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

April 2, 2025 updated by: Emine Kol, Akdeniz University

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.

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Konyaltı
      • Antalya, Konyaltı, Turkey, 07058
        • Akdeniz University Faculty of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Level
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
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
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
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
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Emine Kol, Professor, Head of Nursing Department

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2018

Primary Completion (Actual)

January 16, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 1, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

April 9, 2025

Last Update Submitted That Met QC Criteria

April 2, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Since the study results have not yet been published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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