Clinical trial NCT06919978: Position to Prevent Pleural Irritation (PPPI) for Pain and Sleep
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chest Tube
Thoracotomy
Pain
Sleep
Keywords: Thoracic surgery
Pleural irritation
Chest tube irritation
Sleep quality
Pain control
Positioning in bed
Lead sponsor: Akdeniz University
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study was conducted in a non-randomized, single-blind, quasi-experimental design.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain Level
timeFrame: 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
measure: Sleep quality
timeFrame: 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
measure: Sleep efficiency
timeFrame: Sleep efficiency: Sleep efficiency measurement was made between 06:00 and 07:00 (am) of the night spent in the Pleural Irritation Prevention Position.
Secondary outcomes:
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University Faculty of Nursing
state: Konyaltı
Study officials:
affiliation: Head of Nursing Department
name: Emine Kol, Professor
role: STUDY_CHAIR
References:
citation: Charnock Y, Evans D. Nursing management of chest drains: a systematic review. Aust Crit Care. 2001 Nov;14(4):156-60. doi: 10.1016/s1036-7314(05)80058-x.
citation: Lavigne, G. (2007). S15. A Pain perception during sleep. Sleep Medicine, (8), S21.
citation: Bastuji, H. (2017). S167 Sensory workup during NONREM sleep. Clinical Neurophysiology, 128(9), e232.
citation: Baranwal N, Yu PK, Siegel NS. Sleep physiology, pathophysiology, and sleep hygiene. Prog Cardiovasc Dis. 2023 Mar-Apr;77:59-69. doi: 10.1016/j.pcad.2023.02.005. Epub 2023 Feb 24.
citation: Fox V, Gould D, Davies N, Owen S. Patients' experiences of having an underwater seal chest drain: a replication study. J Clin Nurs. 1999 Nov;8(6):684-92. doi: 10.1046/j.1365-2702.1999.00307.x.
citation: Batchelor TJP, Rasburn NJ, Abdelnour-Berchtold E, Brunelli A, Cerfolio RJ, Gonzalez M, Ljungqvist O, Petersen RH, Popescu WM, Slinger PD, Naidu B. Guidelines for enhanced recovery after lung surgery: recommendations of the Enhanced Recovery After Surgery (ERAS(R)) Society and the European Society of Thoracic Surgeons (ESTS). Eur J Cardiothorac Surg. 2019 Jan 1;55(1):91-115. doi: 10.1093/ejcts/ezy301.