PainNCT06726239
Progressive Relaxation Exercises Before Mobilization:Effects on Pain, Anxiety and Physiologic Parameters CABG Patients
A study testing Progressive relaxation exercises in people with Pain and Anxiety, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery. Read more about this study
- Who is it for?
- Ages 35 to 65 years
- Conditions the study is for
- Pain, Anxiety, Physiological Parameter
- What is being tested?
- Progressive relaxation exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2024to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability to read and write in Turkish,
- Analgesics given ≥4h before assessment,
- Conscious and communicative,
- Elective coronary artery bypass graft surgery planned,
- Patients undergoing coronary artery bypass graft surgery for the first time were included in the study.
Who cannot join
- Diagnosed with a psychiatric or neurological disorder,
- Diagnosis of a musculoskeletal condition that could affect mobilization,
- Patients with hearing and vision loss,
- Patients participating in another clinical trial during the same period,
- Patients who developed any complications during the postoperative period were excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kartal Koşuyolu Yüksek İhtisas Eğitim ve Araştırma Hastanesi
Istanbul, Istanbul, 34320
Tuğçe Bozkurt, 05063137927, tgcebzkurtt@gmail.com
About this study
Official title: The Effect of Progressive Relaxation Exercises Applied Before Mobilization on Pain, Anxiety and Physiological Parameters in Patients With Coronary Artery Bypass Graft Surgery
This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery.
Read the detailed description
This study was planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises on pain, anxiety and physiological parameters before mobilization in patients undergoing coronary artery bypass graft (CABG) surgery. Ethics committee and institutional approval were obtained before starting the study. Patients were informed about the study and their verbal and written informed consent was obtained. The study will be conducted in a public hospital in Istanbul with 68 patients (experimental group = 34, control group = 34) who met the research criteria and underwent CABG surgery. The patients in the experimental group will be given progressive relaxation exercises twice at 6-hour intervals on postoperative day 1 and day 2. Patients in the control group will receive routine treatment and care. Physiological parameters, pain, and anxiety levels will be evaluated twice daily on postoperative days 1 and 2 in both groups.It was also stated that a smart wristband should be worn on the arms of the patients on postoperative days 1 and 2 to monitor the frequency of mobilization in both the experimental and control groups. In addition, the frequency of analgesic use will be monitored.
- Conditions
- Pain, Anxiety, Physiological Parameter, Mobilization, Coronary Artery Bypass Graft Surgery (CABG), PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Being tested
- Progressive relaxation exercises
- Keywords
- coronary artery bypass graft surgery, pain, Anxiety, progressive relaxation exercise, physiological parameter
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive relaxation exercisesOther
The aim of relaxation exercises is to help individuals recognize the difference between tension and relaxation and to enable them to relax in situations of stress. These exercises are performed with light background music and verbal instructions, allowing patients to mentally focus on the process. The progressive relaxation technique involves the voluntary contraction and subsequent relaxation of muscle groups, typically starting from the hands and progressing to the feet, with each muscle group activated in sequence. During the exercise, the instructions and steps from the 'Relaxation Exercises' CD published by the Turkish Psychologists Association will be followed.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention | No intervention | In the preoperative period, patients in the control group completed the Patient Demographic Information Form and the Trait Anxiety Inventory. Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance. Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were evaluated at pre-test, 30 minutes later, and 15 minutes after mobilization. Additionally, pain intensity was assessed immediately after mobilization. On postoperative days 1 and 2, all assessments were conducted twice daily. The frequency of analgesic administration was also monitored. |
| Experimental | Experimental | In the preoperative period, patients completed the Patient Demographic Information Form and the Trait Anxiety Inventory. Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance. Furthermore, patients in the intervention group received video-assisted training on diaphragmatic breathing and progressive muscle relaxation (PMR) exercises.
In the intervention group, PMR was performed twice a day on postoperative days 1 and 2. Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were measured at pre-test, 5 minutes after each PMR session, and 15 minutes after mobilization. Additionally, pain intensity was assessed immediately after mobilization. The frequency of analgesic administration was also monitored. Receives: Other: Progressive relaxation exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Characteristics Form
The first part includes questions about demographic characteristics such as gender, age, body mass index (height-weight), marital status, education level, income level and occupation, and the second part includes questions about other chronic diseases, previous surgery, previous stay in the intensive care unit, smoking and alcohol use.
