Chest TubeNCT06919978

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

A study testing The Position to Prevent Pleural Irritation (PPPI) in people with Chest Tube and Thoracotomy, run by Akdeniz University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Chest Tube, Thoracotomy, Pain
What is being tested?: The Position to Prevent Pleural Irritation (PPPI)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 20 Jun 2018to 30 Jun 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Akdeniz University Faculty of Nursing
Antalya, Konyaltı, 07058

Other trials in Turkey (Türkiye)

About this study

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.

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)

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.
When the participants were admitted to the thoracic surgery clinic, information about positioning and sleep measurement was given by the researcher.
The researcher questioned and evaluated the patient's pain before bedtime, and routine analgesic were applied.
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.
The position and working order of the chest drainage system and drainage tube were checked.
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.
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.
In the morning, the PolySomnnioGraph (PSG) connections were removed from the participant and pain was questioned and rated again.

Conditions: Chest Tube, Thoracotomy, Pain, Sleep
Being tested: The Position to Prevent Pleural Irritation (PPPI)
Keywords: Thoracic surgery, Pleural irritation, Chest tube irritation, Sleep quality, Pain control, Positioning in bed
Medical subject headings: Pain, Sleep Initiation and Maintenance Disorders, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The Position to Prevent Pleural Irritation (PPPI)Behavioural
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.

Study groups in NCT06919978
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Jun 201830 Jun 2021

First posted9 Apr 2025
Study start20 Jun 2018
Primary completion16 Jan 2020
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Chest TubeStudies of the same condition, open and under way.
More trials run by Akdeniz UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Model description: The study was conducted in a non-randomized, single-blind, quasi-experimental design.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06919978
Sponsor's protocol ID: TSA-2018-3765
Status last verified: Apr 2025
First submitted: 1 Feb 2025
Last updated: 9 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Since the study results have not yet been published.

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chest Tube trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT06919978
Acronym / sponsor ID: TSA-2018-3765
Conditions: Chest Tube, Thoracotomy, Pain, Sleep
Keywords: Thoracic surgery, Pleural irritation, Chest tube irritation, Sleep quality, Pain control, Positioning in bed
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Akdeniz UniversityUniversity, hospital or other
Study start: 20 Jun 2018 (actual)
Primary completion: 16 Jan 2020 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 9 Apr 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Position to Prevent Pleural Irritation (PPPI)

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.
When the participants were admitted to the thoracic surgery clinic, information about positioning and sleep measurement was given by the researcher.
The researcher questioned and evaluated the patient's pain before bedtime, and routine analgesic were applied.
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.
The position and working order of the chest drainage system and drainage tube were checked.
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.
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.
In the morning, the PolySomnnioGraph (PSG) connections were removed from the participant and pain was questioned and rated again.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The study was conducted in a non-randomized, single-blind, quasi-experimental design.

Arm	Type	Receives
The Position to Prevent Pleural Irritation (PPPI) Group	Experimental	Behavioral: The Position to Prevent Pleural Irritation (PPPI)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.
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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The 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.	Behavioural	The Position to Prevent Pleural Irritation (PPPI) Group

Primary outcome

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.
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 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.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2025.
Background: PubMed 11806513Charnock 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.
BackgroundLavigne, G. (2007). S15. A Pain perception during sleep. Sleep Medicine, (8), S21.
BackgroundBastuji, H. (2017). S167 Sensory workup during NONREM sleep. Clinical Neurophysiology, 128(9), e232.
Background: PubMed 36841492Baranwal 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.
Background: PubMed 10827615Fox 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.
Background: PubMed 30304509Batchelor 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.
Individual participant dataSharing planned: No. Since the study results have not yet been published.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Emine Kol, Professor study chair

Head of Nursing Department

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The Position to Prevent Pleural Irritation (PPPI) in people with Chest Tube and Thoracotomy, run by Akdeniz University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06919978, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2025.