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临床试验/NCT06994715
NCT06994715招募中不适用

Effects of Acupressure Applied to Intensive Care Patients on Physiological Parameters, Pain, Sleep Quality, Anxiety and Perception of Nursing Presence

Gazi University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
1
主要终点
Visual Assessment Scale

研究概览

简要总结

This study will be conducted in a randomized controlled experimental design to examine the effects of acupressure applied to patients treated in the intensive care unit on physiological parameters, pain, sleep quality, anxiety and perception of nurse presence. The study will be conducted with 60 patients (20 intervention, 20 placebo, 20 control groups) treated in the 2nd stage Intensive Care Unit of an University Hospital between May 2025 and January 2026. Acupressure will be applied to the intervention group for 2 days, morning and evening, for four sessions. For four sessions, pseudo acupressure will be used on the placebo group for 2 days, morning and evening. No application will be made to the control group. The data collection tools in the study are the Patient Identifier Information Form, Glasgow Coma Scale (GCS), Visual Assessment Scale (VAS), Physiological Parameter Assessment Form, Richards-Campbell Sleep Scale, Spielberg State-Trait Anxiety Inventory, and Nurse Presence Scale (PONS).

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Have received intensive care treatment for at least 48 hours,
  • •Are 18 years of age or older,
  • •Have a Glasgow Coma Scale score of >13,
  • •Can speak and write in Turkish,
  • •Have no psychiatric diagnosis,
  • •Have no communication problems,
  • •Have a VAS score of ≥1,
  • •Have a mean arterial pressure of ≥65,
  • •Have SpO2 of ≥85.

排除标准

  • •Have previously received acupressure treatment,
  • •Have ulcers, necrotic tissue and signs and symptoms of infection at the points where pressure will be applied,
  • •Have used antihypertensives, beta-blockers and similar medications,
  • •Have sedation,
  • •Have respiratory support from the device,
  • •Have inotropic treatment (dopamine, steradin and others),
  • •Have analgesic treatment in their routine treatment will not be included in the study.
  • •Patients who were discharged during the study,
  • •Patients who died during the study,
  • •Patients who wanted to leave the study,
  • •Patients who started receiving sedation during the application,
  • •Patients who added antihypertensive, beta-blocker and similar drugs to their routine treatment during the application,
  • •Patients who received inotropic treatment (dopamine, steradin and others) during the application,
  • •Patients who started receiving analgesia treatment during the application,
  • •Patients who developed ulcers, necrotic tissue and infection at the points where pressure will be applied during the application,
  • •Patients who started receiving respiratory support from the device during the application,
  • •Patients who had a Glasgow Coma Scale score of ≤13, mean arterial pressure of ≤65 and SpO2 of ≤85 during the application will be excluded from the study.

研究组 & 干预措施

Application group

Experimental

After the purpose of the study and the method of application are explained to the intensive care patients, the "Introductory Information Form", "Glasgow Coma Scale", "Visual Assessment Scale", "Physiological Parameters Assessment Form", "Richards-Campbell Sleep Scale", "Nursing Presence Scale" and "Spielberg State-Trait Anxiety Scale" will be applied. A total of 8 sessions of acupressure will be applied morning and evening for 2 days. The measurements will be repeated afterwards.

干预措施: Acupressure (Other)

Placebo Group

Placebo Comparator

After the purpose of the study and the method of application are explained to the intensive care patients, the "Introductory Information Form", "Glasgow Coma Scale", "Visual Assessment Scale", "Physiological Parameters Assessment Form", "Richards-Campbell Sleep Scale", "Nursing Presence Scale" and "Spielberg State-Trait Anxiety Scale" will be applied. A total of 8 sessions of pseudo acupressure will be applied morning and evening for 2 days. Only light pressure will be applied without massage 2 cm to the side of the real points. The procedure will be performed with gloves. The measurements will be repeated afterwards.

干预措施: pseudo acupressure (Other)

Control Group

No Intervention

No application will be made to the control group.

结局指标

主要结局

Visual Assessment Scale

时间窗: 1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application

VAS is a measurement tool frequently used in the clinic for pain assessment. The ruler, which is indicated as 0-10 cm or 0-100 mm, has no pain (0) written on one end and the most severe pain (10) on the other end. It is scored between 0-10. The patient marks the point on the ruler where he feels the pain.

Spielberg State-Trait Anxiety Scale

时间窗: 1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application and third day morning.

The scale consists of two sub-dimensions measuring continuous and state anxiety. There are 20 questions for each sub-dimension on a 4-point Likert scale (not at all = 1, a little = 2, a lot = 3, completely = 4). The minimum-maximum score range that can be obtained from the scale varies between 20-80. Increasing scores on the scale indicate an increase in the level of anxiety.

Physiological Parameters Assessment Form

时间窗: 1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application

Systolic Blood Pressure (mm/Hg), Diastolic Blood Pressure (mm/Hg), Respiratory Rate, Heart Rate (Pulse) (beats/min) and Saturation parameters measured before and after acupressure of the intervention and placebo groups will be recorded. Systolic blood pressure measurements will be averaged. Diastolic blood pressure measurements will be averaged. Saturation measurements will be averaged. Respiratory rate measurements will be averaged. Heart Rate (Pulse) measurements will be averaged.

Nursing Presence Scale

时间窗: 1st day 15 minutes before application and third day morning.

The scale designed as a 5-point Likert is scored as follows; (never: 1 point), (rarely: 2 points), (occasionally/sometimes: 3 points), (frequently: 4 points) and (always: 5 points). The minimum and maximum scores that can be obtained from the scale are calculated between 24-120. An increase in the score obtained from the scale means that the behaviors in which the patient presents the presence of the nurse have increased and that the patient perceives these behaviors positively.

次要结局

  • Richards-Campbell Sleep Scale(1st day and second day- morning and evening; 15 minutes before application and 30 minutes after the application and third day morning.)

研究者

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

Özlem Canbolat

Gazi University

Gazi University

研究点 (1)

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