Clinical trial NCT05446662: The Effect of Complementary Care Model on Patient Outcomes
Official title: The Effect of Complementary Care Model on Patient Outcomes in Patients With Coronary Artery Bypass
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nursing Caries
Music Therapy
Aromatherapy
Preoperative Care
Postoperative Care
Complementary Therapies
Lead sponsor: Abant Izzet Baysal University
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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,
* 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.

Exclusion Criteria:

* 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,
* 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.

Primary outcomes:
measure: Anxiety
timeFrame: the day before surgery
measure: Distribution of systolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline Systolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
measure: sleep quality
timeFrame: 2nd day after surgery
measure: Change from pain on postoperative period
timeFrame: 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
measure: Distribution of diastolic blood pressure of patients in case and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline diastolic Blood Pressure on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
measure: Distribution of heart rate of patients in case and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
measure: Distribution of body temperature of patients in case and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline heart rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
measure: Distribution of respiratory rate of patients in case and control groups in intraoperative and postoperative period follow-ups
timeFrame: Change from Baseline respiratory rate on intraoperative 10 minutes to 1 hours ; postoperative 10 minutes to 1 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bolu
country: Turkey
facility: Bolu Abant Izzet Baysal Training and Research Hospital
Study officials:
References: