- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06889935
Investigating the Effect of Respiratory Exercise Diary on Pain in Cardiovascular Surgery
March 26, 2025 updated by: Melisa Köse, Marmara University
The Effect of Respiratory Exercise Diary Use on Postoperative Pain in Patients Undergoing Cardiovascular Surgery
The study was carried out to evaluate the effect of respiratory exercise diary use on postoperative pain in patients undergoing elective cardiovascular surgery in a training and research hospital in Istanbul.
Study Overview
Detailed Description
The randomised controlled experimental study was conducted between 11 July 2024 and 11 January 2025 in the cardiovascular surgery inpatient wards of a training and research hospital in Istanbul.
The study was conducted with a total of 74 patients, 37 in the control group and 37 in the intervention group.
Data were collected by the researcher through face-to-face interviews with the patients.
'Patient Identification Form', "Visual Analogue Scale (VAS)", "Respiratory Exercise Diary" were used.
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maltepe
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İstanbul, Maltepe, Turkey, 34854
- Marmara Univesity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- No barriers to verbal communication (mental, physiological and psychological)
- Patients undergoing elective cardiovascular surgery,
- Individuals who agreed to participate in the study,
- Patients whose haemodynamics are suitable for respiratory exercise
Exclusion Criteria:
- Being in the intensive care unit after surgical intervention,
- Patients undergoing re-operation after surgical intervention,
- Those who do not accept the study or who want to leave during the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group using a respiratory exercise diary (intervention group)
All of the patients included in the group were asked to fill in the 'Patient Identification Form' and pain assessment was performed with 'Visual Analogue Scale (VAS)'.
Information was given about respiratory exercises and spirometry, which is routinely used in the postoperative period in patients undergoing cardiovascular surgery in the hospital where the study was conducted.
Respiratory Exercise Diary was introduced to this group and its use was demonstrated practically.
They were asked to record the exercises performed in this diary.
Pain assessment was performed with Visual Analogue Scale for the first 3 days after surgery.
On the 1st postoperative day, this group was informed again about respiratory exercises, spirometer and its daily use, and the first exercises and records were made together with the researcher.
They were asked to continue the exercises and recordings themselves for the first 3 days.
|
The respiratory exercise diary was prepared by reviewing the literature in order to record the time, number and frequency of respiratory exercises performed by patients with the use of a spirometer.
On the first page of the diary consisting of two pages; the patient's name and surname, date of surgery, date of birth, how and how often to use the spirometer, and a pictorial information note to remind the position to be taken were included, while on the second page; the chart in which the patients would write the number of exercises they performed with the spirometer during the first three postoperative days opposite the relevant hour was included.
Other Names:
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No Intervention: Group not using a respiratory exercise diary (control group)
'Patient Identification Form' was filled out for all patients and pain assessment was performed with 'Visual Analogue Scale (VAS)'.
Information was given about respiratory exercises and spirometry, which is routinely used in the postoperative period in patients undergoing cardiovascular surgery in the hospital where the study was conducted.
This group was asked to note the exercises on a piece of paper.
Pain assessment was performed with Visual Analogue Scale in the first 3 days postoperatively.
On the 1st postoperative day, the information about breathing exercises and recording procedures was repeated and the practices continued in the routine functioning of the clinic.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual analogue scale (VAS)
Time Frame: four days
|
VAS is a very common scale used for pain assessment in daily practice and in this assessment, pain averages ranging from 0 to 10 are given on a 10 cm straight line in a horizontal or vertical plane.
In the scale used to determine the pain intensity of patients, pain is graded between 0 (no pain) and 10 (unbearable pain).
Accordingly, while '0' indicates no pain, an average VAS value of less than 3 indicates mild pain, 3-6 indicates mild-moderate pain, and greater than 6 indicates moderate-severe pain.
VAS is an accepted scale in the world literature that visually describes pain intensity, provides ease of use and consists of a single question.
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four days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Melisa KÖSE TUNÇ, Student, Marmara University
- Principal Investigator: Hamdiye B. KATRAN, Asst. Prof., Marmara University
- Principal Investigator: Mehmet E. MEMETOĞLU, Assoc. Prof., Dr. Siyami Ersek Training and Research Hospital Department of Cardiovascular Surgery
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 11, 2024
Primary Completion (Actual)
January 11, 2025
Study Completion (Actual)
January 21, 2025
Study Registration Dates
First Submitted
March 16, 2025
First Submitted That Met QC Criteria
March 16, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
April 1, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- MARU-SBF-MKT-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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