This study assesses how psychological education reduces mothers' preoperative anxiety and boosts self-efficacy, guiding development of hospital preoperative protocols.
Design
This RCT employs a pretest-posttest design allocating 62 mothers of pediatric surgery patients (31/group) via web-based randomization to intervention or control arms at Imam Ali (AS) Hospital, Karaj, following eligibility screening.
Settings and conduct
Study Population:
Mothers of children under 7 years undergoing urologic surgery at Imam Ali (AS) Hospital, Karaj (2025)
Intervention Group:
Session 1: Surgical education + maternal anxiety analysis (DTR) + cognitive restructuring
Session 2: Decatastrophizing techniques + progressive muscle relaxation + stress coping strategies
Session 3: Post-operative challenge visualization + child care techniques
Control Group:
Standard surgical education
Participants/Inclusion and exclusion criteria
Inclusion criteria
Mothers of children <7 years old scheduled for pediatric urologic surgery; No comorbid psychiatric disorders in either mother or child; Maternal score >43 on the Spielberger State Anxiety Inventory; Child's first surgical procedure; Mother's literacy (ability to read/write);Willingness to participate (signed consent form)
Conditions of exclusion
Mothers of children undergoing emergency or non-urologic surgeries; Diagnosis of any psychiatric disorder in either mother or child; Maternal Spielberger score <43; Children with previous surgical experience; Illiterate mothers or those unable to complete questionnaires; Refusal to consent or incomplete baseline data
Intervention groups
Experimental Group:
Three virtual psychological education sessions for mothers
Control Group:
One educational session providing surgery-related information for mothers
Main outcome variables
Mothers' anxiety; Mothers' self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250222064815N1
Registration date:2025-04-06, 1404/01/17
Registration timing:registered_while_recruiting
Last update:2025-04-06, 1404/01/17
Update count:0
Registration date
2025-04-06, 1404/01/17
Registrant information
Name
Maryam Hafez
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 5919
Email address
maryamhafez78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-24, 1403/12/06
Expected recruitment end date
2025-05-20, 1404/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of psychological education on mothers' self-efficacy and their anxiety before their children's surgery
Public title
Investigating the effect of psycho education on mothers' self-efficacy and anxiety before their children's surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Mothers of children under 7 years of age on the verge of pediatric urological surgery
Absence of comorbid psychiatric disorders in children
Absence of major psychiatric disorders such as mood and psychotic disorders in mothers
Mothers with a Spielberger State Anxiety Scale score above 43
First-time surgery in children
Mothers having the ability to read and write
Willingness to participate in the research and signing the consent form
Exclusion criteria:
Mothers of children undergoing emergency or non-urologic surgeries
Diagnosis of any psychiatric disorder in either mother or child
Maternal Spielberger State Anxiety score <43
Children with previous surgical experience
Illiterate mothers or those unable to complete questionnaires
Refusal to participate or incomplete baseline data
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomized controlled trial, we assign 62 participants to intervention or control groups using computerized randomization. Eligible mothers of children referred to Imam Ali (AS) Hospital’s pediatric surgery clinic are enrolled after meeting inclusion criteria. Allocation is based on the order of enrollment.
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 Isfahan University of Medical Sciences
Street address
No. 33, Zanbaq 20, Zanbaq Blvd., Azimieh, Karaj Town
City
Karaj
Province
Alborz
Postal code
3155888856
Approval date
2024-12-14, 1403/09/24
Ethics committee reference number
IR.MUI.MED.REC.1403.394
Health conditions studied
1
Description of health condition studied
Anxiety and self-efficacy of mothers before their children's surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Anxiety score on the Spielberger Anxiety Inventory
Timepoint
Before the start of psychoeducation sessions and after the sessions are completed until before surgery
Method of measurement
Spielberger State-Trait Anxiety Inventory
2
Description
Dumka Parenting Self-Efficacy Scale Score
Timepoint
Before the start of psychoeducation sessions and after the sessions are completed until before surgery
Method of measurement
Domka Parenting Self-Efficacy Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group:Three preoperative psychological education sessions for mothers:Session 1:Surgical education (admission process, procedure duration, recovery, hospitalization) Anxiety analysis using DTR technique Cognitive restructuring (information provision, probability evaluation, problem-solving) Session 2 :Surgery education review (if needed)Cognitive restructuring using de-catastrophizing Stress management:Progressive muscle relaxation training (with audio guide)Coping strategies for stressful situations. Session 3: Guided imagery for post-operative concerns Child care techniques:Distraction methods Pleasant stimulus provision.
Category
Treatment - Other
2
Description
The control group will participate in a single preoperative education session providing comprehensive information about the surgical process, including hospitalization procedures, expected duration of surgery and recovery, postoperative care requirements, and necessary hospitalization items. The session also includes a therapist-facilitated discussion where mothers can share concerns and questions about their child's surgery. This discussion is guided by the therapist but does not include any specialized psychological education or intervention, while providing a platform for participants to exchange experiences.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali (AS) Hospital
Full name of responsible person
Maryam Hafez
Street address
No. 33, Zanbaq 20, Zanbaq Blvd, Azimieh.
City
Karaj
Province
Alborz
Postal code
3155888586
Phone
+98 26 3253 5919
Email
maryamhafez78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services, Building No. 4, Vice President for Research and Technology
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
askari@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zargar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Medicine
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8101
Email
fatemehzargar@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fatemeh Zargar
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Hezar Jerib Street, Isfahan University of Medical Sciences and Health Services, Faculty of Medicine
City
اصفهان
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 8101
Email
fatemehzargar@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Hafez
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 33, Zanbagh 20 Ave., Zanbagh Blvd., Karaj Town
City
Karaj
Province
Alborz
Postal code
3155888586
Phone
+98 26 3253 5919
Fax
Email
maryamhafez78@gmail.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