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

NCT03375723 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-02-29

No results posted yet for this study

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.

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Göteborg University

    lead OTHER

Principal Investigators

  • Monika Fagevik Olsén, Professor · Göteborg University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-01
Primary Completion
2023-12-31
Completion
2024-01-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03375723 on ClinicalTrials.gov