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

NCT ID: NCT06919978

Last Updated: 2025-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-20

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Chest Tube Thoracotomy Pain Sleep

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

The study was conducted in a non-randomized, single-blind, quasi-experimental design.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

The Position to Prevent Pleural Irritation (PPPI)

Intervention Type 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.

Routine care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akdeniz University

OTHER

Sponsor Role lead

Responsible Party

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Emine Kol

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Emine Kol, Professor

Role: STUDY_CHAIR

Head of Nursing Department

Locations

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Akdeniz University Faculty of Nursing

Antalya, Konyaltı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 11806513 (View on PubMed)

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

Reference Type BACKGROUND

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

Reference Type 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.

Reference Type BACKGROUND
PMID: 36841492 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10827615 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30304509 (View on PubMed)

Other Identifiers

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TSA-2018-3765

Identifier Type: -

Identifier Source: org_study_id

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