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CompletedNCT06889935Updated Apr 1, 2025

Investigating the Effect of Respiratory Exercise Diary on Pain in Cardiovascular Surgery

An interventional study of Exercise diary in Cardiovascular Surgery, sponsored by Marmara University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-01.

Sponsored by Marmara University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jul 2024, registered Mar 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
74
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the 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.

02

Conditions studied

  • Cardiovascular Surgery

Keywords

  • Cardiovascular surgery
  • exercise diary
  • nursing care
  • pain
  • postoperative pain
  • postoperative period
  • respiratory exercise
  • spirometer
03

In context

Lead sponsor

Marmara University is the lead sponsor of 576 studies on the registry; 136 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
74 participants (actual)

Study arms

  • 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.

    Other: Exercise diary

  • 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.

Interventions

  • OtherExercise diary

    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.

    Also known as: Respiratory exercise diary

06

What researchers measure

Primary outcomes

  1. Visual analogue scale (VAS)

    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.

    Time frame: four days

07

Study locations

1 site
  • Marmara Univesity
    İstanbul, Maltepe 34854, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06889935
Lead sponsor
Marmara University
Responsible party
Melisa Köse (Principal Investigator, Marmara University) — Principal investigator
First posted
Mar 21, 2025
Start date
Jul 11, 2024
Primary completion
Jan 11, 2025
Completion
Jan 21, 2025
Last update
Apr 1, 2025

Study contacts

Melisa KÖSE TUNÇ, Student
principal investigator · Marmara University
Hamdiye B. KATRAN, Asst. Prof.
principal investigator · Marmara University
Mehmet E. MEMETOĞLU, Assoc. Prof.
principal investigator · Dr. Siyami Ersek Training and Research Hospital Department of Cardiovascular Surgery

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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