Clinical trial the effect of before-anesthesia education on crusher surgery through the skin
day anxiety, by spinal anesthesia compared with patients with routine care
The aim of this study is to evaluate the effect of before-anesthesia education on the level of anxiety in patients. The level of anxiety as the main variable was measured before education and on the morning of surgery using the Spielberger questionnaire. Education was provided to the intervention group according to Miller, 2011, the authoritative source book on anesthesia. The study population included all patients referred to Jahrom Peymanieh hospital for crusher surgery through the skin with spinal anesthesia. Patients with chronic pains and cancer, hearing or verbal impairment, mental and psychological problems, anti-anxiety drug users and health care workers were excluded from the study. The sample size was estimated to be 80 people. Patients were divided randomly, yet systematically, into control group (group I) and intervention group (group II) before surgery. In the first group anesthesia technician- without any intervention -filled out the questionnaire by the patient the day before surgery and on the morning of surgery. The second group received educations and consulting interventions by anesthesia technician in this way that the technician went to the patient's bedside the day before surgery and at first filled out the questionnaire by the patient, then he familiarized the patient with the type of anesthesia and surgical procedure and responded to all questions of the patient. Besides, he explained about the intended anesthetic technique and surgery complications. On the morning of surgery, the technician again met the patient in the operating room and filled out the questionnaire by the patient before surgery. All Patients had informed consent to participate in the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071814049N1
Registration date:2016-02-10, 1394/11/21
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-02-10, 1394/11/21
Registrant information
Name
Ali Abbasi Jahromi
Name of organization / entity
Jahrom University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 79 1334 1501
Email address
abbasija@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Jahrom University of Medical Sciences
Expected recruitment start date
2013-04-21, 1392/02/01
Expected recruitment end date
2014-04-21, 1393/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial the effect of before-anesthesia education on crusher surgery through the skin
day anxiety, by spinal anesthesia compared with patients with routine care
Public title
The effect of before-anesthesia education on surgery day anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: They include all patients who are to undergo crusher surgery through the skin in Peymanieh hospital affiliated with Jahrom University of Medical Sciences; spinal anesthesia can be performed for them; Informed consent to participate in this study. Exclusion criteria: education under primary school; chronic pains and cancer; Hearing or speech impairment; lack of mental and psychological health; chronic use of painkillers and narcotics; Unstable hemodynamic status; expressing disagreement for continuing the research; health care workers; anti-anxiety drug users; Incomplete filling of the questionnaire
Age
No age limit
Gender
Both
Phase
2
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
Ethic Committee of Jahrom University of Medical Sciences
Street address
School of medicine, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Approval date
2014-02-10, 1392/11/21
Ethics committee reference number
2766/پ/د
Health conditions studied
1
Description of health condition studied
The level of anxiety after educating patient
ICD-10 code
F48.8
ICD-10 code description
Other specified neurotic disorders
Primary outcomes
1
Description
Anxiety
Timepoint
The day before and the morning of surgery
Method of measurement
Spielberger questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
In the Control group: anesthesia technician- without any intervention -filled out the questionnaire by the patient the day before surgery and on the morning of surgery
Category
N/A
2
Description
Intervention group: Anesthesia technician went to the patient's bedside the day before surgery and filled out the questionnaire by the patient, before offering educations, then he familiarized the patient with the type of anesthesia and surgical procedure and responded to all questions of the patient. Besides, he explained about the intended anesthetic technique and surgery complications. On the morning of surgery, the technician again met the patient in the operating room and filled out the questionnaire by the patient before surgery.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Peymanieh Hospital
Full name of responsible person
Farzaneh Mehran
Street address
Nakhlestan Blvd, Jahrom
City
Jahrom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Jahrom University of Medical Sciences
Full name of responsible person
Solh Ju Kavos
Street address
Vice chancellor for research, Jahrom University of Medical Sciences, Motahhari Blvd, Jahrom Jahrom
City
Jahrom
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, Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
Farzaneh Mehran
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71 3743 8517
Fax
Email
MehranFarzaneh711@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Abbasi Jahromi Ali
Position
Faculty member
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
+98 71564742546
Fax
Email
AbbasiJa@jums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Farzaneh Mehran
Position
Anesthesia Undergraduate Student
Other areas of specialty/work
Street address
Nursing and Midwifery College, Motahhari Blvd, Jahrom
City
Jahrom
Postal code
Phone
00
Fax
Email
MehranFarzaneh711@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)