Measured: Preoperative
Trait Anxiety Inventory
The Trait Anxiety Inventory is used to determine how the individual "usually" feels and the items of the scale are scored between 1-4 points (1=almost never, 2=sometimes, 3=very often, 4=almost always). There are 7 reversed statements in the trait anxiety subscale (items 21, 26, 27, 30, 33, 36 and 39).
Measured: Preoperative
Physiological parameters monitoring
Physiological parameters will be monitored.
Measured: Postoperative Day 1:(measured twice, 6-hour apart): Control: Pre-test, 30 min later, 15 min post-mobilization Experimental: Pre-test, 5 min post-PGE, 15 min post-mobilization. Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
State Anxiety Inventory
It is used to determine how the individual feels "right now" and the items of the scale are scored between 1-4 points (1=not at all, 2=somewhat, 3=very much, 4=completely).
Measured: Postop Day 1:(measured twice, 6-hour apart): Control: Pre-test,30 minutes after,15 min post-mobilization.Experimental: Pre-test, 5 minutes after PGE, 15 min post-mobilization.Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
Short Form McGill Pain Questionnaire
The scale consists of three parts in which the nature of pain, intensity of pain and overall pain intensity are evaluated.
Measured: Postop1:Measured twice at 6h:Control:Pre-test, 30 min later, post-mobilization vas, 15 min post-mobilization. Experimental: Pre-test, 5 min post-PGE, post-mobilization vas, 15 min post-mobilization.Postop2: Both groups:Measured twice at 6-hour intervals
Secondary outcomes (2)
Mobilization Schedule
Mobilization will be assessed on postoperative days 1 and 2 based on the number of steps taken, distance covered, and relevant features of the mobilization process.
Measured: Postoperative day 1 and 2
Analgesia monitoring form
In this form prepared by the researcher in line with the literature, the name, dose, time and route of administration will be recorded in case of analgesic use of the patients.
Measured: Postoperative day 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start31 May 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- experiment-control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tugce Bozkurt Elmas, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726239
- Sponsor's protocol ID
- 1308
- Status last verified
- Jun 2025
- First submitted
- 2 Dec 2024
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the ethical approval for the study and the informed consent obtained from participants do not include permission to share data with third parties. Additionally, the responsibility to protect participant privacy and data confidentiality prevents such sharing.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercises Applied Before Mobilization on Pain, Anxiety and Physiological Parameters in Patients With Coronary Artery Bypass Graft Surgery
- ClinicalTrials.gov ID
- NCT06726239
- Acronym / sponsor ID
- 1308
- Conditions
- Pain, Anxiety, Physiological Parameter, Mobilization, Coronary Artery Bypass Graft Surgery (CABG), PROGRESSIVE MUSCLE RELAXATION EXERCISES
- Keywords
- coronary artery bypass graft surgery, pain, Anxiety, progressive relaxation exercise, physiological parameter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery.
Detailed description
This study was planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises on pain, anxiety and physiological parameters before mobilization in patients undergoing coronary artery bypass graft (CABG) surgery. Ethics committee and institutional approval were obtained before starting the study. Patients were informed about the study and their verbal and written informed consent was obtained. The study will be conducted in a public hospital in Istanbul with 68 patients (experimental group = 34, control group = 34) who met the research criteria and underwent CABG surgery. The patients in the experimental group will be given progressive relaxation exercises twice at 6-hour intervals on postoperative day 1 and day 2. Patients in the control group will receive routine treatment and care. Physiological parameters, pain, and anxiety levels will be evaluated twice daily on postoperative days 1 and 2 in both groups.It was also stated that a smart wristband should be worn on the arms of the patients on postoperative days 1 and 2 to monitor the frequency of mobilization in both the experimental and control groups. In addition, the frequency of analgesic use will be monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- experiment-control
| Arm | Type | Receives |
|---|---|---|
| No Intervention | No intervention | –In the preoperative period, patients in the control group completed the Patient Demographic Information Form and the Trait Anxiety Inventory. Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance. Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were evaluated at pre-test, 30 minutes later, and 15 minutes after mobilization. Additionally, pain intensity was assessed immediately after mobilization. On postoperative days 1 and 2, all assessments were conducted twice daily. The frequency of analgesic administration was also monitored. |
| Experimental | Experimental | Other: Progressive relaxation exercisesIn the preoperative period, patients completed the Patient Demographic Information Form and the Trait Anxiety Inventory. Patients were preoperatively informed about wearing a smart bracelet on postoperative days 1 and 2 to track step count and walking distance. Furthermore, patients in the intervention group received video-assisted training on diaphragmatic breathing and progressive muscle relaxation (PMR) exercises. In the intervention group, PMR was performed twice a day on postoperative days 1 and 2. Physiological parameters, state anxiety, and pain levels (Short-Form McGill Pain Questionnaire) were measured at pre-test, 5 minutes after each PMR session, and 15 minutes after mobilization. Additionally, pain intensity was assessed immediately after mobilization. The frequency of analgesic administration was also monitored. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability to read and write in Turkish,
- Analgesics given ≥4h before assessment,
- Conscious and communicative,
- Elective coronary artery bypass graft surgery planned,
- Patients undergoing coronary artery bypass graft surgery for the first time were included in the study.
