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临床试验/NCT06919978
NCT06919978已完成不适用

Effect of Position to Prevent Pleural Irritation (PPPI) on Pain Level and Sleep Quality in Patients With Chest Tube: A Single-blind Quasi-experimental Study.

Akdeniz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年6月20日最近更新:
适应症
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
Pain Level

研究概览

简要总结

Clinical Trial Aim: The study was conducted to investigate the effect of the Position given to Prevent Pleural Irritation (PPPI) due to chest tube on pain level and sleep quality in patients undergoing thoracic surgery.

Does the Position to Prevent Pleural Irritation (PPPI) reduce participants' pain levels due to pleural irritation? Does the Position to Prevent Pleural Irritation (PPPI) improve participants' sleep quality? Researchers were compare the effectiveness of the Position to Prevent Pleural Irritation (PPPI) in reducing pain from pleural irritation and improving sleep quality with routine clinical care.

Participants received the in-bed position and the Position to Prevent Pleural Irritation (PPPI) applied by the researcher in routine care before their first night's sleep in the clinic after thoracotomy. At the same time, participants' pain was be assessed with a pain scale, and their sleep quality was be assessed with a PolySomnioGraph (PSG) and sleep scale.

详细描述

The participants in the study group were positioned in bed the Position to Prevent Pleural Irritation (PPPI) in order to minimize pleural irritation caused by the contact of the chest tube with the pleura during sleep. Routine care was applied by the researcher in the clinic's prosedure for the participants in the control group.

Position to Prevent Pleural Irritation (PPPI)

  1. The participants were informed before the surgery and consent was obtained. The positioning and sleep measurement method were explained. Sleeping scale was filled out for information about the sleep routine before hospitalization.
  2. When the participants were admitted to the thoracic surgery clinic, information about positioning and sleep measurement was given by the researcher.
  3. The researcher questioned and evaluated the patient's pain before bedtime, and routine analgesic were applied.
  4. It was checked that the participant's bed was in working order for the Position to Prevent Pleural Irritation (PPPI), and the positions that could be given with the bed's remote control were explained to the participant.
  5. The position and working order of the chest drainage system and drainage tube were checked.
  6. The participant was given an upright or dorsal recumbent position with the head of the bed at 30-45 degrees, according to participant's preference. Pillows were placed under the head, under the shoulder where the tube was located, and under the arms, according to the participant's preference. In order to keep the abdominal muscles relaxed, femur and knee flexion was provided.
  7. PolySomnioGraph (PSG) was placed on the participant for sleep measurement. The participant's satisfaction about the position was questioned. The room lights were turned off, and noise-causing factors were removed.
  8. In the morning, the PolySomnnioGraph (PSG) connections were removed from the participant and pain was questioned and rated again.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •being in the 18-70 age group (adult age group accepted for pain perception and sleep)
  • •being operated on by the same surgical team
  • •having a posterolateral thoracotomy technique
  • •having the same anesthesia and analgesia protocol
  • •being transferred from the intensive care unit to the clinic at the 48th hour after thoracotomy
  • •having a single chest tube inserted (placed under the 1-2nd intercostal space of the thoracotomy incision, in the mid-axillary line)
  • •having a rigid drainage tube with a diameter of 28-32 Fr
  • •having a chest tube inserted for the first time.

排除标准

  • •rib fracture
  • •pneumonectomy and decortication
  • •previous thoracic surgery and radiotheraphy
  • •having a diagnosis of a major neurological problem (as it may affect pain perception and sleep)
  • •having a diagnosed sleep problem
  • •a diagnosis of substance or alcohol dependency requiring treatment
  • •any musculoskeletal problem that prevents positioning in bed

研究组 & 干预措施

The Position to Prevent Pleural Irritation (PPPI) Group

Experimental

The participants in the Position to Prevent Pleural Irritation (PPPI) group were positioned in bed in order to minimize pleural irritation caused by the contact of the chest tube with the pleura during sleep.

干预措施: The Position to Prevent Pleural Irritation (PPPI) (Behavioral)

Routine care

No Intervention

Participants in the control group received routine care in the clinical procedure. Participants assumed their desired in-bed position for sleep.

结局指标

主要结局

Pain Level

时间窗: Pain scoring: The first pain scoring was be done on the patient's first day at the clinic before giving the Pleural Irritation Prevention Position at bedtime. The second pain scoring was be done at the first hour when the patient wakes up in the morning

McGill Pain Questionnaire Short-Form was used for pain assessment. The Verbal Pain Scale, contained in the McGill Pain Questionnaire Short-Form, measured pain intensity at the four-hour mark rating pain of 0 - 5 with 0 = no pain, 1 = mild pain, 2 = discomforting pain, 3 distressing pain, 4 = horrible pain and 5 = excruciating pain.

Sleep quality

时间窗: Sleep quality: The first sleep quality scoring was be done on the patient's first day of hospitalization, before sleep hour (22:00-23:00 pm). The second measurement was made between 06:00 and 07:00 (am) of the night spent in the Pleural Irritation Preven

Sleep quality was evaluated with the Richard-Campbell Sleep Questionnaire (RCSQ). Scores between "0-25" indicate very poor sleep quality, and scores between "76-100" indicate very good sleep quality.

Sleep efficiency

时间窗: Sleep efficiency: Sleep efficiency measurement was made between 06:00 and 07:00 (am) of the night spent in the Pleural Irritation Prevention Position.

Sleep efficiency during one night's sleep was measured with a polysomniograph device. Sleep efficiency was evaluated between "0-100" and a value between "85-100" was considered effective sleep.

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

Emine Kol

Professor

Akdeniz University

研究点 (1)

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