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

NCT03375723 | Completed

• 1 other identifier: FoU in VGR 235991
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism

Keywords

Pain measurement; Pain

Outcome Measures

Primary Outcomes (2)

• Respiratory associated pain estimated with Visual Analogue Scale (VAS).

  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.

  Daily during the whole study period of 14 days.

• Analgesic consumption

  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.

  Daily during the whole study period of 14 days.

Secondary Outcomes (4)

• Frequency use of breathing technique.

  Daily during the whole study period of 14 days.

• Lung function measurement with Peak Expiratory Flow (PEF)

  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.

• Questions about patients self-efficacy on coping with pain

  The questions are asked by a protocol on the day of inclusion, day 7 and day 14.

• Functional index estimated with Disability Rating Index (DRI).

  Estimation takes place on the day of inclusion, day 7 and day 14.

Other Outcomes (3)

• Number of Days hospitalized

  Registration of the outcome takes place at the day for discharge from hospital with a maximal admission time of 14 days.

• Pneumonia frequency

  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.

• Oxygen saturation of the blood

  Daily, once a day during hospitalization. If the time hospitalized exceeds 14 days then the last day for registration is day 14.

Study Arms (2)

Information on anatomy and physiology, and breathing technique

EXPERIMENTAL

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

Usual care treatment

ACTIVE COMPARATOR

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

Interventions

Information on anatomy and physiology, and breathing technique OTHER

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.

Information on anatomy and physiology, and breathing technique

Usual care treatment OTHER

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.

Usual care treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between 18 and 80 years of age that understands oral and written instructions in Swedish
• Presence of respiratory associated chest pain from a verified acute pulmonary embolism.
• Presence 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41345, Sweden

Location

MeSH Terms

Conditions

Pulmonary Embolism; Pain

Interventions

Functional Status

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Monika Fagevik Olsén, Professor

  Göteborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 6, 2017
• First Posted: December 18, 2017
• Study Start: October 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

SE (1)