Protocol summary

Summary
Patients in the intervention group (n = 37) and controls (n = 37) participated in this study and based on the type of work that is based on sampling random assignment and control groups based on the number of patient cases will be(allocation by a nurse of unit colonoscopy done who is not aware of the type of intervention) and given that waiting time per patient for colonoscopy 18-24 hours will be research in parallel with intervention samples; thus samples were then entered into the study, initially researcher first demographic questionnaire and through interviews with patients and records studies will be completed. The questionnaire contained a number of questions regarding demographic information and some questions about health and disease. Then if you have of entering the study the first researchers consent form to participate in the study, patients will be able to sign it. After you select the patient's get the satisfaction entering the study, patients entered the study and then by a second investigator who is unaware of the intervention and control groups for all subjects, including information on blood pressure, pulse and respiration per minute (before advice) and advice questionnaires of anxiety STAI If the interview is completed. Patients in the intervention group, a third researcher will consult with her bedside for 30 minutes. Individual counseling and face-to-face. The consultation, the consultation nursing and explain all the circumstances, including before, during and after colonoscopy is including training preparation before the procedure (diet, drugs, etc.), during a colonoscopy (a complete explanation about what will be done during the colonoscopy)patient raise awareness about the benefits and risks of giving the patient an opportunity to express feelings, questions, selecting appropriate ways to reduce anxiety and increase tolerance, procedures, and respond to questions posed by the patient. Patients in the control group, all of these steps can be done in consultation with the patient. The next day, the researcher prior to colonoscopy for people of all data including blood pressure, pulse and respiration and the minutes STAI state anxiety questionnaire is to be completed. Patient tolerance of colonoscopy and Satisfaction scale, the level of cooperation during colonoscopy, comfort level and pain level completion rates measure by which the researcher is unaware of the experimental and control groups will be compared in both groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013022011936N2
Registration date: 2013-07-05, 1392/04/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-07-05, 1392/04/14
Registrant information
Name
Mahmoud Amiri
Name of organization / entity
Shahed University
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 5182
Email address
mahmood.amiri18@yahoo.com
Recruitment status
Recruitment complete
Funding source
Student Research Center, Shahed University
Expected recruitment start date
2013-04-30, 1392/02/10
Expected recruitment end date
2014-06-15, 1393/03/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of nursing consultation program anxiety, tolerance and Satisfaction of patients undergoing colonoscopy Imam Khomeini Hospital in Tehran in 2013-2014
Public title
The effect of nursing consultation on anxiety, tolerance and satisfaction in patients undergoing colonoscopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 -75 years old; the ability to understand the Persian language; lacking a history previous colonoscopy; lack known history of psychological problems or anxiety disorders (According to the survey patient records ); lack of use sleep medications and sedatives on the day before colonoscopy; lack of severe pain due to the nature of the disease (for example cancer); lack of narcotic addiction or strong analgesics and absence of disease or a history of hypertension and antihypertensive drugs. Exclusion criteria: canceled on the day of colonoscopy to determine the cause of non-anxious patients and patient withdrew from participating the study.
Age
From 18 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 74
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
Shahed University
Street address
Tehran - Gulf Freeway - opposite the shrine of Imam Khomeini
City
Tehran
Postal code
3319118651
Approval date
2013-04-10, 1392/01/21
Ethics committee reference number
168149/41

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
Anxiety
Timepoint
Before intervention - a day after the intervention (before the procedure)
Method of measurement
Spielberger standard questionnaire

Secondary outcomes

1

Description
Tolerance
Timepoint
After Colonoscopy
Method of measurement
The Likert scale measure

2

Description
Satisfaction
Timepoint
After Colonoscopy
Method of measurement
Numerical scale (1 least satisfied - 10 most satisfied)

3

Description
Comfort
Timepoint
After Colonoscopy
Method of measurement
Comfort numerical scale (1 lowest Comfort, 10 maximum comfort level)

4

Description
Cooperation rates during colonoscopy
Timepoint
After Colonoscopy
Method of measurement
Numerical scale contribution (1 co lowest, 10 the highest level of cooperation)

5

Description
Pain
Timepoint
After Colonoscopy
Method of measurement
numeric pain scale (1 least amount of pain, 10 maximum pain)

Intervention groups

1

Description
Intervention group = received 30 minutes of nursing counseling program that includes training preparations in the days before colonoscopy -training what done colonoscopy - Basic skills training techniques to reduce anxiety
Category
Behavior

2

Description
Control group = received routine part of program
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital Complex
Full name of responsible person
Najm Zadeh Zahra
Street address
Tehran - Bagher Khan Street - Imam Khomeini Hospital Complex
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Kyasalary Zahra - Deputy Director of Research and Technology
Street address
Tehran - Gulf Freeway - Opposite the shrine of Imam Khomeini
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mahmoud Amiri
Position
Undergraduate Nursing students
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before the of Taleghani Crossroad- Alley Rhymzadh - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 4483 0485
Fax
+98 21 6641 8580
Email
mahmood.amiri18@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Majideh heravi karimovi
Position
PhD Nursing
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before Taleghani Crossroad- Rahimzadeh Alley - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 6641 8587
Fax
+98 21 6641 8580
Email
heravi@shahed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mahmoud Amiri
Position
Undergraduate Nursing students
Other areas of specialty/work
Street address
Tehran - Vali Asr Street - Before the of Taleghani Crossroad- Alley Rhymzadh - No. 6
City
Tehran
Postal code
1591715314
Phone
+98 21 4483 0485
Fax
+98 21 6641 8580
Email
mahmood.amiri18@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
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