Protocol summary

Summary
This study is designed for investigating effect of education on preoperative-anxiety level of hand surgery patients. It is a randomized clinical trial which will be performed on 104 patients. The inclusion criteria are being fifteen to forty five years old, proficiency in Persian, being able to read and write, having hand injury that undergoing operating for the first time and maximum post-admission time of 24 hours for the surgery. The exclusion criteria include having history of a known mental illness, consuming anti-anxiety and opioid drugs, having minor and severe hand injuries. At first, a number is assigned to each of the qualified patients and the numbers are randomly drawn out. Then, the patients are divided into two groups of intervention and control. Speilberg anxiety status form is given to the members of both groups. At the same time, the patients' BP and PR are recorded in both groups. Afterward, the intervention group is divided to groups with 2 to 4 members who were taught by a trained nurse. The provided training includes preoperative caring, way of admission to the operation room, anesthesia, post-surgery caring, physiotherapy and home care. The training is executed in one session for 30 to 60 min. The patients of both groups will be underwent the operation up to 24 hours after admission. Before the operation and in the operation room, Speilberg anxiety status form is given to the patients of both groups and their BP and PR are controlled and recorded again. The questionnaires and the results of BP and PR data of both groups will be compared with each other.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111238177N1
Registration date: 2013-08-31, 1392/06/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2013-08-31, 1392/06/09
Registrant information
Name
Mohammad Javad Fatemi
Name of organization / entity
Burn Research Center of Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 4275
Email address
mj-fatemi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-09-23, 1392/07/01
Expected recruitment end date
2013-12-22, 1392/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on preoperative - anxiety level of hand surgery patients in Hazrat Fatima Hospital
Public title
The effect of education on preoperative - anxiety level
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: 1- Fifteen to forty five years old patients 2- Proficiency in Persian and being able to read and write 3- Having hand injury that undergoing operating for the first time 4- Maximum post-admission time of 24 hours for the surgery Exclusion criteria: 1- History of known mental illness 2- Consumption of anti–anxiety and opioid drugs 3-Having minor injuries like finger tip injuries and sever injuries like hand amputation.
Age
From 15 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
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
Ethics committee of Tehran University of Medical Sciences
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Blvd, Tehran
City
Tehran
Postal code
1449614535
Approval date
2017-07-09, 1396/04/18
Ethics committee reference number
IR.IUMS.FMD.REC.1396.9311256005

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified

Primary outcomes

1

Description
Blood Pressure
Timepoint
Before education and before beginning of surgery in operation room
Method of measurement
Examination with phygmomanometer

2

Description
Pulse Rate
Timepoint
Before education and before beginning of surgery in operation room
Method of measurement
Examination by a nurse

Secondary outcomes

1

Description
Anxiety
Timepoint
Before education and before beginning of surgery in operation room
Method of measurement
Speilberg anxiety status form

Intervention groups

1

Description
Intervention group: The intervention group was divided to groups with 2 to 4 members who were taught by a trained nurse. The provided training included preoperative caring, way of admission to the operation room, anesthesia, post-surgery caring, physiotherapy and home care. The training was executed in one session for 30 to 60 min.
Category
Other

2

Description
Control group: Patients were not trained in the training class.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatima Hospital
Full name of responsible person
Jila Akbari Tochaee
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Tehran University of Medical
Full name of responsible person
Akbar Fotouhi
Street address
Central Department of Tehran University of Medical Sciences, Keshavarz Blvd, Tehran
City
Tehran
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 Tehran University of Medical
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
Hazrt Fatima Hospital
Full name of responsible person
Jila Akbari Tochaee
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
jila_ak@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Mohammad Javad Fatemi
Position
Associate Professor of Plastic and Reconstructive Surgery
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
mj-fatemi@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hazrat Fatima Hospital
Full name of responsible person
Jila Akbari Tochaee
Position
Bachelor of Nursing
Other areas of specialty/work
Street address
Hazrat Fatima Hospital, Seyed Jamaleddin Asadabadi Ave, Tehran
City
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Fax
+98 21 8872 3150
Email
jila_ak@yahoo.com
Web page address

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
Loading...