Determining the effectiveness of Supportive counseling on the Fear and Psychological distress of Colposcopy in Women
Design
Clinical trial with control group, intervention, simple randomization, 40 Patients in the intervention group under counsultation, 40 Patients in the control group
Settings and conduct
In the women's clinic of Afzalipur Hospital, Kerman, women candidates for colposcopy are randomly divided into control and intervention groups. Both groups fill out the colposcopy fear questionnaire one week before colposcopy. The intervention group receives counseling. Then both groups fill out the fear questionnaire again before colposcopy. Both groups fill in the Psychological distress questionnaire immediately after colposcopy
Participants/Inclusion and exclusion criteria
Entry criteria: Having the age of 18 to 65 years, performing colposcopy for the first time, Being able to read and write, Not suffering from hearing or speaking disorders, Not having medical problems such as acute cardiovascular disease, Not suffering from neurological and mental disorders and Not using neurological and mental drugs.
Conditions of non-entry: suffering from any type of cancer, addiction and positive HPV test.
Intervention groups
The effect of supportive counseling on the Fear and Psychological distress of Colposcopy in the intervention group and Lack of advice in the control group and just filling in the questionnaire
Investigating the Effectiveness of Supportive Counseling on the Fear and Psychological Distress of Colposcopy in Women
Public title
Effect of Supportive Counseling on the Fear and Psychological Distress of Colposcopy
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Desire to Participate In the Study
Having the Age of 18 to 65 Years
Colposcopy for the First time
Literacy for Reading and Writing
Not Having a Hearing or Speaking disorder
Absence of Medical Problems such as Known Chronic systemic diseases،Heart disease,Acute Lung disease
Not Suffering from Nervous and Mental disorders
Not use of Neuroleptics
Exclusion criteria:
Having any type of cancer
Addicted people
People with a positive HPV test result
Age
From 18 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be available and allocating the samples to two intervention and Control groups will be done in a simple random manner on Colposcopy candidate women. The Randomization tool is a table of Random numbers. In order to assign people to two intervention and Control groups, block method will be used. In this method, Blocks of 4 are used. In each Block, two people are randomly placed in the intervention group and two people in the Control group
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Kerman University of Medical Sciences Et
Street address
Kerman University of Medical Sciences, Medical University Campus, Haft Bagh Highway, Kerman, Iran
City
kerman
Province
Kerman
Postal code
7616913555
Approval date
2023-12-23, 1402/10/02
Ethics committee reference number
IR.KMU.REC.1402.355
Health conditions studied
1
Description of health condition studied
Fear
ICD-10 code
F40.233
ICD-10 code description
Fear of injury
2
Description of health condition studied
psychological distress
ICD-10 code
F68.13
ICD-10 code description
Factitious disorder with combined psychological and physical signs and symptoms
Primary outcomes
1
Description
Fear score from the fear questionnaire
Timepoint
Before the intervention and after completion of counseling sessions
Method of measurement
questionnaire
2
Description
psychological distress score from Cervical Dysplasia Distress Questionnaire
Timepoint
Immediately after colposcopy
Method of measurement
Cervical Dysplasia Distress Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The people who are placed in the intervention group are placed under the group counseling of the first session a week before the appointment given for colposcopy. They will be asked to participate in the second session that will be held in the week of the colposcopy appointment. Therefore, the number of counseling sessions is 2, and each session lasts about 60-90 minutes.
Category
Behavior
2
Description
Control group:No intervention will be received and only completes the questionnaire
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Afzalipur Medical Education Center
Full name of responsible person
Effat Sotoodehnia
Street address
Imam Khomeini Highway, next to Shahid Bahonar University, Afzalipur Medical Education Center
City
Kerman
Province
Kerman
Postal code
7616913355
Phone
+98 34 3132 8000
Email
ef.sotoodehnia@gmail.com
Web page address
http://bankpezeshkan.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abedin Iranpour
Street address
Deputy of research and technology., Somayeh Crossroads
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3226 3719
Email
vcr@kmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
Kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Katayoun Alidousti
Position
Instructor of the midwifery faculty
Latest degree
Master
Other areas of specialty/work
Midwifery
Street address
Department of Midwifery., Razi Faculty of Nursing and Midwifery., Kerman University of Medical Sciences campus.,Haft Bagh Alavi
City
kerman
Province
Kerman
Postal code
7616913555
Phone
+98 34 3132 5219
Email
kalidousti@gmail.com
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
Undecided - It is not yet known if there will be 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