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The effect of psycho-educational intervention on anxiety, embarrassment and concern in female patients referred to general male surgeon for colorectal examinations

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History
# Registration date Revision Id
2 2018-11-30, 1397/09/09 70844
1 2018-02-27, 1396/12/08 38513
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  • Protocol summary

    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.
    The comparison of psycho-educational intervention with placebo on anxiety, embarrassment and concern in female patients referred to a male general surgeon for colorectal examinations
    هدف از انجام مطالعه: هدف این مطالعه بررسی تاثیر مداخله روانی - آموزشی بر اضطراب، خجالت و نگرانی در بیماران زن مراجعه‌کننده به جراح عمومی مرد برای معاینات کولورکتال است. جمعیت مورد مطالعه بیماران زن مراجعه کننده به جراح عمومی مرد جهت معاینات کولورکتال در درمانگاه تخصصی بیمارستان امام حسن مجتبی علیه السلام هستند.
    مقایسه مداخله روانی-آموزشی با دارونما بر اضطراب، خجالت نگرانی بیماران زن مراجعه‌کننده به جراح عمومی مرد برای معاینات کولورکتال
    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.
    A clinical trial with control group, parallel group randomized trial and single blind
    مطالعه از نوع کارآزمایی بالینی است و شامل دو گروه کنترل و مداخله است. هر دو گروه مطالعه مبتنی بر جامعه و عمل گرا هستند. نمونه ها به صورت تصادفی ساده انتخاب شده اند و کورسازی در هر دو گروه دو سویه کور است. حجم نمونه ۶۰ بیمار است.
    کارآزمایی بالینی دارای گروه کنترل، با گروه موازی تصادفی شده و یک سو کور
    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.
    The setting of this study would be Imam Hassan Mojtaba Hospital in Darab city. In this study, a person who collects the outcomes of the study as well as a statistician and physician will be blind until the end of the study and completion of the data analysis and reporting.
    پژوهشگر پس از تصویب طرح در کمیته اخلاق و ثبت پژوهش در سایت کارآزمایی بالینی ایران، با در دست داشتن معرفی نامه کتبی از دانشگاه و حراست علوم پزشکی شیراز به بیمارستان امام حسن مجتبی (ع) شهرستان داراب مراجعه نموده و پس از معرفی و کسب اجازه از مسئولین مراحل زیر را طی خواهد کرد: به علت اینکه در بیمارستان داراب نوبت دهی بیماران در صبح روز پذیرش انجام می شود و ویزیت بیمار توسط جراح عمومی در عصر همان روز پذیرش انجام می شود، پژوهشگر صبح روز پذیرش به درمانگاه تخصصی بیمارستان مراجعه کرده و با معرفی خود و ارائه معرفی نامه از طرف بیمارستان کار خود را آغاز می کند، به بیمارانی که آن¬روز نوبت ویزیت شدن توسط جراح عمومی را می¬گیرند خود را معرفی کرده و جویای علت مراجعه بیمار به جراح عمومی می شود و بیمارانی که جهت مشکلات کولورکتال به پزشک مراجعه کرده اند را شناسایی می کند. پس از انتخاب نمونه ماهیت پژوهش و نحوه اجرای پژوهش برای بیماران توضیح داده می شود، جنبه اختیاری بودن شرکت آنان در این پژوهش خاطر نشان می گردد و رضایتنامه کتبی آگاهانه از بیماران گرفته می شود. با اطلاع از ساعت شروع ویزیت توسط جراح با نمونه¬های گروه آزمون هماهنگ می شود که یک ساعت زودتر از ساعت شروع ویزیت در درمانگاه حضور داشته باشند و با نمونه های گروه کنترل هماهنگ می شود که 15 دقیقه زودتر از ساعت شروع ویزیت در درمانگاه حضور داشته باشند. نحوه کورسازی به این صورت است که کسانی که پرسشنامه¬ها را در اختیار بیماران قرار داده و آنها را جمع¬آوری می¬کنند و متخصص آماری که تحلیل داده¬ها را انجام می¬دهد از گروهها اطلاع ندارد و اینکه یک روز از ویزیت به صورت جداگانه به گروه آزمون اختصاص داده می¬شود، یک روز دیگر به گروه کنترل اختصاص داده می¬شود، از بیماران در گروه آموزش خواسته می¬شود در مورد اطلاعات داده شده در جلسات آموزشی با افراد دیگر صحبت نکنند. به همین ترتیب تا تعداد نمونه¬های لازم جمع¬آوری شوند.
    محل انجام مطالعه بیمارستان امام حسن مجتبی (ع) شهرستان داراب است. در این مطلعه فردی که پیامدهای مطالعه را جمع آوری می کند و همچنین متخصص آمار و به علاوه پزشک متصص نسبت به گروه ها تا پایان مطالعه و اتمام تحلیل داده ها و گزارش آنها کور خواهد بود.
    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.
    The inclusion criteria were female patients with age range 18-60 years, and possibility to attend the sessions in person, in the training group patients. Having known mental illnesses such as chronic depression, psychosis and anxiety. The subjects who participate in the same training sessions along or 3 months ago, not attend in more than two sessions, and patients who will be trained but will not examined would be excluded. 1.
    معيارهاي ورود به مطالعه به شرح ذيل بود: بیماران زن مراجعه کننده به درمانگاه که نیاز به معاینات کولورکتال دارند و معیارهای ورود زیر را دارند در مطالعه وارد خواهند شد: 1- سن در محدوده 60-18 سال 1- تمایل به شرکت در پژوهش 2- امکان شرکت در جلسات به‌صورت حضوری، در بیماران گروه آموزش معيارهاي خروج از مطالعه شامل: 1- ابتلا به بیماری‌های روانی شناخته شده افسردگی مزمن، اضطراب و سایکوز و. . . . 2- شرکت در کلاس‌های آموزشی مشابه همزمان با مطالعه و سه ماه قبل از آن 3_ عدم شرکت در بیش از دو جلسه آموزشی 4_ بیمارانی که آموزش خواهند دید ولی معاینه نخواهند شد.
    معيارهاي ورود شامل زنان با سن در محدوده 60-18 سال و امکان شرکت در جلسات به‌صورت حضوری در بیماران گروه آموزش است. افراد مبتلا به بیماری‌های روانی شناخته شده افسردگی مزمن، اضطراب و سایکوز و. . . .، شرکت در کلاس‌های آموزشی مشابه همزمان با مطالعه و سه ماه قبل از آن، عدم شرکت در بیش از دو جلسه آموزشی و بیمارانی که آموزش خواهند دید ولی معاینه نخواهند شد؛ از مطالعه حذف خواهند شد.
    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.
    Firstly, the researcher find the patients who refer to general surgeon for colorectal problems. The subjects in intervention group would be asked to be present in clinic one hour before physician visit. The subjects would receive 30 min education and 30 min psychological intervention. However, the subjects in control group would refer 15 min before visit and they would not receive intervention and receive the same program that is provided to the intervention group.
    گروه مداخله شامل بیماران زن است که جهت معاینات کولورکتال به جراح عمومی مرد به درمانگاه تخصصی بیمارستان امام حسن مجتبی علیه السلام شهرستان داراب مراجعه می کنند.
    پژوهشگر ابتدا بیمارانی که جهت مشکلات کولورکتال به جراح عمومی رمراجعه می کنند را شناسایی می کند. از افراد گروه آزمون خواسته می شود یک ساعت زودتر از ساعت شروع ویزیت در درمانگاه حضور داشته باشند. بیماران 30 دقیقه آموزش و 30 دقیقه مداخله روانشناسی را دریافت می کنند. در حالی که بیماران گروه کنترل 15 دقیقه قبل از ویزیت مراجعه کرده و هیچ مداخله ای را دریافت نمی کنند و همان برنامه معمول درمانگاه که به گروه مداخله ارائه می شود را دریافت می کنند.
    Anexiety, embarrassment, concern about judgment
    Anxiety, embarrassment, concern about judgment
    اضطراب، خجالت، نگرانی در مورد قضاوت شدن
    اضطراب؛ خجالت؛ نگرانی در مورد قضاوت شدن

