Aim was evaluation effect of psychological preparation on patient’s anxiety level before taking biopsy from breast in women referred to Ahvaz Golestan Hospital.
Design
This assessment is a clinical trial in Phase 3, patients who had a breast biopsy indications considered as the study group. In this study, 62 cases who meet the inclusion criteria will be selected. Patients will be divided into two groups, with 31 case in the intervention group and 31 cases in the control group nonrandomly, patients' anxiety status was evaluated and compared before and after the intervention.
Settings and conduct
This study was performed as a clinical trial in Ahvaz Golestan Hospital, also the study was not blind and not randomized.
Participants/Inclusion and exclusion criteria
Inclusion criteria included as conversational language persian, ability to communicate verbally, no previous history of breast biopsy, having conscious satisfaction, and exclusion criteria included as history of major psychiatric disorder and obvious physical problem
Intervention groups
For the intervention group, 2 to 3 hours before the biopsy, a psychiatric preparation was performed by a psychiatric assistant, also for the duration of the intervention for the case group, neutral materials (properties of fruits and vegetables) prepared in the form of pamphlets were given to the control group for study and no other intervention was performed.
Main outcome variables
Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200919048764N1
Registration date:2020-10-14, 1399/07/23
Registration timing:retrospective
Last update:2020-10-14, 1399/07/23
Update count:0
Registration date
2020-10-14, 1399/07/23
Registrant information
Name
Sajedeh Zarif
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3232 3051
Email address
sajedehzarif95@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-30, 1398/04/09
Expected recruitment end date
2020-04-28, 1399/02/09
Actual recruitment start date
2019-06-30, 1398/04/09
Actual recruitment end date
2020-04-28, 1399/02/09
Trial completion date
2020-04-28, 1399/02/09
Scientific title
The effect of psychological preparation on patient’s anxiety level before taking biopsy from breast in women referred to Ahvaz Golestan Hospital
Public title
The effect of psychological preparation on patient’s anxiety level before taking biopsy from breast
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Conversational language Persian
Ability to communicate verbally
No previous history of breast biopsy
Having conscious satisfaction
Exclusion criteria:
History of major psychiatric disorder
Obvious physical problem
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
62
Actual sample size reached:
62
Randomization (investigator's opinion)
Not 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 Ahvaz Jondishapur University of Medical Sciences
Street address
1579461357, olom pezeshki Blvd, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Approval date
2019-09-27, 1398/07/05
Ethics committee reference number
IR.AJUMS.REC.1398.476
Health conditions studied
1
Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition
Primary outcomes
1
Description
Timepoint
Method of measurement
2
Description
State anxiety
Timepoint
Before and after the intervention
Method of measurement
Spiel Berger overt and covert anxiety questionnaire
3
Description
Trait anxiety
Timepoint
Before and after the intervention
Method of measurement
Spiel Berger overt and covert anxiety questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, 2 to 3 hours before the biopsy, a psychiatric preparation was performed by a psychiatric assistant.
Category
Prevention
2
Description
Control group: For the duration of the intervention for the case group, neutral materials (properties of fruits and vegetables) prepared in the form of pamphlets were given to the control group for study and no other intervention was performed.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Golestan Hospital
Full name of responsible person
Masoumeh Nazari Nasab
Street address
6135733118, Golestan Hospital, Golestan Alley, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
ahvazgolestanhospital@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Korosh Zare
Street address
1579461357, olom pezeshki Blvd, Ahvaz, Khuzestan
City
Ahvaz
Province
Khouzestan
Postal code
1579461357
Phone
+98 61 3367 5430
Email
korosh1685@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazari Nasab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
6135733118, Golestan Hospital, Golestan Alley, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Masomenazari@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazari Nasab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
6135733118, Golestan Hospital, Golestan Alley, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Masomenazari@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Masoumeh Nazari Nasab
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Psychiatrics
Street address
6135733118, Golestan Hospital, Golestan Alley, Ahvaz, Khuzestan Province
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Email
Masomenazari@yahoo.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