Pain Level, Sleep Quality and Analgesic Consumption in Open Heart SurgeryNCT05727280
The Effect of Progressive Relaxation Exercise on Pain Level, Sleep Quality and Analgesic Consumption
A study testing Progressive Relaxation Exercise Practices in people with Pain Level, Sleep Quality and Analgesic Consumption in Open Heart Surgery, run by Suleyman Demirel University at 1 site in Turkey (Türkiye).
Trial summary
Coronary artery bypass graft (CABG) surgery is the process of providing re-oxygenation of the myocardium by anastomosis to the occluded heart coronary with the graft created using certain vessels of the body. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Pain Level, Sleep Quality and Analgesic Consumption in Open Heart Surgery
- What is being tested?
- Progressive Relaxation Exercise Practices
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jan 2023to 5 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having undergone open heart surgery and heart valve surgery
- Being extubated within the first 4 hours after CABG and heart valve surgery
- Being transfer to service within 48-72 hours after CABG and heart valve surgery
- Being between 30 and 85 years old
- Having ability to read, write and speak Turkish
- Being conscious and oriented
Show all 11Show fewer
- Having no problems communication
- Not experiencing any psychological discomfort
- Having no problems with seeing, hearing, speaking and expressing oneself
- No complications before, during and three days after surgery
- Beeing volunteer and agree to participate in research
Who cannot join
- Having a speech and hearing problem that prevents the understanding of the given information and the application of PRE
- Presence of diagnosed neurological or psychiatric disease
- Being a foreign national
- Being unconscious in the pre- and postoperative period
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Suleyman Demirel University Hospital
Isparta, Isparta, 32000
About this study
Official title: The Effect of Progressive Relaxation Exercise on Pain Level, Sleep Quality and Analgesic Consumption of Patients Undergoing Open Heart Surgery: a Randomized Controlled Study
Coronary artery bypass graft (CABG) surgery is the process of providing re-oxygenation of the myocardium by anastomosis to the occluded heart coronary with the graft created using certain vessels of the body. After CABG surgery, pain occurs due to thoracic surgical incision, surgical incision in the saphenous vein or radial artery regions for grafting. Pain that is not well managed in the post-operative period also increases the analgesic consumption of the patients. When pain management is inadequate, the patient's recovery process is affected by causing limitation in movements, digestive, circulatory, respiratory system and sleep problems in the postoperative period.
Progressive relaxation exercise (PRE) is an application that provides relaxation and relaxation as a result of conscious contraction and relaxation of large muscle groups in the body, and increasing body awareness in the individual. PRE is among the preferred non-pharmacological applications today in terms of being inexpensive, harmless, easily administered by the patient, positively affecting the patient's functions and reducing their complaints. Studies have generally evaluated the effectiveness of pharmacological (analgesic) methods in order to reduce postoperative pain. Although analgesics are indispensable in the management of postoperative pain, they may not always be sufficient to reduce the patient's pain sufficiently. Also, analgesics have some undesirable side effects. For this reason, it is reported that the use of non-pharmacological methods together with pharmacological methods increases the effectiveness of pharmacological methods in order to reduce the pain experienced by the patients after the surgical intervention and to reduce the complaints that occur in the patient due to pain. For this reason, various analgesic combinations and non-pharmacological methods should be used together to reduce postoperative pain. In this direction, PRE has become a technique frequently used and preferred by nurses in pain management in recent years.
The PGE technique, developed by Jacobson in 1929, is based on the idea that anxiety-provoking thoughts and events create physiological tension. PGE is the conscious contraction and relaxation of large muscle groups in the body, and noticing the change in between. PGE can be performed one-on-one or as a group in one or several sessions with the help of a CD or audio recorder. It can be applied with musical accompaniment, visual imagery or diaphragmatic breathing to increase its effectiveness. The exercise can be done from head to foot or from foot to head. In this study, it was aimed to investigate the effect of progressive relaxation exercise on postoperative pain level, sleep quality and analgesic consumption in patients undergoing open heart surgery.
