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Effects of Information and Breathing Technique - for Patients With Respiratory Pain in Acute Pulmonary Embolism.

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ClinicalTrials.gov Identifier: NCT03375723
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : April 24, 2019
Sponsor:
Collaborator:
The Renée Eander Foundation
Information provided by (Responsible Party):
Göteborg University

Brief Summary:

Acute pulmonary embolism (PE) is a serious disease and the third most common cardiovascular disease following myocardial infarction and stroke. The most common symptoms of acute PE are breathlessness and respiratory pain. Although many patients have respiratory pain in acute PE, the treatment of pain is not well described in literature. It is also unclear how long after acute PE the respiratory pain persists. In other conditions with respiratory associated pain, clinical treatment guidelines are available to avoid complications, such as pneumonia, related to impaired respiratory function.

The purpose of this randomized controlled multicenter study is to evaluate the effect of a treatment, in patients with respiratory associated acute PE pain, consisting of information on anatomy and physiology in acute PE and breathing technique in addition to usual care treatment. The above treatment will be compared to conventional treatment in PE with respiratory associated pain, which means treatment with analgesics.

One hundred sixty patients recruited from the Sahlgrenska University Hospital and Alingsås Hospital will participate in the study.

Both groups are examined before and after interventions related to respiratory associated pain, measured with visual analogue scale (VAS), analgesic consumption, lung function measured with Peak Expiratory Flow (PEF), physical disability impairment measured by Disability Rating Index (DRI) and questions about the patients self-efficacy on managing their respiratory associated pain, days hospitalized, pneumonia rate during or after hospitalization, oxygen saturation and patient satisfaction.

Both groups are followed from the inclusion date to 14 days after inclusion through physical visits by the physiotherapist during hospital care and by telephone contact after discharge.

If the positive clinical experience of the information and breathing technique can be confirmed in the study, the method could be spread and used as an easily accessible new treatment method.


Condition or disease Intervention/treatment Phase
Pulmonary Embolism Other: Information on anatomy and physiology, and breathing technique Other: Usual care treatment Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A randomized, controlled, intervention study. Evaluation of the addition of information and breathing technique for patients with respiratory associated chest pain in acute pulmonary embolism compared to standard care
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Information and Breathing Technique - for Patients With Respiratory Associated Chest Pain in Acute Pulmonary Embolism. A Randomized, Controlled Multicenter Study.
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : January 14, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Information on anatomy and physiology, and breathing technique

Information on anatomy and physiology, and breathing technique

  • Information about anatomy
  • Information about physiology
  • Breathing technique
Other: Information on anatomy and physiology, and breathing technique
The patients in the treatment group receive information about what acute PE is regarding anatomy and physiology, a review of what causes the respiratory associated pain in acute PE and also a review of the breathing technique to manage their respiratory associated pain. The given information is standardized and the patient also receives written information with both text and pictures. Patients in the treatment group will meet the physiotherapist at day 1, 2 and the patients also has an opportunity to see the physiotherapist or talk to her at the phone if there are any questions concerning the study.

Active Comparator: Usual care treatment
Usual care treatment given to patients with respiratory associated pain in acute PE, which is treatment with analgesics. The information on anatomy and physiology in acute PE is the usual information given by the physician at the ward that the patient is treated.
Other: Usual care treatment
Usual care treatment given to patients with respiratory associated pain in acute PE, which is treatment with analgesics. The information on anatomy and physiology in acute PE is the usual information given by the physician at the ward that the patient is treated.




Primary Outcome Measures :
  1. Respiratory associated pain estimated with Visual Analogue Scale (VAS). [ Time Frame: Daily during the whole study period of 14 days. ]
    Self-assessment of pain intensity of respiratory associated pain according to VAS (scale 0-10, "no pain" vs. "worst possible pain"). Pain intensity is estimated by the patient after moving from lying to sitting and taking three deep breaths. Estimation once a day of average pain during the day is estimated throughout the entire study period. VAS is an instrument for self-estimation of pain which in studies has proven to be both valid and reliable in estimating acute pain.

  2. Analgesic consumption [ Time Frame: Daily during the whole study period of 14 days. ]
    Daily consumption of analgesics is recorded in the study protocol via the patient record. When the patient is discharged from hospital, the patient registers what type of analgesics the patient has taken and in what amount in the study protocol.


Secondary Outcome Measures :
  1. Frequency use of breathing technique. [ Time Frame: Daily during the whole study period of 14 days. ]

    Patients in the treatment group register the frequency of the use of the breathing technique during the whole day.