  • General information

    Double blinded
    Single blinded
    2017-11-22, 1396/09/01
    2018-02-28, 1396/12/09
    2018-01-20, 1396/10/30
    2018-04-29, 1397/02/09

Protocol summary

Study aim
The comparison of psycho-educational intervention with placebo on anxiety, embarrassment and concern in female patients referred to a male general surgeon for colorectal examinations
Design
A clinical trial with control group, parallel group randomized trial and single blind
Settings and conduct
The setting of this study would be Imam Hassan Mojtaba Hospital in Darab city. In this study, a person who collects the outcomes of the study as well as a statistician and physician will be blind until the end of the study and completion of the data analysis and reporting.
Participants/Inclusion and exclusion criteria
The inclusion criteria were female patients with age range 18-60 years, and possibility to attend the sessions in person, in the training group patients. Having known mental illnesses such as chronic depression, psychosis and anxiety. The subjects who participate in the same training sessions along or 3 months ago, not attend in more than two sessions, and patients who will be trained but will not examined would be excluded. 1.
Intervention groups
Firstly, the researcher find the patients who refer to general surgeon for colorectal problems. The subjects in intervention group would be asked to be present in clinic one hour before physician visit. The subjects would receive 30 min education and 30 min psychological intervention. However, the subjects in control group would refer 15 min before visit and they would not receive intervention and receive the same program that is provided to the intervention group.
Main outcome variables
Anxiety, 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: prospective

Last update: 2018-12-15, 1397/09/24
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
2018-02-28, 1396/12/09
Expected recruitment end date
2018-04-29, 1397/02/09
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)
Single 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
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