To determine the effect of pre-procedural psycho-education on pain perception and anxiety in women undergoing colposcopy
Design
a randomized, not blinded, parallel group, controlled trial
Settings and conduct
This study is a clinical trial conducted on women undergoing colposcopy in Imam Reza clinic.
Participants/Inclusion and exclusion criteria
The inclusion main criteria: women aged 20 to 50 years
anxiety score more than 30 with no history of psychological disorder and no history of previous colposcopy and no consumption of anti-anxiety drugs.The lack of inclusion main criteria: not completing the questionnaires in any phase of study
Intervention groups
The intervention group receives a 60 to 75 session of psychoeducation.The control group receives an informational pamphlet about colposcopy to study in waiting time.
Main outcome variables
pain & anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130721014086N12
Registration date:2019-09-03, 1398/06/12
Registration timing:registered_while_recruiting
Last update:2019-09-03, 1398/06/12
Update count:0
Registration date
2019-09-03, 1398/06/12
Registrant information
Name
Mohammad Aghajani
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 2001
Email address
aghajani_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-21, 1398/04/30
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of pre-procedural psycho-education on pain perception and anxiety in women undergoing colposcopy
Public title
The efffect of pre-procedural psycho-education on pain perception and anxiety in women undergoing colposcopy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
women aged 20 to 50 years
anxiety score more than 30
Exclusion criteria:
history of psychological disorder
history of previous colposcopy
consumption of anti-anxiety drugs
Age
From 20 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
patients are divided into two groups consisting the case and the control group by permuted block randomization using 10 blocks of 6. randomization is done by using computer and random digit table
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
Kashan University of Medical Siences
Street address
vise chancellor of research andtechnology, kashan university of medical sciences, 5th km of Ravand Ghotb Blvd, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Approval date
2019-07-17, 1398/04/26
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1398.047
Health conditions studied
1
Description of health condition studied
anxiety
ICD-10 code
F41.9
ICD-10 code description
Anxiety disorder, unspecified
2
Description of health condition studied
pain
ICD-10 code
R10.2
ICD-10 code description
Pelvic and perineal pain
Primary outcomes
1
Description
anxiety
Timepoint
before intervention and immediately after intervention
Method of measurement
The Stat- Trait Anxiety Inventoty
2
Description
pain
Timepoint
after colposcopy
Method of measurement
Visual Analog Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group received a psychoeducational session before undergoing the colposcopy. Psychoeducation consisted of a 60 to 70 face to face session consist of 2 to 5 patients where patients are introduced to each other and a trained researcher provides information about the aims of the group as well as, active listening to patients feelings and problems, educating patients about Papsmear and necessity of doing colposcopy and preventing cervical cancer, introducing medical staff and the procedure of colposcopy, emotional support, through empathy,congruence, and unconditional positive acceptance. Also the researcher provides psychological anxiety reducing techniques such as trying to improve patients tendency to accept the importance of the procedure, Training deep breath, imagination, muscle relaxation and pain reducing techniques.
Category
Behavior
2
Description
Control group: The control group received an informational pamphlet containing information about colposcopy
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza clininc, Beheshti St, Kashan
Full name of responsible person
Mahshid Jamalzade
Street address
Kashan University of medicine, Km 3 Ravand Road, Kashan
City
Kashan
Province
Isfehan
Postal code
87155988141
Phone
+98 31 5554 0021
Email
m74jamalzade@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafshe
Street address
Ravand
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Email
aghajani1362@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Muhammad Aghajani
Position
lectuerer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Ghotbe Ravandi, Kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 31 5554 0021
Fax
+98 31 5554 3366
Email
aghajani1362@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad Aghajani
Position
Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Pole Ravand, kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 5551 0021
Email
aghajani1362@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mohammad aghajani
Position
lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Km 3 Pole Ravand, kashan
City
Kashan
Province
Isfehan
Postal code
8715988141
Phone
+98 36 5551 0021
Fax
Email
aghajani_m@kaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available