Read the detailed description
One of the non-pharmacological treatment methods that can provide therapeutic benefit for pain management and improving sleep quality is Progressive relaxation exercise (PRE). The PRE is the conscious contraction and relaxation of large muscle groups in the body, and noticing the change (Demir Burcu, 2013; Genç and Oğuz, 2018; Oğuz et al., 2019). The PRE technique, developed by Jacobson in 1929, is based on the idea that anxiety-provoking thoughts and events create physiological tension (Blanaru, 2012). Jacobson developed the PRE to raise awareness of skeletal muscle tension. Muscle tension is triggered by various negative emotions and psychosomatic diseases. With this exercise, relaxation is aimed to reduce the feeling of tension and the perceived stress level (Genç \& Oğuz, 2018; Oğuz et al., 2019). The PRE; it is an inexpensive method that can be easily taught by nurses, yoga instructors, clinical psychologists, and other complementary alternative medicine practitioners. The PRE can be performed one-on-one or as a group in one or several sessions with the help of a CD or audio recorder. It can be applied with musical accompaniment, visual imagery or diaphragmatic breathing in order to increase its effectiveness (Genç and Oğuz, 2018; Oğuz et al., 2019). The PRE involves sequentially stretching and relaxing all 16 muscle groups as you breathe in. The exercise can be from head to foot or from foot to head. During the exercise, the patient must complete the processes of perceiving the tension in his body, maintaining control and being able to go into a state of relaxation. After the patient is informed about the exercise, he starts with breathing exercises. A deep but relaxing breath is taken through the nose, and simultaneously with the relaxation, the lips are contracted and breath given through the mouth. During this application, the patient keeps the muscle group he is working in for 10 seconds; the nurse, on the other hand, enables the patient to notice the warmth/warming felt in the muscle group (Demiralp, 2006; Demiralp \& Oflaz, 2007; Ratfisch, 2015; Demiralp \& Oflaz, 2011; Özveren, 2011; Eyüpoğlu, 2013). In order for PRE to be effective, there must be no factors that can warn the patient, and the room must be dim, airy and at a suitable temperature. During the exercise, the patient is asked to sit in a comfortable chair or lie on his back. Effective work does not occur because it is loaded on some muscle groups in the side or prone position. The patient should be physically and mentally comfortable. In order to achieve this, the clothes should be chosen loosely and there should be no items (belt, buckle, glasses, etc.) that will tighten the body. In the mental sense; It should be ensured that he can focus on a tool (sound, word, object, etc.) in order to get away from the bad thoughts in his mind (Yıldırım, 1991; McCallie et al., 2006; Özveren, 2011).
In this study, it is aimed to evaluate the effect of progressive relaxation exercise applied to patients undergoing cardiac surgery on pain level, sleep quality and analgesic consumption. In addition, it is thought that the results obtained from this study will increase awareness of progressive relaxation exercise and other similar applications as a cheap, easy, effective, applicable and easily adaptable non-pharmacological method in patients undergoing cardiac surgery. The research hypotheses are:
- Progressive relaxation exercise have an effect on pain level in patients undergoing open heart surgery.
- Progressive relaxation exercise have an effect on sleep quality in patients undergoing open heart surgery.
- Progressive relaxation exercise have an effect on analgesic consumption in patients undergoing open heart surgery.
- There is a difference between the pain level, sleep quality and analgesic consumption of the patients who underwent open heart surgery in the intervention group, in which progressive relaxation exercise was applied, and in the control group, which was not applied progressive relaxation exercise.
- Being tested
- Progressive Relaxation Exercise Practices
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Relaxation Exercise PracticesBehavioural
The intervention planned within the scope of the research are the Progressive Relaxation Exercise application. Patients in the intervention group undergoing open heart surgery will be given training on progressive relaxation exercise in the patient's room the day before the surgery. Correct breathing techniques will be taught and the relaxation exercises will be performed by using audio recordings. Afterwards, the relaxation exercise will be provided to the patient to practice the progressive relaxation exercise with mp3 accompaniment. After open heart surgery, progressive relaxation exercise will be applied to the patient on the 1st, 2nd and 3rd days of his admission to the service. The patient will be asked to perform the progressive relaxation exercise twice a day, once during the day and once in the evening.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | After the first meeting with the patients in the intervention group, the patients will be informed about the application of the Progressive Relaxation Exercise and the exercise application will be taught. After open heart surgery, progressive relaxation exercise will be applied to the patient on the 1st, 2nd and 3rd days of his admission to the service. The patient will be asked to perform the progressive relaxation exercise twice a day, once during the day and once in the evening. Before each daytime application, the score given by the patient to the SF-MPQ will be recorded. Patients will be asked to repeat the same application two hours after dinner. In the morning of the next day after each application, the score given by the patient to the RCSQ will be recorded by the researcher. Receives: Behavioral: Progressive Relaxation Exercise Practices |
| Control Group | No intervention | After the first meeting with the patients in the control group, the routine care and treatment practices planned by the service will continue. No additional intervention is planned for the patients in this group. After open heart surgery, patients will be asked to fill out the SF-MPQ and RCSQ on the 1st, 2nd and 3rd days of the patient's admission to the service. After the completion of the study, progressive relaxation exercise training will be given to the patients in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Critical-Care Pain Observation Tool (CPOT)
Critical-Care Pain Observation Tool (CPOT) will be used to determine the pain intensity of the participants in the intensive care unit. The CPOT Gèlinas et al. was developed by at 2007. The Turkish validity and reliability study of the scale was performed by Gündoğan et al. made by at 2016. The scale includes four subscales, including facial expression, muscle tension, body movements, and compliance with ventilation in intubated patients, and behavioral items consisting of sounds made in extubated patients. Each of the subscales of the scale is evaluated between 0-2 points and the total score of the scale varies between 0-8. The intensive care pain observation scale can be used both in patients who can communicate verbally and in intubated and deep sedation situation. The CPOT is a valid and reliable scale to evaluate the pain of intensive care patients. Scores above 2 in the CPOT indicate that the patient is experiencing pain.
Measured: within 48-72 hours of patients staying in intensive care
Secondary outcomes (2)
Short Form McGill Pain Questionnaire (SF-MPQ)
Short Form McGill Pain Questionnaire (SF-MPQ), which was developed by Melzack in 1987, provides information about the sensory characteristics of the pain, the severity of pain and its effects. Its validity and reliability in our country Yakut et al. by performed at 2007. It includes three different sections within the SF-MPQ.
First Part (pain form): This part includes words that give information about the nature of the pain felt. In this part of the scale, a total of three pain scores are obtained: sensory pain score, perceptual pain score and total pain score.
Second Part (current pain index): This part includes five different word groups that can range from "mild pain" to "unbearable pain" to determine the severity of the pain described by the patient.
Third Part (pain scale score): Individuals are asked to mark on a 10 cm long scale in the visual analog part of the pain intensity, taking into account the current severity of the pain felt.
Measured: The 1st, 2nd and 3rd days of the patient's in the service after open heart surgery
Richard-Campbell Sleep Questionnaire (RCSQ)
Richard-Campbell Sleep Questionnaire (RCSQ) was developed in 1987 to describe sleep problems experienced at night. The scale consists of 6 questions that measure the characteristics of the previous night's sleep (depth of night sleep, time to fall asleep, frequency of awakening, time to stay awake when awakened, sleep quality and noise level in the environment). The first 5 questions are included in the scale scoring, and the 6th question is excluded from the scoring. Each item in the scale is evaluated on a scale between 0 and 100, increasing with 5-point intervals (0-5-10-15-.....-90-95-100). If the scores obtained from the scale are between "0-25", it indicates very poor sleep quality, and between "76-100" indicates very good sleep quality. The higher the score, the higher the sleep quality. The validity and reliability of the scale in our country; It was made by Özlü and Özer at 2015.
Measured: The 1st, 2nd and 3rd days of the patient's in the service after open heart surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start23 Jan 2023
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Level, Sleep Quality and Analgesic Consumption in Open Heart SurgeryStudies 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
- The research is a randomized controlled single-blind quasi-experimental research design.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suleyman Demirel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamze Bolattürk, Suleyman Demirel University
- Investigators
- Gamze Bolattürk, Principal investigator, Suleyman Demirel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727280
- Sponsor's protocol ID
- GBolatturk
- Status last verified
- Jan 2025
- First submitted
- 3 Feb 2023
- Last updated
- 4 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Progressive Relaxation Exercise on Pain Level, Sleep Quality and Analgesic Consumption of Patients Undergoing Open Heart Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05727280
- Acronym / sponsor ID
- GBolatturk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Suleyman Demirel UniversityUniversity, hospital or other
- Study start
- 23 Jan 2023 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 14 Feb 2023 (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.
Coronary artery bypass graft (CABG) surgery is the process of providing re-oxygenation of the myocardium by anastomosis to the occluded heart coronary with the graft created using certain vessels of the body. After CABG surgery, pain occurs due to thoracic surgical incision, surgical incision in the saphenous vein or radial artery regions for grafting. Pain that is not well managed in the post-operative period also increases the analgesic consumption of the patients. When pain management is inadequate, the patient's recovery process is affected by causing limitation in movements, digestive, circulatory, respiratory system and sleep problems in the postoperative period.
