Objective: To determine The effect of holistic nurse’s intentional presence on depression, anxiety and stress in patients under coronary artery bypass surgery
This study is a controlled clinical trial which was conducted in 1395 in Mashhad.80 patients undergoing coronary artery bypass surgery were divided randomly into two Intervention and control groups. In the intervention group in 4 sessions of 30 to 45 minutes intentional presence was carried out at three physical, psychological and therapeutic levels at the time of hospital admission (1 session), ICU (1 session), surgical ward (2 sessions). Anxiety and depression in patients was measured before the intervention and after the treatment sessions by DASS21 tool. Routine procedures were performed in the control group and they were given educational pamphlets. Data was analyzed by SPSS software as well as chi-square and analysis of covariance
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112925288N1
Registration date:2016-10-13, 1395/07/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-13, 1395/07/22
Registrant information
Name
Zeinab Khajian galoogahi
Name of organization / entity
Medical science of mashhad university
Country
Iran (Islamic Republic of)
Phone
+98 51 3502 9218
Email address
khajianz1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2016-04-19, 1395/01/31
Expected recruitment end date
2016-05-09, 1395/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of holistic nurse's intentional presence on the depression, stress and anxiety of the patients undergoing coronary artery bypass graft
Public title
Effect of intentionality presence of Cardiac Artery Surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria of study
1. Willingness to participate in the study
2. Age between 38 and 75 years
3. Having at least the literacy of writing and reading
4. Having an elective surgery
5. The ability to communicate with researcher
6. Lack of psychological disorders
7. Non- use of antipsychotic drugs
8. Candidate for coronary artery bypasses graft (CABG)
9. Lack of drug addiction
Exclusion criteria of study:
1. Refusing from continued participation in the study and collaboration with researcher
2. Incidence of physical disorders during the study (drainage that requires for operating room again)
3. Death of subject of study
4. Postoperative cognitive dysfunction (delirium, lack of knowledge of time, place, and person)
5. Late recovery and prolonged hospitalization (recovery after 6 hours or hospitalization more than 2 days in intensive care unit)
6. Heart surgery for the second time
7. Postoperative drug addiction
Age
From 38 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Four ways PhD, School of Nursing and Midwifery, Mashhad Jarjani
City
Mashhad
Postal code
Approval date
2016-04-17, 1395/01/29
Ethics committee reference number
IR.MUMS.REC.1394.712
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
Anxiety
Timepoint
Before and then after intervention
Method of measurement
Dass21 scal and stressors
2
Description
Stress
Timepoint
Before and then after intervention
Method of measurement
Dass21 scal and stressors
3
Description
Depresion
Timepoint
Before and then after intervention
Method of measurement
Dass21 scal and stressors
Secondary outcomes
empty
Intervention groups
1
Description
In control group: In the beginning of patients’ admission to open heart surgery ward, subjects’ consent was obtained and their demographic information was obtained by a questionnaire examined their anxiety, stress, and depression and routine measures were taken for patients. In addition, educational pamphlets available in the ward along with educational pamphlets related to relation were provided for patents.
During patient discharge, questionnaire assessing the anxiety, stress, and depression DASS 21 was completed again. In the control group, relaxation techniques and training to patients were performed trough educational pamphlets (Appendix 10) without the presence of a nurse (researcher), but measuring vital signs were measured and recorded during the four stages similar to experimental group.
Category
Treatment - Other
2
Description
Experimental group: intervention begins from patient hospitalization time in the open-heart surgery time. After introducing himself to patients, completing the demographic form and conscious consent of patient, and completing assessing the anxiety, stress and depression of patient by DASSS 21, researcher implemented the presence process at three levels of 1. Physical presence, 2. Mental presence and 3. Therapeutic presence.
Accordingly, nurse will be able to select and use the best method for patients among the holistic methods based on unique investigation of each patient and determining the stressful resources, using strategies such as using and training relation or training the patient on unknowns, by relying on his specialized skill and knowledge, his nursing diagnoses (Table 3-1), and based on patient priority.
Specifically, presence of nurse depends on individual characteristics of nurse, individual characteristics of client, characteristics shared in the communicative space of nurse-client, an appropriate environment to do communicative task, and performance decisions of nurse. The first session of intended presence in the open-heart surgery ward and before surgery was implemented. The second session was implemented after patient recovery in the intensive care unit and third and fourth sessions were implemented in the heart surgery ward. During nurse-client interaction, there are points the probable dose of presence. Specifically, relying on his clinical skill and his previous experiences in the presence process, nurse interprets the latent delicate signs and objective needs of the patient, and he deliberates and makes decision in the special moment on the most appropriate presence dose by considering environmental factors. On average, presence dose is determined based on patient’s need in each shift and 30 to 45 minutes has been considered (Figure 3-10. If patient needed, number of therapeutic sessions and presence dose might increase. After therapeutic sessions of presence, on the patient discharge, patient complemented the questionnaire assessing the anxiety, stress, and depression DASS 21 again.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr.Shariati Hospital
Full name of responsible person
Nahid aghebati
Street address
Vakil Abad Blvd. end-street Imam Reza1 (AS)
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Mashhad University of Medical Sciences
Full name of responsible person
Dr.Tafaghodi
Street address
Daneshgah street; Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nahid Aghedati
Position
Nursing Ph.D
Other areas of specialty/work
Street address
West Ibn-e-Sina st.
City
Mashhad
Postal code
Phone
+98 51 3859 1511
Fax
Email
Aghebatin1@mums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mahhad University of Medical Sciences
Full name of responsible person
Nahid aghebati
Position
Nursing Ph.D
Other areas of specialty/work
Street address
West Ibn-e-Sina, School of Nursing and Midwifery
City
Mashhad
Postal code
9187113648
Phone
+98 51 3859 1511
Fax
Email
Aghebatin1@mums.ac.ir; Khajianz1@mums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zeinab Khajian Galoogahi
Position
MSc in Nursing, Critical Care
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Mahhad University of Medical Sciences Mashhad
City
Mashhad
Postal code
Phone
Fax
Email
Khajianz1@mums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)