Nursing CariesNCT05446662
The Effect of Complementary Care Model on Patient Outcomes
A study testing music therapy, aromatherapy and Progressive Relaxation Exercises in people with Nursing Caries and Music Therapy, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
The study will be carried out in Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital Cardiovascular Surgery Clinic between January 2022 and February 2023. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Nursing Caries, Music Therapy, Aromatherapy
- What is being tested?
- music therapy, aromatherapy and Progressive Relaxation Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2022to 25 Dec 2023
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have undergone coronary bypass surgery with a beating heart-off pump,
- Those who are classified as I, II and III according to the system that the American Society of Anesthesiologists (ASA) classifies by evaluating patients according to their physical health status before surgery,
- Patients who do not have respiratory problems and are not allergic to plants
- Those without cognitive impairment,
- Those who can speak and communicate in Turkish and agree to participate in the study,
- Patients with a body mass ratio of 30 and below,
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- Those who do not have chronic pain, alcohol, drug and substance addiction,
- Those who do not have Covid 19 disease,
- Patients with systolic blood pressure above 95 mmHg,
- It was planned to include patients who had planned surgery and did not develop complications during or after the surgery.
Who cannot join
- Patients undergoing coronary bypass surgery using a cardiopulmonary bypass machine,
- Those who are classified as ASA IV, V and IV,
- Patients who could not be reached before surgery,
- People with asthma and allergies to plants
- Those with mental disorders (psychosis, dementia, delirium),
- Hearing, vision, speech, smell disorders,
Show all 12Show fewer
- Those who do not speak Turkish, cannot communicate and do not agree to participate in the research,
- Patients with a body mass ratio above 30,
- Those with chronic pain, alcohol, drug and substance addiction,
- Having had a covid 19 disease,
- Patients with systolic blood pressure below 95 mmHg,
- Patients who underwent emergency surgery and had serious complications during and after surgery will not be included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal Training and Research Hospital
Bolu
About this study
Official title: The Effect of Complementary Care Model on Patient Outcomes in Patients With Coronary Artery Bypass
The study will be carried out in Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital Cardiovascular Surgery Clinic between January 2022 and February 2023.
The population of the study will consist of patients who will undergo coronary artery bypass in a planned heart and meet the inclusion criteria.
Read more
The sample of the study will consist of patients who meet the inclusion criteria, volunteer to participate in the study, and whose written consent has been obtained.
To calculate the sample size of the study; NCSS Pass 11.0 program was used. According to the result calculated in this program, it was seen that a total of 60 people, 30 people in each group, should be reached for two groups and 99% power (α: 0.05).
With this study, it is aimed to increase the job satisfaction and quality of nurses as well as to increase the satisfaction of the patients in terms of nursing.
By presenting the Complementary Care Model to our country for the first time with this study; In this context, it was planned to determine the effects of music therapy, progressive muscle relaxation exercise, aromatherapy and massage on the outcomes (nausea, vomiting, sleep, anxiety, pain, complications and satisfaction) of coronary artery bypass graft patients.
Read the detailed description
Patients in the post-randomization application group will choose one or more of music therapy, aromatherapy, progressive relaxation exercises and massage therapies according to the predisposing factors, facilitating factors and health care needs in choosing these applications according to the complementary care model.
Before the application, data will be collected from the patients with an introductory form containing the demographic data of the patients, Visual Pain Scale (VAS), and State Anxiety Scale.
Vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature and respiratory rate) before and after the operation (10., 30. and 60. min), before and again on the 2nd and 3rd days after the operation. It will be measured and recorded after the application (10th, 30th, and 60th minutes).
After the preoperative practices, vital signs will be measured and the Surgery-Specific Anxiety Scale will be filled in by face-to-face interview method.
On the 1st and 2nd postoperative days, after each application, the VAS, the state anxiety scale, the visual comparison scale to evaluate the satisfaction level of the patients from the interventions after the 2nd postoperative day applications, and the Richard-Campell Sleep Scale to evaluate the night's sleep of the individual will be used.
Complications seen in the patient will be recorded on the patient follow-up form while the patients are discharged.
Routine pre- and post-operative nursing care will be given to the patients in the control group after randomization.
Data will be collected from the patients with an introductory form including their preoperative demographic data, Visual Pain Scale (VAS), and State Anxiety Scale.
Vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature and respiratory rate) before and after the operation (10., 30. and 60. min), before and again on the 2nd and 3rd days after the operation. It will be measured and recorded after the application (10th, 30th, and 60th minutes).
- Conditions
- Nursing Caries, Music Therapy, Aromatherapy, Preoperative Care, Postoperative Care, Complementary Therapies
- Being tested
- music therapy, aromatherapy, Progressive Relaxation Exercises, Hand massage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music therapyOther
Patients participating in the study will be informed about the application of music therapy in the preoperative period. The patients who will take part in the music group are given 30 minutes the day before the surgery, and 30 minutes a day on the 1st and 2nd days after the surgery. Music that is selected by the researcher and grouped as relaxing music, classical music, sufi music and Turkish folk music will be played. The patients will be listened to the music with headphones that cover the whole ear, and the music will be adjusted to make them feel comfortable.
aromatherapyOther
Patients participating in the study will be informed about the application of aromatherapy in the preoperative period. During this period, patients undergo elbow test (1 drop of lavender oil will be dripped onto the inside of the patient's elbow, after 20 minutes, it will be evaluated whether an allergic reaction has developed). Lavender oil as aromatic oil will be administered to the patients in the aromatherapy group in the form of inhalation. Lavender oil inhalation (1 drop of 0.1 cc) It will be applied by inhalation with gauze on which 3-4 drops of lavender oil are poured. 30 minutes before surgery. Aromatherapy will be applied four times with an interval of 30 seconds on the 1st and 2nd days before and after the surgery.
Progressive Relaxation ExercisesOther
Patients participating in the study will be informed about relaxation exercises in the preoperative period. Progressive relaxation training will be applied to the patients for 30 minutes once a day, on the day before the operation and on the 1st and 2nd days after the operation.
Hand massageOther
Patients participating in the study will be informed about the application of massage therapy in the preoperative period. 10-15 minutes once in the preoperative period. And in the postoperative period, the 1st and 2nd days are 10-15 minutes. application will be carried out. Lavender oil (Lavandula Angustifolia) will be used in hand massage, sweet almond oil (Prunus Amygladus Sativa) will be used as essential oil.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | After randomization, the patients in the control group will be given pre- and post-operative nursing care without any intervention. |
| case group | Experimental | Patients in the case group after randomization will choose one or more of the music therapy, aromatherapy, progressive relaxation exercises and massage therapies according to their health care needs. Receives: Other: music therapy; Other: aromatherapy; Other: Progressive Relaxation Exercises; Other: Hand massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
After the pre-operative nursing practices, the Surgical Anxiety Scale will be filled by face-to-face interview method. State Anxiety Scale; consists of 20 items. The highest score that can be obtained from the scale is 80, and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person who completed the scale.
Measured: the day before surgery
Distribution of systolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
Measurement of systolic blood pressure of patients in the control and case groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline Systolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
sleep quality
The Richard-Campbell Sleep Scale will be used to assess the patient's nighttime sleep.The scale is a 6-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated with a visual analog scale technique and a chart between 0-100. Scores on the scale; A score of 0-25 indicates very bad sleep, and a score of 76-100 indicates very good sleep.
Measured: 2nd day after surgery
Change from pain on postoperative period
Visual analog Scale. It is a scale used to measure and monitor the severity of pain and is evaluated by the patient. The scale starts with the absence of pain (0) and ends with excruciating pain (10).
Measured: 10 minutes after music therapy/ aromatherapy/hand massage/progressive muscle relaxation exercises and Aftermusic therapy/ aromatherapy/hand massage/progressive muscle relaxation exercises 1st and 2nd day after surgery
Distribution of diastolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
Measurement of diastolic blood pressure of patients in the control and case groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline diastolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Distribution of heart rate of patients in case and control groups in intraoperative and postoperative period follow-ups
Measurement of heart rate of patients in the control and case groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Distribution of body temperature of patients in case and control groups in intraoperative and postoperative period follow-ups
Measurement of body temperature of patients in the control and case groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Distribution of respiratory rate of patients in case and control groups in intraoperative and postoperative period follow-ups
Measurement of respiratory rate of patients in the control and case groups in intraoperative and postoperative period follow-ups
Measured: Change from Baseline respiratory rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2022
- Study start15 Oct 2022
- Primary completion15 Oct 2023
- Study completion25 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ummuhan Yigid, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05446662
- Sponsor's protocol ID
- AIBU-KVC-UY-02
- Status last verified
- Jan 2025
- First submitted
- 20 Jun 2022
- Last updated
- 14 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Complementary Care Model on Patient Outcomes in Patients With Coronary Artery Bypass
- ClinicalTrials.gov ID
- NCT05446662
- Acronym / sponsor ID
- AIBU-KVC-UY-02
- Conditions
- Nursing Caries, Music Therapy, Aromatherapy, Preoperative Care, Postoperative Care, Complementary Therapies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 15 Oct 2022 (actual)
- Primary completion
- 15 Oct 2023 (actual)
- Study completion
- 25 Dec 2023 (actual)
- First posted
- 7 Jul 2022 (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.
