efficacy of manual therapy in the treatment of pain referred to after laparoscopic hysterectomy.

Control and intervention groups were randomly established. Informed consent will be requested for participation in the study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

盲法说明

plain blind

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • • Patients who have given their consent to participate in the project by signing the informed consent.
  • Patient between 18 and 65 years of age.
  • Patients with a hysterectomy scheduled to be performed in less than 3 months at the Women's Hospital in Seville or at the Quirón Sagrado Corazón Clinic in Seville.
  • Who develops pain of intensity greater than 7 points located in the head, neck or upper limbs in the first 24 hours post-hysterectomy.
  • Patients who are able to communicate in Spanish or English.

排除标准

  • Neurological Pathology.
  • Non-cooperative Subject.
  • Severe Psychiatric Illness.
  • Loss of Cognitive Capacity.
  • Evidence that post-hysterectomy pain is not caused by surgery (eg, presence of fracture or infection in the head, neck or upper limbs.
  • Localized pain in areas not considered in this study and that may affect the performance and results of the study.

结局指标

主要结局

The Quick Dash quiz

时间窗: 24 hours after laparoscopy

Questionnaire containing questions about symptoms and the ability to use instruments of the upper limbs. Collect data referring to the last week

The McGill Pain Questionnaire

时间窗: 24 hours after laparoscopy

Location of pain: which is usually represented by a schematic figure of the human body, where the patient points out the areas where they feel pain. * Quality of pain: the patient must choose from a wide list of types of pain those characteristics that define the one he presents. They are grouped into various categories that in turn form four large groups: sensory, emotional, evaluative and miscellaneous. In the original English version, the number of words was 78, although they may vary in the different validations of the questionnaire (66 in the Spanish version). * Pain intensity at the current moment: explored by means of a question with five possible response categories. * Assessment of pain at the current time using a visual analogue scale, ranging from "no pain" to "unbearable pain".

The Brief Pain Questionnaire

时间窗: 24 hours after laparoscopy

This questionnaire, in its short version, includes a body map that the patient can use to mark the areas where pain is located. In addition to providing a useful tool for localizing pain, this questionnaire provides important information about other characteristics of pain, as well as response to prescribed treatments.

The Neck Disability Index questionnaire

时间窗: 24 hours after laparoscopy

assesses neck and back pain and its influence on basic activities of daily living

The HIT-6 scale

时间窗: 24 hours after laparoscopy

evaluates the headache through 6 questions

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Antonio Luis Partida Márquez

Diplomado en Enfermería

University of Seville

研究点 (4)

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