the Participant Wishes to Leave the StudyNCT06404710
Progressive Muscle Relaxation Exercise Applied After Heart Surgery
A study testing Exercise in people with the Participant Wishes to Leave the Study, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
Various methods are used to prolong life and improve quality of life in heart diseases. There are surgical treatment options. Heart surgery is a major surgery and surgery Due to common postoperative symptoms, follow-up and follow-up in the early postoperative period maintenance is important.Progressive relaxation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- the Participant Wishes to Leave the Study
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Oct 2023to 20 Jun 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteer to participate in the study,
- Those who are 18 years of age and over,
- Those who underwent coronary bypass graft surgery
- Communication difficulties and mental disability regarding vision, hearing and speech non,
- Blood pressure measurement does not need to be done on an outpatient basis,
- Any postoperative complications (bleeding, nausea, vomiting, etc.) not occurring,
Show all 12Show fewer
- Analgesic medication should be administered before the first intervention planned to be performed after the surgery.
- not implemented,
- Any medication etc. without substance addiction,
- Does not have chronic pain in any part of the body,
- Those who were extubated after cardiac surgery and were not given sedating medication
- All non-pregnant patients will be included in the sample.
Who cannot join
- Any symptoms such as severe bleeding, nausea or vomiting after the surgical procedure.
- developing complications,
- Patient-controlled analgesia (PCA) for pain control after surgery applied
- Those with deformity in the chest area,
- Preoperative respiratory function test is not within normal limits,
- Patients with Chronic Obstructive Pulmonary Disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Progressive Muscle Relaxation Exercises Applied After Heart Surgery on Anxiety, Pain, Sleep and Effect on Healing Quality
Various methods are used to prolong life and improve quality of life in heart diseases.
There are surgical treatment options. Heart surgery is a major surgery and surgery Due to common postoperative symptoms, follow-up and follow-up in the early postoperative period maintenance is important.Progressive relaxation exercise; optimization of analgesia, pain management, reduction of side effects, regulation of vital signs, increase in sleep qualityIt has been reported that it provides positive effects on many systems and increases the success of the surgical process. It has been stated in research that it can increase.In this study, patients who had undergone cardiac surgery and were treated as inpatients progressive muscle relaxation in reducing pain, reducing anxiety, and improving the quality of sleep and recovery It was aimed to determine the effect of the exercises.
Read the detailed description
In the literature reviews, it has been determined that the treatment applied to patients after cardiac surgery. A study examining the effects of progressive muscle relaxation exercise on pain, sleep and recovery quality. No study was found. This study shows that progressive muscle relaxation exercise affects pain, sleep and Its effect on the quality of recovery will be evaluated. Progressive muscle relaxation after heart surgery. If the exercises are found to be effective, they should be implemented routinely in the surgical ward. will be recommended. With this study, cardiac surgery is included in the literature in the field of surgical nursing.
The application of progressive muscle relaxation exercises after surgery has a significant effect on pain, recovery quality andIt is aimed to contribute with findings regarding its effect on sleep quality. of nurses using nonpharmacological methods in clinics; professional of the nursing profession It will increase their practice, independent role and quality of care. After heart surgery. Reducing postoperative pain and anxiety with progressive muscle relaxation exercises, It is thought that it may be useful in improving sleep quality and recovery quality.
- Being tested
- Exercise
- Keywords
- progressive muscle relaxation, anxiety, quality of recovery, heart surgery, sleep, pain
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Participants in this group will be given a gradual muscle relaxation exercise.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Scales will be filled in for the control group without any progressive relaxation exercise. |
| Exercise | Experimental | Scales will be filled in by the intervention group by performing a progressive relaxation exercise. Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
NUMERICAL RATING SCALE
This scale contains numbers from 1 to 10. 1: not at all, 10: very much. Patients' pain will be measured.
Measured: First day before surgery, first 4 days after surgery and 20 days after discharge
VISUAL COMPARISON SLEEP SCALE
Each item in the scale is evaluated using a visual comparison technique on a graph between 0 (left end) and 100 (right end), the minimum score that can be obtained from the scale is 0 and the maximum score is 1000. An increase in the score obtained from the scale indicates that sleep quality decreases. It consists of 15 items in total.
Measured: 3rd day after surgery and 20 days after discharge
State Anxiety Scale
Anxiety level is scored as "(1) not at all, (2) a little, (3) a lot and (4) completely". The scores obtained from the scale theoretically range between 20 and 80. A high score indicates a high level of anxiety.