The study will be carried out in Bolu Abant İzzet Baysal University İzzet Baysal Training and Research Hospital Cardiovascular Surgery Clinic between January 2022 and February 2023.
The population of the study will consist of patients who will undergo coronary artery bypass in a planned heart and meet the inclusion criteria.
The sample of the study will consist of patients who meet the inclusion criteria, volunteer to participate in the study, and whose written consent has been obtained.
To calculate the sample size of the study; NCSS Pass 11.0 program was used. According to the result calculated in this program, it was seen that a total of 60 people, 30 people in each group, should be reached for two groups and 99% power (α: 0.05).
With this study, it is aimed to increase the job satisfaction and quality of nurses as well as to increase the satisfaction of the patients in terms of nursing.
By presenting the Complementary Care Model to our country for the first time with this study; In this context, it was planned to determine the effects of music therapy, progressive muscle relaxation exercise, aromatherapy and massage on the outcomes (nausea, vomiting, sleep, anxiety, pain, complications and satisfaction) of coronary artery bypass graft patients.
Detailed description
Patients in the post-randomization application group will choose one or more of music therapy, aromatherapy, progressive relaxation exercises and massage therapies according to the predisposing factors, facilitating factors and health care needs in choosing these applications according to the complementary care model.
Before the application, data will be collected from the patients with an introductory form containing the demographic data of the patients, Visual Pain Scale (VAS), and State Anxiety Scale.
Vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature and respiratory rate) before and after the operation (10., 30. and 60. min), before and again on the 2nd and 3rd days after the operation. It will be measured and recorded after the application (10th, 30th, and 60th minutes).
After the preoperative practices, vital signs will be measured and the Surgery-Specific Anxiety Scale will be filled in by face-to-face interview method.
On the 1st and 2nd postoperative days, after each application, the VAS, the state anxiety scale, the visual comparison scale to evaluate the satisfaction level of the patients from the interventions after the 2nd postoperative day applications, and the Richard-Campell Sleep Scale to evaluate the night's sleep of the individual will be used.
Complications seen in the patient will be recorded on the patient follow-up form while the patients are discharged.
Routine pre- and post-operative nursing care will be given to the patients in the control group after randomization.
Data will be collected from the patients with an introductory form including their preoperative demographic data, Visual Pain Scale (VAS), and State Anxiety Scale.
