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The Effect of Complementary Care Model on Patient Outcomes

A

Abant Izzet Baysal University

Status

Completed

Conditions

Aromatherapy
Postoperative Care
Preoperative Care
Complementary Therapies
Music Therapy
Nursing Caries

Treatments

Other: music therapy
Other: Hand massage
Other: Progressive Relaxation Exercises
Other: aromatherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05446662
AIBU-KVC-UY-02

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

60 participants in 2 patient groups

control group
No Intervention group
Description:
After randomization, the patients in the control group will be given pre- and post-operative nursing care without any intervention.
case group
Experimental group
Description:
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.
Treatment:
Other: aromatherapy
Other: Progressive Relaxation Exercises
Other: Hand massage
Other: music therapy

Trial contacts and locations

1

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Central trial contact

ümmühan yiğit, master

Data sourced from clinicaltrials.gov

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