Progressive relaxation exercise (PRE) is an application that provides relaxation and relaxation as a result of conscious contraction and relaxation of large muscle groups in the body, and increasing body awareness in the individual. PRE is among the preferred non-pharmacological applications today in terms of being inexpensive, harmless, easily administered by the patient, positively affecting the patient's functions and reducing their complaints. Studies have generally evaluated the effectiveness of pharmacological (analgesic) methods in order to reduce postoperative pain. Although analgesics are indispensable in the management of postoperative pain, they may not always be sufficient to reduce the patient's pain sufficiently. Also, analgesics have some undesirable side effects. For this reason, it is reported that the use of non-pharmacological methods together with pharmacological methods increases the effectiveness of pharmacological methods in order to reduce the pain experienced by the patients after the surgical intervention and to reduce the complaints that occur in the patient due to pain. For this reason, various analgesic combinations and non-pharmacological methods should be used together to reduce postoperative pain. In this direction, PRE has become a technique frequently used and preferred by nurses in pain management in recent years.
The PGE technique, developed by Jacobson in 1929, is based on the idea that anxiety-provoking thoughts and events create physiological tension. PGE is the conscious contraction and relaxation of large muscle groups in the body, and noticing the change in between. PGE can be performed one-on-one or as a group in one or several sessions with the help of a CD or audio recorder. It can be applied with musical accompaniment, visual imagery or diaphragmatic breathing to increase its effectiveness. The exercise can be done from head to foot or from foot to head. In this study, it was aimed to investigate the effect of progressive relaxation exercise on postoperative pain level, sleep quality and analgesic consumption in patients undergoing open heart surgery.
Detailed description
One of the non-pharmacological treatment methods that can provide therapeutic benefit for pain management and improving sleep quality is Progressive relaxation exercise (PRE). The PRE is the conscious contraction and relaxation of large muscle groups in the body, and noticing the change (Demir Burcu, 2013; Genç and Oğuz, 2018; Oğuz et al., 2019). The PRE technique, developed by Jacobson in 1929, is based on the idea that anxiety-provoking thoughts and events create physiological tension (Blanaru, 2012). Jacobson developed the PRE to raise awareness of skeletal muscle tension. Muscle tension is triggered by various negative emotions and psychosomatic diseases. With this exercise, relaxation is aimed to reduce the feeling of tension and the perceived stress level (Genç \& Oğuz, 2018; Oğuz et al., 2019). The PRE; it is an inexpensive method that can be easily taught by nurses, yoga instructors, clinical psychologists, and other complementary alternative medicine practitioners. The PRE can be performed one-on-one or as a group in one or several sessions with the help of a CD or audio recorder. It can be applied with musical accompaniment, visual imagery or diaphragmatic breathing in order to increase its effectiveness (Genç and Oğuz, 2018; Oğuz et al., 2019). The PRE involves sequentially stretching and relaxing all 16 muscle groups as you breathe in. The exercise can be from head to foot or from foot to head. During the exercise, the patient must complete the processes of perceiving the tension in his body, maintaining control and being able to go into a state of relaxation. After the patient is informed about the exercise, he starts with breathing exercises. A deep but relaxing breath is taken through the nose, and simultaneously with the relaxation, the lips are contracted and breath given through the mouth. During this application, the patient keeps the muscle group he is working in for 10 seconds; the nurse, on the other hand, enables the patient to notice the warmth/warming felt in the muscle group (Demiralp, 2006; Demiralp \& Oflaz, 2007; Ratfisch, 2015; Demiralp \& Oflaz, 2011; Özveren, 2011; Eyüpoğlu, 2013). In order for PRE to be effective, there must be no factors that can warn the patient, and the room must be dim, airy and at a suitable temperature. During the exercise, the patient is asked to sit in a comfortable chair or lie on his back. Effective work does not occur because it is loaded on some muscle groups in the side or prone position. The patient should be physically and mentally comfortable. In order to achieve this, the clothes should be chosen loosely and there should be no items (belt, buckle, glasses, etc.) that will tighten the body. In the mental sense; It should be ensured that he can focus on a tool (sound, word, object, etc.) in order to get away from the bad thoughts in his mind (Yıldırım, 1991; McCallie et al., 2006; Özveren, 2011).
In this study, it is aimed to evaluate the effect of progressive relaxation exercise applied to patients undergoing cardiac surgery on pain level, sleep quality and analgesic consumption. In addition, it is thought that the results obtained from this study will increase awareness of progressive relaxation exercise and other similar applications as a cheap, easy, effective, applicable and easily adaptable non-pharmacological method in patients undergoing cardiac surgery. The research hypotheses are:
- Progressive relaxation exercise have an effect on pain level in patients undergoing open heart surgery.
