The effect of psycho-educational intervention on anxiety, embarrassment and concern in female patients referred to general male surgeon for colorectal examinations
The purpose of this study was to investigate the effect of psycho-educational intervention on anxiety, embarrassment and concern in female patients referred to a male general surgeon for colorectal examinations. Target population was female patients referred to a male general surgeon for colorectal examinations at the specialist infirmary of Imam Hassan Mojtaba Hospital.
Design
The study is a clinical trial and consists of two groups of control and intervention. Both groups are community based and pragmatic. Samples were chosen randomly and blind blinded in both groups. The sample size is 60 patients.
Settings and conduct
After project approval at the ethics and research registration committee on the Iranian clinical trial site, the researcher visited Imam Hassan Mojtaba Hospital in Darab city having a written introduction letter from Shiraz University of medical sciences and its security. After being introduced and getting permission from the authorities, he will precede the following steps:
Since, patient's appointment at Darab Hospital takes place on the morning of admission day and the patients are visited by a general surgeon on the same admission day, the researcher went to the hospital's specialist infirmary on the morning of admission and by introducing himself and presenting the introduction letter from the hospital, begins his work; he will introduce himself to patients who have appointment with the general surgeon and asks about their referral cause to the general surgeon, he identifies patients who have referred to a doctor for colorectal problems.
After sample selection, the nature of the research and its implementation are explained to patients and their optional participation aspect will be pointed, then a written consent letter is taken from patients knowingly. According to the surgeon visitation hour, samples of the test group will be matched to be present at the infirmary one hour earlier than the visitation start and the group samples are coordinated to be there 15 minutes earlier than the visitation start.
The blinding technique is like that those who give the questionnaires to patients and collect them, and the statistician who performs the data analysis do not know the groups, also a visitation day is assigned separately to the test group and another day is dedicated to the control group. Patients in the training group are asked to not talk about the information given in the training sessions with other people. Similarly, the necessary samples are collected.
Participants/Inclusion and exclusion criteria
The criteria for entering the study were as follows: Female patients referring to infirmary who require colorectal examinations and have following entry criteria will be included in the study:
1. Age range 18-60 years
2. Tendency to participate in research
3. Possibility to attend the sessions in person, in the training group patients
Exclusion criteria includes:
1. Having known mental illnesses such as chronic depression, psychosis and anxiety.
2. Participation in the same training sessions along with study three months before.
3. Failure to attend in more than two sessions.
4. Patients who will be trained but will not examined.
Intervention groups
160/5000
The intervention group consists of female patients who refer to the male general surgeon for colorectal examinations to the specialized clinic of the Imam Hassan Mojtaba Hospital in Darab.
Main outcome variables
Anexiety, embarrassment, concern about judgment
General information
Reason for update
Acronym
does not have
IRCT registration information
IRCT registration number:IRCT20170928036465N2
Registration date:2018-02-27, 1396/12/08
Registration timing:retrospective
Last update:2018-02-27, 1396/12/08
Update count:1
Registration date
2018-02-27, 1396/12/08
Registrant information
Name
zinat akade
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71364742548
Email address
zey_akede@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz university of medical sciences
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of psycho-educational intervention on anxiety, embarrassment and concern in female patients referred to general male surgeon for colorectal examinations
Public title
The effect of psycho-educational intervention on anxiety, embarrassment and concern of judgment in female patients referring to general male surgeon
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Age range of 18-60 years
Tendency to participate in research
Possibility to attend the sessions in person, in the training group patients
Exclusion criteria:
Age
From 18 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection: the method of selecting admission days of this surgeon for the intervention and control group will be randomly and by using random number table in block method. Visitation days for the mentioned surgeon will be done by randomized block design, and weekdays will be allocated to two groups through block method. First, the researcher constitutes different permutations of A (indicating the visitation date of intervention group) and B (indicating the visitation date of control group) which consist of 6 different modes: for example (1-AABB, 2-ABAB… 6-ABAB). Then to select specific days for control group and intervention group from the table, randomly moves his finger from a point in the random number table in a row or column direction. If a number between one and six is observed, its permutation will be noted. For example, if the number 6 appears, we note ABAB's permutation. In this way, the examination days will be allocated by the surgeon to intervention group (receiving training) and control group (without training).
The method of sample selection in this research is done randomly using a random number table; so the researcher selects 10 people randomly from the list of people who have taken appointment for colorectal examinations on the mentioned surgeon visitation day. The researcher trains those 10 people in two rounds and two groups of five before being visited. Selection method in the control group will be the same. The control group members without training will complete the questionnaire 15 minutes before the visit.
