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

NCT06919978 | Completed DMC

• 1 other identifier: TSA-2018-3765
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Tube; Thoracotomy; Pain; Sleep

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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

• 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.

  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 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.

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

Study Arms (2)

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.

Behavioral: The Position to Prevent Pleural Irritation (PPPI)

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.

Interventions

The Position to Prevent Pleural Irritation (PPPI) BEHAVIORAL

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.

The Position to Prevent Pleural Irritation (PPPI) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Akdeniz University: lead

Study Sites (1)

Akdeniz University Faculty of Nursing

Antalya, Konyaltı, 07058, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 11806513 BACKGROUND

• Lavigne, G. (2007). S15. A Pain perception during sleep. Sleep Medicine, (8), S21.

  BACKGROUND

• Bastuji, H. (2017). S167 Sensory workup during NONREM sleep. Clinical Neurophysiology, 128(9), e232.

  BACKGROUND

• 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.

  PMID: 36841492 BACKGROUND

• 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.

  PMID: 10827615 BACKGROUND

• 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.

  PMID: 30304509 BACKGROUND

MeSH Terms

Conditions

Pain; Sleep Initiation and Maintenance Disorders; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations

Study Officials

• Emine Kol, Professor

  Head of Nursing Department

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The study was conducted in a non-randomized, single-blind, quasi-experimental design.

Study Record Dates

• First Submitted: February 1, 2025
• First Posted: April 9, 2025
• Study Start: June 20, 2018
• Primary Completion: January 16, 2020
• Study Completion: June 30, 2021
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)