- Progressive relaxation exercise have an effect on sleep quality in patients undergoing open heart surgery.
- Progressive relaxation exercise have an effect on analgesic consumption in patients undergoing open heart surgery.
- There is a difference between the pain level, sleep quality and analgesic consumption of the patients who underwent open heart surgery in the intervention group, in which progressive relaxation exercise was applied, and in the control group, which was not applied progressive relaxation exercise.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- The research is a randomized controlled single-blind quasi-experimental research design.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Progressive Relaxation Exercise PracticesAfter the first meeting with the patients in the intervention group, the patients will be informed about the application of the Progressive Relaxation Exercise and the exercise application will be taught. After open heart surgery, progressive relaxation exercise will be applied to the patient on the 1st, 2nd and 3rd days of his admission to the service. The patient will be asked to perform the progressive relaxation exercise twice a day, once during the day and once in the evening. Before each daytime application, the score given by the patient to the SF-MPQ will be recorded. Patients will be asked to repeat the same application two hours after dinner. In the morning of the next day after each application, the score given by the patient to the RCSQ will be recorded by the researcher. |
| Control Group | No intervention | –After the first meeting with the patients in the control group, the routine care and treatment practices planned by the service will continue. No additional intervention is planned for the patients in this group. After open heart surgery, patients will be asked to fill out the SF-MPQ and RCSQ on the 1st, 2nd and 3rd days of the patient's admission to the service. After the completion of the study, progressive relaxation exercise training will be given to the patients in the control group. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Having undergone open heart surgery and heart valve surgery
- Being extubated within the first 4 hours after CABG and heart valve surgery
- Being transfer to service within 48-72 hours after CABG and heart valve surgery
- Being between 30 and 85 years old
- Having ability to read, write and speak Turkish
Key exclusion criteria (4 listed)
- Having a speech and hearing problem that prevents the understanding of the given information and the application of PRE
- Presence of diagnosed neurological or psychiatric disease
- Being a foreign national
- Being unconscious in the pre- and postoperative period
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 Exercise PracticesThe intervention planned within the scope of the research are the Progressive Relaxation Exercise application. Patients in the intervention group undergoing open heart surgery will be given training on progressive relaxation exercise in the patient's room the day before the surgery. Correct breathing techniques will be taught and the relaxation exercises will be performed by using audio recordings. Afterwards, the relaxation exercise will be provided to the patient to practice the progressive relaxation exercise with mp3 accompaniment. After open heart surgery, progressive relaxation exercise will be applied to the patient on the 1st, 2nd and 3rd days of his admission to the service. The patient will be asked to perform the progressive relaxation exercise twice a day, once during the day and once in the evening. | Behavioural | Intervention Group |
Primary outcome
Critical-Care Pain Observation Tool (CPOT)
Time frame: within 48-72 hours of patients staying in intensive care
Critical-Care Pain Observation Tool (CPOT) will be used to determine the pain intensity of the participants in the intensive care unit. The CPOT Gèlinas et al. was developed by at 2007. The Turkish validity and reliability study of the scale was performed by Gündoğan et al. made by at 2016. The scale includes four subscales, including facial expression, muscle tension, body movements, and compliance with ventilation in intubated patients, and behavioral items consisting of sounds made in extubated patients. Each of the subscales of the scale is evaluated between 0-2 points and the total score of the scale varies between 0-8. The intensive care pain observation scale can be used both in patients who can communicate verbally and in intubated and deep sedation situation. The CPOT is a valid and reliable scale to evaluate the pain of intensive care patients. Scores above 2 in the CPOT indicate that the patient is experiencing pain.
2 secondary outcomes
Short Form McGill Pain Questionnaire (SF-MPQ)
Time frame: The 1st, 2nd and 3rd days of the patient's in the service after open heart surgery
Richard-Campbell Sleep Questionnaire (RCSQ)
Time frame: The 1st, 2nd and 3rd days of the patient's in the service after open heart surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Gamze Bolattürk principal investigator
Suleyman Demirel University
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 Exercise Practices in people with Pain Level, Sleep Quality and Analgesic Consumption in Open Heart Surgery, run by Suleyman Demirel University 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 11 inclusion and 4 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: finished, as of the sponsor's last update on 4 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Critical-Care Pain Observation Tool (CPOT) (time frame: within 48-72 hours of patients staying in intensive care). 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 4 Feb 2025.