Key exclusion criteria (5 listed)
- Diagnosed with a psychiatric or neurological disorder,
- Diagnosis of a musculoskeletal condition that could affect mobilization,
- Patients with hearing and vision loss,
- Patients participating in another clinical trial during the same period,
- Patients who developed any complications during the postoperative period were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive relaxation exercisesThe aim of relaxation exercises is to help individuals recognize the difference between tension and relaxation and to enable them to relax in situations of stress. These exercises are performed with light background music and verbal instructions, allowing patients to mentally focus on the process. The progressive relaxation technique involves the voluntary contraction and subsequent relaxation of muscle groups, typically starting from the hands and progressing to the feet, with each muscle group activated in sequence. During the exercise, the instructions and steps from the 'Relaxation Exercises' CD published by the Turkish Psychologists Association will be followed. | Other | Experimental |
Primary outcome
Descriptive Characteristics Form
Time frame: Preoperative
The first part includes questions about demographic characteristics such as gender, age, body mass index (height-weight), marital status, education level, income level and occupation, and the second part includes questions about other chronic diseases, previous surgery, previous stay in the intensive care unit, smoking and alcohol use.
Trait Anxiety Inventory
Time frame: Preoperative
The Trait Anxiety Inventory is used to determine how the individual "usually" feels and the items of the scale are scored between 1-4 points (1=almost never, 2=sometimes, 3=very often, 4=almost always). There are 7 reversed statements in the trait anxiety subscale (items 21, 26, 27, 30, 33, 36 and 39).
Physiological parameters monitoring
Time frame: Postoperative Day 1:(measured twice, 6-hour apart): Control: Pre-test, 30 min later, 15 min post-mobilization Experimental: Pre-test, 5 min post-PGE, 15 min post-mobilization. Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
Physiological parameters will be monitored.
State Anxiety Inventory
Time frame: Postop Day 1:(measured twice, 6-hour apart): Control: Pre-test,30 minutes after,15 min post-mobilization.Experimental: Pre-test, 5 minutes after PGE, 15 min post-mobilization.Postoperative Day 2: Both groups:Same measurements at 6-hour intervals, twice
It is used to determine how the individual feels "right now" and the items of the scale are scored between 1-4 points (1=not at all, 2=somewhat, 3=very much, 4=completely).
Short Form McGill Pain Questionnaire
Time frame: Postop1:Measured twice at 6h:Control:Pre-test, 30 min later, post-mobilization vas, 15 min post-mobilization. Experimental: Pre-test, 5 min post-PGE, post-mobilization vas, 15 min post-mobilization.Postop2: Both groups:Measured twice at 6-hour intervals
The scale consists of three parts in which the nature of pain, intensity of pain and overall pain intensity are evaluated.
2 secondary outcomes
Mobilization Schedule
Time frame: Postoperative day 1 and 2
Analgesia monitoring form
Time frame: Postoperative day 1 and 2
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the ethical approval for the study and the informed consent obtained from participants do not include permission to share data with third parties. Additionally, the responsibility to protect participant privacy and data confidentiality prevents such sharing.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive relaxation exercises in people with Pain and Anxiety, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tuğçe Bozkurt (05063137927, tgcebzkrt55@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Characteristics Form (time frame: Preoperative). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2025.