    The registration of breathing techniques is divided into sections where, 1-3 times, 4-6 times, 7-10 times or more than 11 times a day, are the different options. Measurement once a day throughout the study period.


  2. Lung function measurement with Peak Expiratory Flow (PEF) [ Time Frame: Measurement takes place on the day of inclusion and at the day for discharge from hospital. If the patient is not discharged within 14 days, the measurement takes place at day 14. ]
    A measurement of the patient's ability to breathe out his/hers air three times is tested using a PEF-device. The measurement is an objective measure of the patient's ability to create a maximum airflow value during expiration, which may identify possible airway obstruction.

  3. Questions about patients self-efficacy on coping with pain [ Time Frame: The questions are asked by a protocol on the day of inclusion, day 7 and day 14. ]

    Patients will respond to three claims of confidence in their own ability to cope with their pain.

    The claims are rated from "Not sure" to "Absolutely safe" on a 100-millimeter horizontal line and are:

    • How sure are you on your ability to reduce your respiratory associated pain significantly?
    • How sure are you that you can achieve a small to moderate decrease in your respiratory associated pain by means other than increased medication?
    • How sure are you that you can achieve a significant reduction in your respiratory associated pain by means other than increased medication? The questions used are chosen from a scale of self-efficacy and are used exploratively to seek more knowledge of the patients own experience of managing the pain associated with acute LE.

  4. Functional index estimated with Disability Rating Index (DRI). [ Time Frame: Estimation takes place on the day of inclusion, day 7 and day 14. ]

    The patient estimates his/hers perceived physical impairment in performing twelve different physical activities from making simpler activities to exercise physically strenuous activities.

    The patient estimates his ability to perform the activity from "manage without difficulty" to "unable to perform" on a horizontal line that is 100 mm long. DRI is an instrument commonly used for patients with musculoskeletal disabilities. For this patient group, DRI has proven to have both high validity and reliability. DRI has also been used for patients with stable coronary artery disease and has also demonstrated good reliability in the assessment of physical function.



Other Outcome Measures:
  1. Number of Days hospitalized [ Time Frame: Registration of the outcome takes place at the day for discharge from hospital with a maximal admission time of 14 days. ]
    Registration on how many days the patient has been admitted to hospital care due to acute pulmonary embolism.

  2. Pneumonia frequency [ Time Frame: The patient is asked if he/she have had a pneumonia after falling ill with acute pulmonary embolism. The question is asked at day 14 over the telephone through a Day-14-follow-up-protocol. ]
    The rate of patients that develops a pneumonia after having acute pulmonary embolism.

  3. Oxygen saturation of the blood [ Time Frame: Daily, once a day during hospitalization. If the time hospitalized exceeds 14 days then the last day for registration is day 14. ]
    Registration of the patients oxygen saturation by a puls oximeter device.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients between 18 and 80 years of age that understands oral and written instructions in Swedish
  • Presens of respiratory associated chest pain from a verified acute pulmonary embolism.
  • Presens of respiratory associated pain after moving from a lying to a seated position and taken three deep breaths
  • At the time of assessment of pain estimate his/hers pain to >30 mm on the Visual Analogue Scale.

Exclusion Criteria:

  • Serious physical illness that includes thorax ie. trauma, lung cancer or rheumatological disease
  • Serious non-treated psychiatric disease including psychiatric and psychological disease which are the main cause to the patients pain
  • Severe alcohol- or substance abuse
  • Treatment with opioids before the diagnosis of acute pulmonary embolism. -Prolonged cancer/ non-cancer related pain.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03375723


Contacts
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Contact: Monika Fagevik Olsén, Professor +46313421195 monika.fagevik-olsen@vgregion.se
Contact: Jenny S Danielsbacka, MSc +46313427076 jenny.danielsbacka@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Göteborg, Västra Götaland, Sweden, 41345
Contact: Monika Fagevik Olsén, Professor    +46313421195    monika.fagevik-olsen@vgregion.se   
Contact: Jenny Danielsbacka, MSc    +46313427076    jenny.danielsbacka@vgregion.se   
Sponsors and Collaborators
Göteborg University
The Renée Eander Foundation
Investigators
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Principal Investigator: Monika Fagevik Olsén, Professor Göteborg University

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Responsible Party: Göteborg University
ClinicalTrials.gov Identifier: NCT03375723     History of Changes
Other Study ID Numbers: FoU in VGR 235991
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Göteborg University:
Pain measurement
Pain
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Respiratory Tract Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases