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临床试验/NCT06661239
NCT06661239已完成不适用

Effect of Benson Relaxation Technique on Pain Level, Insomnia, Nausea, Vomiting, and Retching in Oncology Patients Admitted to Intensive Care Units

Damanhour University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Respiratory rate

研究概览

简要总结

The benson Relaxation Technique (BRT), developed by Dr. Herbert Benson, is a method aimed at reducing stress and anxiety through a series of simple steps designed to elicit the "Relaxation Response." This response is a physiological state that counteracts the harmful effects of stress, characterized by decreased heart rate, lower metabolism, and reduced breathing rate

详细描述

The benson relaxation consisted of the following steps: (1) Sitting or lying down quietly in a comfortable position; (2) Closing eyes; (3) Deeply relaxing all muscles, beginning at the feet and progressing up to the face. Keeping them relaxed; (4) Breathing through the nose. Becoming aware of breathing. Focus on a word, phrase, a short prayer, or only breathing. (6) Continuing for 15 minutes. When finished, sit quietly for several minutes, at first with eyes closed and later with eyes opened. Do not stand up for a few minutes.

According to the agreement, the patients in both groups were required to perform the Benson relaxation technique regularly twice daily (morning and evening) for three days in a row. Each session lasted 15 minutes

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None (Participant)

盲法说明

The studied patients will be masked for the intervention

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients aged 18-60 years
  • diagnosed with cancer
  • alert and able to communicate.

排除标准

  • Patients who refused to participate in the study
  • Patients with cognitive impairment
  • Patient who unable to communicate

研究组 & 干预措施

The benson group

Experimental

Patients who received the intervention

干预措施: benson relaxation (Behavioral)

Control group

Placebo Comparator

Patients who receive routine care in units

干预措施: Routine care in unit (Behavioral)

结局指标

主要结局

Respiratory rate

时间窗: daily for three days

measure respiratory rate per min

Heart rate

时间窗: daily for three days

measure heart rate per min

Blood pressure

时间窗: daily for three days

measure blood pressure in mmHg

The Rhodes Index of Nausea, Vomiting, and Retching

时间窗: daily for three days

It is a self-report tool designed to assess the severity and impact of nausea, vomiting, and retching on patients' 5-point categorical scales, the interval of each category was (maximum possible score/4-1 ) with the score being zero in the "none" category. For example, if the maximum possible score was 32, then, none: 0, mild: 1-8, moderate: 9-16, severe: 17-24, great: 24-32.

Insomnia Severity Index Scale

时间窗: daily for three days

The Insomnia Severity Index (ISI) is a widely used self-report questionnaire designed to assess the severity of insomnia. It consists of seven questions, each rated on a scale that reflects the severity of sleep problems experienced over the last two weeks. The total score is calculated by summing the responses to all seven items, with potential scores ranging from 0 to 28. Total Score Calculation 0-7: No clinically significant insomnia 8-14: Subthreshold insomnia 15-21: Clinical insomnia (moderate severity) 22-28: Clinical insomnia (severe)

The Numeric Pain Rating Scale

时间窗: daily for three days

The patient is asked to make three pain ratings, corresponding to current, best and worst pain experienced over the past 24 hours. scale is the most widely used single-dimension assessment scale.The total score is divided into 4 main categories: zero, which indicates no pain; 1-3 grades, which indicates mild pain; 4-6 grades, which indicate moderate pain; and 7-10 grades, which indicate severe pain

次要结局

  • Icu length(an average three months)
  • ICU length(an average three months)

研究者

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

Shimmaa Elsayed

ِAssist professor

Damanhour University

研究点 (1)

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