CClinicalTrials.gg
Sign In
CompletedNCT06919978Updated Apr 9, 2025

Position to Prevent Pleural Irritation (PPPI) for Pain and Sleep

An interventional study of The Position to Prevent Pleural Irritation (PPPI) in Chest Tube, Thoracotomy and Pain, sponsored by Akdeniz University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Akdeniz University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 6 years 7 months after the study started (first participant enrolled Jun 2018, registered Feb 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Chest Tube
  • Thoracotomy
  • Pain
  • Sleep

Keywords

  • Thoracic surgery
  • Pleural irritation
  • Chest tube irritation
  • Sleep quality
  • Pain control
  • Positioning in bed
03

In context

Lead sponsor

Akdeniz University is the lead sponsor of 289 studies on the registry; 60 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
60 participants (actual)

Study arms

  • Experimental
    The Position to Prevent Pleural Irritation (PPPI) Group

    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.

    Behavioral: The Position to Prevent Pleural Irritation (PPPI)

  • No intervention
    Routine care

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

Interventions

  • BehavioralThe Position to Prevent Pleural Irritation (PPPI)

    The Position to Prevent Pleural Irritation (PPPI) was administered once before sleep on the first night of the day the participant arrived at the clinic.

06

What researchers measure

Primary outcomes

  1. Pain Level

    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.

    Time frame: 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

  2. Sleep quality

    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.

    Time frame: 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

  3. Sleep efficiency

    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.

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

07

Study locations

1 site
  • Akdeniz University Faculty of Nursing
    Antalya, Konyaltı 07058, Turkey
08

References and documents

Publications

  • 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. PubMed 11806513 ↗
  • Lavigne, G. (2007). S15. A Pain perception during sleep. Sleep Medicine, (8), S21.
  • Bastuji, H. (2017). S167 Sensory workup during NONREM sleep. Clinical Neurophysiology, 128(9), e232.
  • 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. PubMed 36841492 ↗
  • 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. PubMed 10827615 ↗
  • 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. PubMed 30304509 ↗

Individual participant data

Plan to share: No — Since the study results have not yet been published.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06919978
Lead sponsor
Akdeniz University
Responsible party
Emine Kol (Professor, Akdeniz University) — Principal investigator
First posted
Apr 9, 2025
Start date
Jun 20, 2018
Primary completion
Jan 16, 2020
Completion
Jun 30, 2021
Last update
Apr 9, 2025

Study contacts

Emine Kol, Professor
study chair · Head of Nursing Department

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Akdeniz University

Start the discussion