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The Effect of nursing visit on preoperative anxiety and vital sings in the lumbar disk herniation surgery candidate patients

Protocol summary

Summary
(1)Objectives: To determine the effect of nursing visits on the level of preoperative anxiety and vital signs in patients undergoing lumbar disk herniation (2) Design: A random single-blind clinical trial (patients ) (3) conduction: The patients' medical records is evaluated a day before surgery and the eligible ones are selected. Anxiety and vital signs (systolic and diastolic blood pressure, pulse rate, respiratory rate and temperature of both groups) are recorded using the Spielberger Anxiety Questionnaire 19 to 20 hours before the surgery. Then, the nursing visit is conducted for the intervention group. Nursing visit includes a 30 to 50 minute-meeting of the patient which is performed by the nurse researcher and during which all the necessary information about lumbar disc herniation, causes of the disease, symptoms, treatments, preoperative preparation, the time and the way of transferring patients to the operating room, waiting time in the operating room, information about the surgery and anesthesia team, type of anesthesia, environment and equipment of the operating room, recovery room, measures taken in recovery, transference to the ward, post-operative care in the ward and the necessary verbal post-operative care after discharge are provided to the patient. Moreover, some explanations are given using audio-visual equipment such as tablet that contains photos and descriptions of the operating room environment, characteristics and the outcomes of surgery to the intervention group. (4) Participants and the major eligibility criteria: Patients scheduled for elective lumbar disc herniation referred to neurosurgical ward at Besat hospital in sanandaj city. Inclusion criteria: Patients undergoing lumbar disc herniation surgery, volunteers to participate in the study, elective surgery. Exclusion criteria: taking anxiety drugs which include: Alprazolam; Oxazepam; Chlordiazepoxide and Diazepam ( From 24 hours before the intervention to the time of remeasurement of anxiety ) and withdrawing of patients for any reason(5) Interventions: Nursing visit (6) Main consequence variables: anxiety and vital signs

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051627927N1
Registration date: 2016-09-09, 1395/06/19
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-09, 1395/06/19
Registrant information
Name
behrooz zarei
Name of organization / entity
Kurdistan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 87 3323 2115
Email address
behroozzarei62@muk.ac.ir
Recruitment status
Recruitment complete
Funding source
Kurdistan University of Medical Sciences
Expected recruitment start date
2016-06-20, 1395/03/31
Expected recruitment end date
2016-07-20, 1395/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of nursing visit on preoperative anxiety and vital sings in the lumbar disk herniation surgery candidate patients
Public title
The Effect of nursing visit on preoperative anxiety and vital signs
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients undergoing lumbar disc herniation surgery؛ volunteered to participate in the study؛ having elective surgery؛ surgery performed under general anesthesia or spinal anesthesia؛ No history of diseases such as high blood pressure؛ vascular disease؛ thyroid disease؛ rheumatoid arthritis؛ trauma to the lower back؛ fever؛ Lack of sedative-hypnotic drugs؛ no history of mental neurological disorders؛ lack of previous experience of surgery and the age between 18 to 65. Exclusion criteria: taking anxiety medications including Alprazolam؛ Oxazepam؛ Chlordiazepoxide and Diazepam ( from 24 hours before the intervention to the time of remeasurement of anxiety ) and withdrawal of patients for any reason
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Kurdistan University of Medical Sciences
Street address
Kurdistan University of Medical Sciences Pasdaran street, Sanandaj city Kurdistan province, Islamic Republic Of Iran
City
Sanandaj
Postal code
66135 - 756
Approval date
2016-08-13, 1395/05/23
Ethics committee reference number
IR.MUK.REC.1395/132

Health conditions studied

1

Description of health condition studied
lumbar Herniation Disk
ICD-10 code
55.1
ICD-10 code description
Lumbar and other intervertebral disc disorders with radiculopathy

Primary outcomes

1

Description
Anxiety
Timepoint
Before the intervention and the day after the intervention
Method of measurement
Spielberger Anxiety Questionnaire

2

Description
Vital signs
Timepoint
Before the operation and the day after the operation
Method of measurement
Sphygmomanometer, Stethoscope, Tympanic Thermometers

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 19 to 20 hours in the day prior to the surgery all the necessary information about lumbar disc herniation, causes of the disease, symptoms, treatments, preoperative preparation, the time and the way of transferring patients to the operating room, waiting time in the operating room, information about the surgery and anesthesia team, type of anesthesia, environment and equipments of the operating room, recovery room, measures taken in recovery, transference to the ward, post-operative care in the ward and the necessary verbal post-operative care after discharge are provided to the patients in a 30 to 50 minute visit. Moreover, some explanations are given using audio-visual equipments such as tablet that contains photos and descriptions of the operating room, the characteristics and the results of the surgery to the intervention group.
Category
Prevention

2

Description
There is no intervention and receive routine care alone.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Behrooz Zarei, Bachelor of Nursing
Street address
Department of Neurosurgery, Besat Hospital, Keshavarz street, Sanandaj city
City
sanandaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Kurdistan University of Medical Sciences
Full name of responsible person
Vice Chancellor for research
Street address
Vice Chancellor for research, Kurdistan University of Medical Science, Pasdaran street
City
Sanandaj
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 of Kurdistan 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
Kurdistan University of Medical Sciences
Full name of responsible person
Sina Valiee
Position
PhD, Assistant Professor
Other areas of specialty/work
Street address
Kurdistan University of Medical Sciences, School of Nursing and Midwifery
City
Sanandaj
Postal code
Phone
+98 87 3362 7228
Fax
+98 87 3366 0092
Email
SinaValiee@yahoo.com
Web page address
muk.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Behrooz Zarei
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Postal code
6615733173
Phone
+98 87 3362 7228
Fax
Email
Behroozzarei62@yahoo.com ; Behroozzarei62@muk.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kurdistan University of Medical Sciences
Full name of responsible person
Behrooz Zarei
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Kurdistan University of Medical Sciences, Pasdaran Street
City
Sanandaj
Postal code
Phone
+98 87 3323 2115
Fax
+98 33660092
Email
Behroozzarei62@yahoo.com ; Behroozzarei62@muk.ac.ir
Web page address
muk.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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