Measured: 3rd day after surgery and 20 days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start18 Oct 2023
- Primary completion1 Jun 2024 (estimated)
- Study completion20 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for the Participant Wishes to Leave the StudyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled (experimental and control group)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Çığla Arslankılıç, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404710
- Sponsor's protocol ID
- 2023/26
- Status last verified
- May 2024
- First submitted
- 30 Apr 2024
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Progressive Muscle Relaxation Exercises Applied After Heart Surgery on Anxiety, Pain, Sleep and Effect on Healing Quality
- ClinicalTrials.gov ID
- NCT06404710
- Acronym / sponsor ID
- 2023/26
- Keywords
- progressive muscle relaxation, anxiety, quality of recovery, heart surgery, sleep, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 1 Jun 2024 (estimated)
- Study completion
- 20 Jun 2024 (estimated)
- First posted
- 8 May 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.
Various methods are used to prolong life and improve quality of life in heart diseases.
There are surgical treatment options. Heart surgery is a major surgery and surgery Due to common postoperative symptoms, follow-up and follow-up in the early postoperative period maintenance is important.Progressive relaxation exercise; optimization of analgesia, pain management, reduction of side effects, regulation of vital signs, increase in sleep qualityIt has been reported that it provides positive effects on many systems and increases the success of the surgical process. It has been stated in research that it can increase.In this study, patients who had undergone cardiac surgery and were treated as inpatients progressive muscle relaxation in reducing pain, reducing anxiety, and improving the quality of sleep and recovery It was aimed to determine the effect of the exercises.
Detailed description
In the literature reviews, it has been determined that the treatment applied to patients after cardiac surgery. A study examining the effects of progressive muscle relaxation exercise on pain, sleep and recovery quality. No study was found. This study shows that progressive muscle relaxation exercise affects pain, sleep and Its effect on the quality of recovery will be evaluated. Progressive muscle relaxation after heart surgery. If the exercises are found to be effective, they should be implemented routinely in the surgical ward. will be recommended. With this study, cardiac surgery is included in the literature in the field of surgical nursing.
The application of progressive muscle relaxation exercises after surgery has a significant effect on pain, recovery quality andIt is aimed to contribute with findings regarding its effect on sleep quality. of nurses using nonpharmacological methods in clinics; professional of the nursing profession It will increase their practice, independent role and quality of care. After heart surgery. Reducing postoperative pain and anxiety with progressive muscle relaxation exercises, It is thought that it may be useful in improving sleep quality and recovery quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized controlled (experimental and control group)
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Scales will be filled in for the control group without any progressive relaxation exercise. |
| Exercise | Experimental | Behavioral: ExerciseScales will be filled in by the intervention group by performing a progressive relaxation exercise. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Volunteer to participate in the study,
- Those who are 18 years of age and over,
- Those who underwent coronary bypass graft surgery
- Communication difficulties and mental disability regarding vision, hearing and speech non,
- Blood pressure measurement does not need to be done on an outpatient basis,
Key exclusion criteria (6 listed)
- Any symptoms such as severe bleeding, nausea or vomiting after the surgical procedure.
- developing complications,
- Patient-controlled analgesia (PCA) for pain control after surgery applied
- Those with deformity in the chest area,
- Preoperative respiratory function test is not within normal limits,
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 |
|---|---|---|
| ExerciseParticipants in this group will be given a gradual muscle relaxation exercise. | Behavioural | Exercise |
Primary outcome
NUMERICAL RATING SCALE
Time frame: First day before surgery, first 4 days after surgery and 20 days after discharge
This scale contains numbers from 1 to 10. 1: not at all, 10: very much. Patients' pain will be measured.
VISUAL COMPARISON SLEEP SCALE
Time frame: 3rd day after surgery and 20 days after discharge
Each item in the scale is evaluated using a visual comparison technique on a graph between 0 (left end) and 100 (right end), the minimum score that can be obtained from the scale is 0 and the maximum score is 1000. An increase in the score obtained from the scale indicates that sleep quality decreases. It consists of 15 items in total.
State Anxiety Scale
Time frame: 3rd day after surgery and 20 days after discharge
Anxiety level is scored as "(1) not at all, (2) a little, (3) a lot and (4) completely". The scores obtained from the scale theoretically range between 20 and 80. A high score indicates a high level of anxiety.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with the Participant Wishes to Leave the Study, run by Saglik Bilimleri Universitesi 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 12 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
NUMERICAL RATING SCALE (time frame: First day before surgery, first 4 days after surgery and 20 days after discharge). The study lists 3 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 8 May 2024.