Blinding (investigator's opinion)
Double blinded
Blinding description
The blinding technique is like that those who give the questionnaires to patients and collect them, and the statistician who performs the data analysis do not know the groups, also a visitation day is assigned separately to the test group and another day is dedicated to the control group. Patients in the training group are asked to not talk about the information given in the training sessions with other people. Similarly, the necessary samples are collected.
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Avenue, opposite the Palestine Street, Central Building of Shiraz University of Medical Sciences
City
shiraz
Province
Fars
Postal code
71348-14336
Approval date
2017-11-21, 1396/08/30
Ethics committee reference number
IR.SUMS.REC.1396.166
Health conditions studied
1
Description of health condition studied
colorectal disease
ICD-10 code
k59 , c18
ICD-10 code description
Other functional intestinal Benign neoplasm of colon, rectum, anus and anal canalMalignant neoplasm of colon
Primary outcomes
1
Description
anexiety_ embarrassment_ concern about judgment
Timepoint
Before intervention and after intervention
Method of measurement
Measurement of Beck's Anxiety Scale and measurement of embarrassment and concern are judgments of the medical embarrassment questionnaire.
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is a face-to-face educational psychoanalysis program.Intervention group:Intervention method: Training groups will be 4 to 6 people and the training is done in a classroom formed at the infirmary, the training class includes:A: Educational pamphlet provided to the learner at the beginning of the classB: PowerPoint using a computer and monitorThe training time will be 60 minutes. At the beginning of the session and before the training, the researcher gives the questionnaires to patients and asks them to complete those questionnaires, then the training begins by the researcher. According to the educational pamphlet, the researcher first outlines the importance of conducting these examinations and notes the dangers of non-timely examinations and its non-adherence. Then explains the examination method with the help of images that represent how the examination will be performed. These images are available on Pamphlet and PowerPoint; Images and explanations will be based on how to make such examinations scientifically as well as the special procedure of the surgeon. Through these images and descriptions, we help the patients to learn how to prepare themselves for examinations. We explain to patients the cause of each question doctor asks and they will be asked to answer the questions correctly and tell the doctor real signs and symptoms in order to help the doctor identify the actual diagnosis. The duration of this training phase is estimated 30 minutes. After the training stage, the psychological preparation of patients begins. Fellow psychologist who is already coordinated with the research project, talks with patients and makes them mentally prepared to accept such examinations. The duration of this psychological counseling will be 30 minutes. During this psychological consultation, the group therapy will be used to solve the psychological aspect of this study. In such a way that in each session a group of 5 to 6 people will be settled under the college psychologist leadership and patients are asked to express all the negative emotions and thoughts, vague points, religious beliefs and their fears about these types of examinations and talk about the reason of these thoughts invasion and this kind of attitude toward this examination type. Then everyone in the group suggests a strategy and approach that considers as an appropriate solution to this problem and at the end, the best decision to solve the problem and accept these types of examinations will be provided by the group members under the management and leadership of fellow psychologist. In each session, the proposed solutions can be different with regard to the problems of the group members. Because decisions are made due to the members attitude and feelings in the same session. Also, there is a possibility that the proposed solution is different for each member of the same group. At the end of the class, the patient's questions are answered and they wait for visitation. Immediately after the patients in the test group were examined by a doctor, they are requested again.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Hasan Mojtaba Hospital in Darab
Full name of responsible person
zinat akade
Street address
Darab City Ayatollah Khamenei Boulevard, Imam Hasan Mojtaba Hospital
City
darab
Province
Fars
Postal code
7481766565
Phone
+98 71 5352 6991
Fax
+98 71 5352 6306
Email
ziakad20@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
jamshid eslami
Street address
Fars, Shiraz. Zand Avenue, next to the Red Crescent Building, Shiraz University of Medical Sciences. Floor 7
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
masoomeh rambod
Position
Doctor of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz
City
shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3677 4254
Fax
+98 71 3647 4252
Email
rambodm@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
masoomeh rambod
Position
Doctor of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz. Zand Street, Namazi Square. School of Nursing Midwifery, Shiraz
City
shiraz
Province
Fars
Postal code
13119–71936
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
rambodm@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz university of medical sciences
Full name of responsible person
masoome rambod
Position
Doctor of Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shiraz university of medical sciences
City
shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Fax
Email
rambodma@yahoo.com
Web page address
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