Vital signs (systolic blood pressure, diastolic blood pressure, pulse, body temperature and respiratory rate) before and after the operation (10., 30. and 60. min), before and again on the 2nd and 3rd days after the operation. It will be measured and recorded after the application (10th, 30th, and 60th minutes).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –After randomization, the patients in the control group will be given pre- and post-operative nursing care without any intervention. |
| case group | Experimental | Other: music therapy, Other: aromatherapy, Other: Progressive Relaxation Exercises, Other: Hand massagePatients in the case group after randomization will choose one or more of the music therapy, aromatherapy, progressive relaxation exercises and massage therapies according to their health care needs. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who have undergone coronary bypass surgery with a beating heart-off pump,
- Those who are classified as I, II and III according to the system that the American Society of Anesthesiologists (ASA) classifies by evaluating patients according to their physical health status before surgery,
- Patients who do not have respiratory problems and are not allergic to plants
- Those without cognitive impairment,
- Those who can speak and communicate in Turkish and agree to participate in the study,
Key exclusion criteria (12 listed)
- Patients undergoing coronary bypass surgery using a cardiopulmonary bypass machine,
- Those who are classified as ASA IV, V and IV,
- Patients who could not be reached before surgery,
- People with asthma and allergies to plants
- Those with mental disorders (psychosis, dementia, delirium),
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 |
|---|---|---|
| music therapyPatients participating in the study will be informed about the application of music therapy in the preoperative period. The patients who will take part in the music group are given 30 minutes the day before the surgery, and 30 minutes a day on the 1st and 2nd days after the surgery. Music that is selected by the researcher and grouped as relaxing music, classical music, sufi music and Turkish folk music will be played. The patients will be listened to the music with headphones that cover the whole ear, and the music will be adjusted to make them feel comfortable. | Other | case group |
| aromatherapyPatients participating in the study will be informed about the application of aromatherapy in the preoperative period. During this period, patients undergo elbow test (1 drop of lavender oil will be dripped onto the inside of the patient's elbow, after 20 minutes, it will be evaluated whether an allergic reaction has developed). Lavender oil as aromatic oil will be administered to the patients in the aromatherapy group in the form of inhalation. Lavender oil inhalation (1 drop of 0.1 cc) It will be applied by inhalation with gauze on which 3-4 drops of lavender oil are poured. 30 minutes before surgery. Aromatherapy will be applied four times with an interval of 30 seconds on the 1st and 2nd days before and after the surgery. | Other | case group |
| Progressive Relaxation ExercisesPatients participating in the study will be informed about relaxation exercises in the preoperative period. Progressive relaxation training will be applied to the patients for 30 minutes once a day, on the day before the operation and on the 1st and 2nd days after the operation. | Other | case group |
| Hand massagePatients participating in the study will be informed about the application of massage therapy in the preoperative period. 10-15 minutes once in the preoperative period. And in the postoperative period, the 1st and 2nd days are 10-15 minutes. application will be carried out. Lavender oil (Lavandula Angustifolia) will be used in hand massage, sweet almond oil (Prunus Amygladus Sativa) will be used as essential oil. | Other | case group |
Primary outcome
Anxiety
Time frame: the day before surgery
After the pre-operative nursing practices, the Surgical Anxiety Scale will be filled by face-to-face interview method. State Anxiety Scale; consists of 20 items. The highest score that can be obtained from the scale is 80, and the lowest score is 20. The higher the calculated total anxiety score, the higher the anxiety level of the person who completed the scale.
Distribution of systolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline Systolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Measurement of systolic blood pressure of patients in the control and case groups in intraoperative and postoperative period follow-ups
sleep quality
Time frame: 2nd day after surgery
The Richard-Campbell Sleep Scale will be used to assess the patient's nighttime sleep.The scale is a 6-item scale that evaluates the depth of night sleep, the time to fall asleep, the frequency of awakening, the time to stay awake when awakened, the quality of sleep, and the noise level in the environment. Each item is evaluated with a visual analog scale technique and a chart between 0-100. Scores on the scale; A score of 0-25 indicates very bad sleep, and a score of 76-100 indicates very good sleep.
Change from pain on postoperative period
Time frame: 10 minutes after music therapy/ aromatherapy/hand massage/progressive muscle relaxation exercises and Aftermusic therapy/ aromatherapy/hand massage/progressive muscle relaxation exercises 1st and 2nd day after surgery
Visual analog Scale. It is a scale used to measure and monitor the severity of pain and is evaluated by the patient. The scale starts with the absence of pain (0) and ends with excruciating pain (10).
Distribution of diastolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline diastolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Measurement of diastolic blood pressure of patients in the control and case groups in intraoperative and postoperative period follow-ups
Distribution of heart rate of patients in case and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Measurement of heart rate of patients in the control and case groups in intraoperative and postoperative period follow-ups
Distribution of body temperature of patients in case and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Measurement of body temperature of patients in the control and case groups in intraoperative and postoperative period follow-ups
Distribution of respiratory rate of patients in case and control groups in intraoperative and postoperative period follow-ups
Time frame: Change from Baseline respiratory rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Measurement of respiratory rate of patients in the control and case groups in intraoperative and postoperative period follow-ups
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 14 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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. 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 music therapy, aromatherapy and Progressive Relaxation Exercises in people with Nursing Caries and Music Therapy, run by Abant Izzet Baysal 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 10 inclusion and 12 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 14 Jan 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?
Anxiety (time frame: the day before surgery). The study lists 8 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 14 Jan 2025.