Determining the preoperative awareness of anxiety in patients undergoing breast cancer surgery
Design
Clinical trial has two groups of control and intervention with parallel groups that have been randomized without blindness. The clinical trial has two groups of control and intervention with parallel groups that have been randomized without blindness.
Settings and conduct
The research environment is the Department of Women's Surgery and Institute for Disease Control, affiliated to Imam Khomeini Hospital, affiliated to Tehran University of Medical Sciences. Sampling in this research is done randomly and using quadrilateral blocks method.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Age 18 before menopause
Definitive diagnosis of breast cancer
The first surgical experience
Ability to read and write
Fluency in Farsi
Lack of family relationship with other participants in the research
Not having a cancer patient in the family
Not to be a medical staff
Lack of speech and hearing problems
Lack of dementia and cognitive impairment
The hospital stay is at least 24 hours
Not receiving drugs that can reduce or increase cortisol (such as corticosteroids, anticonvulsants, insulin)
One-way mastectomy candidate
Exit criteria:
Any severe changes and deterioration in the condition during the study
Any type of offensive treatment during the study
Any patient dissatisfaction during the implementation of the project
Intervention groups
The intervention and control group includes all clients aged 18 before menopause with a definitive diagnosis of breast cancer who have been admitted for at least 24 hours for unilateral mastectomy in the Cancer Institute's Cancer Institute
Main outcome variables
Salivary cortisol; anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181130041803N1
Registration date:2018-12-03, 1397/09/12
Registration timing:prospective
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
sara pakzadkaramad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7751 4933
Email address
sarah.pakzad.karamad.1991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-05, 1397/10/15
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of provision of information on anxiety before surgery in patients with breast cancer
Public title
The effect of provision of information on anxiety before surgery in patients with breast cancer
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The first surgical experience
Ability to read and write
Mastering in Persian language
There is no familial relationship with other participants in the research
There is no cancer in the family
Not to be a medical staff
Do not have a speech and hearing problem
Dementia and cognitive impairment
At least 24 hours in hospital
No medications that reduce or increase cortisol (such as corticosteroids, anticonvulsants, insulin)
One-way mastectomy candidate is a one-way mastectomy candidate
Definitive diagnosis of breast cancer
Exclusion criteria:
Any severe changes and deterioration in the condition during the study
Any type of offensive treatment during the study
Any patient dissatisfaction during the implementation of the project
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
More than 1 sample in each individual
Number of samples in each individual:
2
Saliva Sample To Check Salvia Cortisol
Randomization (investigator's opinion)
Randomized
Randomization description
Random Rearranged Block Designs Two Blind Quadruple Treatments:
Thus, the letter A for the intervention group and the letter B for the control group are considered. Then we write all the reciprocal combinations of the letters A, A, B and B, which are 6 different combinations, on the 6 cards, thus:
1. AABB
2. ABBA
3. ABAB
4. BAAB
5. BABA
6. BBAA
Then we select random numbers from digits 1 through 6 (by random number table or patient number one we want to randomly select a card). For example, if the number 2 is selected, the concept is that the first person in the intervention group was the next two in the control group and the fourth in the intervention group, and we continue to do this until the sample size reaches the quotient
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
کمیته اخلاق در پژوهش های زیست پزشکی
Street address
Tehran University of Medical Sciences.,Dr Mirkhani St. (Eastern Nusrat).,Tohid Square
City
تهران
Province
Tehran
Postal code
1419733171
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.TUMS.FNM.REC.1397.144
Health conditions studied
1
Description of health condition studied
Breast Cancer
ICD-10 code
ICD-10 code description
2
Description of health condition studied
Salivary cortisol
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Anxiety before surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Measuring the salivary cortisol
Timepoint
۶۷/۵۰۰۰Measure salivary cortisol before the intervention and the morning after the intervention
Method of measurement
Salivary Cortisol Measurement by ELISA Method by Measuring Saline Cortisol Kit
2
Description
Psychological anxiety score of patients with mastectomy candidates in DASS-21 questionnaire
Timepoint
Measurement of anxiety at the beginning of the study and the day after the interventionپرسشنامه
Method of measurement
Anxiety and Stress Questionnaire DASS-21
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients in the intervention group included all patients aged 18 years before menopause with definite diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the Department of Women's Surgery or Immunomotor Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. To the intervention group, in order to inform and inform before surgery, the written information includes information on patient health and surgical care and post-operative care, and oral explanations and responses to the questions of the patients are also done by the researcher. The saliva sample is collected again and the DASS-21 questionnaire is completed
Category
N/A
2
Description
Control group: Patients in the control group included all patients aged 18 before menopause with a diagnosis of breast cancer who were admitted for unilateral mastectomy for at least 24 hours in the gynecologic department of Imam Khomeini Cancer Institute who were randomly assigned to blocks Four have been selected in this group after collecting information about demographic and salivary samples from 3 to 5 cc before being informed. Saliva samples are taken to measure cortisol concentrations between 8:30 and 7:30 in the morning. Brushing and eating and drinking is not allowed for the client for half an hour before taking saliva. Samples are immediately sent to the laboratory and freeze at -20 ° F. Then it is centrifuged at 2500 rpm and ultimately measured by ELISA and using the kit of salivary cortisol. Then, the DASS-21 anxiety inventory questionnaire will be completed by patients with the presence of the researcher. The control group only receives routine pre-surgical training information. Then again, collect the saliva and complete the DASS-21 questionnaire.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
مجتمع بیمارستانی امام خمینی
Full name of responsible person
sara pakzad karamad
Street address
Imam Khomeini Hospital Complex.,Dr. Gharib Street.,End of Keshavar Blvd
City
tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1615
Email
Imamhospital@tums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojdeh Navid Hamidi
Street address
School of Nursing and Midwifery,Tehran University of Medical Sciences.,Nosrat st., Tohid sq
City
tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Fax
+98 21 6105 4170
Email
nursing_intl@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
sara pakzad karamad
Position
masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 7751 4933
Email
sarah.pakzad.karamad.1991@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sara pakzad karamad
Position
masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
tehran
Province
Tehran
Postal code
141973317
Phone
+98 21 6691 4368
Fax
+98 21 6105 4170
Email
sarah.pakzad.karamad.1991@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
sara pakzad karamad
Position
masters student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing Midwifery ,Tehran University of Medical Sciences Nosrat st. Tohid sq
City
tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6691 4368
Fax
+98 21 6105 4170
Email
sarah.pakzad.karamad.1991@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The total potential data can be shared after unidentifiable individuals
When the data will become available and for how long
Get started 6 months after printing results
To whom data/document is available
Researchers in academic and scientific institutions
Under which criteria data/document could be used
Post-print results will be announced
From where data/document is obtainable
Library of the Faculty of Nursing and Midwifery, Tehran University of Medical Sciences
What processes are involved for a request to access data/document