Protocol summary

Study aim
Determining the effect of education on the anxiety and self-efficacy of mothers of pediatric patients with surgery
Design
In this study, 60 mothers who were surgically and randomly selected to enter the study were divided into two intervention and control groups and each participant was assigned a code.
Settings and conduct
The researcher explained the research objectives to the mothers of surgical children referring to Taleghani Hospital in Gorgan and a pre-test questionnaire for both groups. Then she was given control in the routine training group during admission and admission and before surgery. However, in the test group, along with routine tests, trained and scheduled training is provided for 10 to 15 minutes in each section. The questionnaires will be completed again before entering the operating room.
Participants/Inclusion and exclusion criteria
Criteria for entering this study (mothers who have undergone surgery for their first child Lack of history of abortion, ability to speak and understand Persian, ability to take care of oneself and child, lack of physical and psychological illness, reading and writing literacy and the child undergoing general surgery) and mothers whose children have Physical and psychological problems such as mental retardation, cerebral palsy and congenital defects were excluded from this study.
Intervention groups
Educating cognitive strategies for eliminating neurotic stress, overcoming anxiety, reducing anxiety and making peace and improving the efficiency of mothers of surgical children since the patient's arrival to the clinic and establishing a child's surgery that fully educates the careers before, during and after The child's practice involves answering questions and removing ambiguities for mothers
Main outcome variables
The amount of stress; the ability of mothers to manage stress; child care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170512033932N1
Registration date: 2018-01-05, 1396/10/15
Registration timing: retrospective

Last update: 2018-01-05, 1396/10/15
Update count: 0
Registration date
2018-01-05, 1396/10/15
Registrant information
Name
Hosein Motahariniya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3222 4908
Email address
h_hojjati@aliabadiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The influence of education on anxiety and self-efficacy in mothers of children with surgery
Public title
The influence of education on anxiety and self-efficacy in mothers of children with surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers who used surgery for the first time in their child
Exclusion criteria:
A history of abortion Has a lack of speech and understanding of Persian language Inability to take care of yourself and the child Physical and mental illness Illiteracy, reading and writing, and having a child undergoing general surgery)Mothers whose children had physical and psychological problems (mental retardation, cerebral palsy, and congenital chronic defects)
Age
No age limit
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A simple randomization is done with sealed envelope tools in such a way that the envelopes are written in letters A and B, and the mothers are asked to select an envelope that the group A of the intervention group and the B group will be tested.
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 دانشگاه آزاد واحد چالوس
Street address
چالوس دانشگاه آزاد اسلامی واحد چالوس
City
Chalus
Province
Mazandaran
Postal code
46691-46611
Approval date
2017-08-23, 1396/06/01
Ethics committee reference number
IR.IAU.CHALUS.REC.1395.29

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.9
ICD-10 code description
F41.9

Primary outcomes

1

Description
Anxiety Scale from the Spielberger Anxiety Inventory
Timepoint
Before the intervention begins and after intervention(STAI)
Method of measurement
Based on total score of anxiety

2

Description
Self-efficacy scores from the Dumika questionnaire(PSAM)
Timepoint
Before the intervention begins and after intervention
Method of measurement
Based on total score of self-efficacy

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The training is done in eight sections based on the following: the type of disease and type of surgery that will be performed on the child. Familiarization and information about the facilities and personnel providing the facility to the patient and family. Pre-post and post-surgery photographs and examples of similar surgical procedures. Adoption and preparation of the child before surgery, including fasting and feeding, cleaning the surgical site, having routine tests, operating time, satisfaction The practice and the list of possible medications and child allergies, as well as the introduction of the head nurse and the department staff and rotia This section introduces the personnel and nurse of the department, interventions and nursing practices that are implemented during the hospitalization, how to admit to the surgery department and to carry out sterilization and serum therapy, and receive prescription drugs and antibiotics, the presentation of a pamphlet about the disease, coordinating with the operating room in the presence of the mother, answering the mother's questions about the time and procedure, attending the mother at the time of the child's admission in the operating room, familiarizing the mother with the surgery team and the anesthetist on the duration of the operation, encouraging the mother to express her feelings, Postoperative postoperative postoperative pain training, postoperative pain control, surgical warnings, diet, mobility, and f Child's excellence, timing of discharge and educational explanations, and answering mothers' questions. Presenting pamphlets on training, post-clearance training, follow-up and post-visit follow-up, and how to use medications
Category
Behavior

2

Description
Control group: In the control group, routine training is given during admission and admission and before surgery
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Hospital Taleghani , Gorgan Golestan
Full name of responsible person
Hosein Motaharinya
Street address
Janbazan Ave., Children's Hospital Taleghani
City
Gorgan
Province
Golestan
Postal code
49166 68197
Phone
+98 17 3223 4364
Email
hoseinmotahari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mr. Ruholah Samiei
Street address
Daneshgaha Ave.,Azad Univercity Aliabad
City
Aliabad
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1362@yahoo.com
Web page address
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Hosein Motahari Niya
Position
MSC Student of pediatric nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
no.28 Ave, Golshar Blvd,
City
Gorgan
Province
Golestan
Postal code
4916845118
Phone
+98 17 3212 8035
Email
hoseinmotahari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojati
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Azad University Ave , Azad University
City
Aliabad
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1392@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Hamid Hojjati
Position
Associate profesor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Azad Univercity Ave
City
Aliabad
Province
Golestan
Postal code
4941793451
Phone
+98 17 3422 4500
Email
h_hojjati1362@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
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