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Investigating the Impact of Mobile-Based Education on Quality of Life, Anxiety, and Self-Care in Patients Undergoing Open Prostatectomy: A Randomized Controlled Trial Study

Protocol summary

Study aim
Determination the effect of mobile-based education on quality of life, anxiety and self-care in patients undergoing open prostatectomy between intervention and control groups
Design
A phase 3 clinical trial with a control group, featuring parallel groups, non-blinded, and randomized, was conducted on 60 patients.
Settings and conduct
Study place: Operating ward of Shaid Beheshti Hospital in Hamdan; Study population: patients with Benign prostatic hyperplasia; Type of blinding: In this study blinding was not performed
Participants/Inclusion and exclusion criteria
Inclusion criteria: candidates for open prostatectomy via the transvesical approach must be demonstrate a willingness to participate in the study, possess the ability to flow educational content and communicate with the researcher, own an android device and be proficient in its use, and have literacy skills or be accompanied by a literate individual to assist in data completion. Exclusion criteria: individuals currently participating in another clinical trial concurrently, loss of participants during the study due to death, withdrawal of consent during the study, or lack of cooperation from patients in following educational guidance will be excluded.
Intervention groups
The intervention group will receive care education through a communication application provided by the researcher. In the intervention group, assessments related to the quality of life and self-care will be conducted during visits to the physicians office. Subsequently, on the of surgery, anxiety levels will be evaluated, and after the surgery, urinary symptoms, quality of life, and self-care will be assessed at one and three-month intervals. The control group will undergo the evaluations in a similar manner, with the distinction that they receive standard educational materials instead.
Main outcome variables
Quality of life; anxiety; self-care; urinary symptoms.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201127049507N2
Registration date: 2025-03-29, 1404/01/09
Registration timing: prospective

Last update: 2025-03-29, 1404/01/09
Update count: 0
Registration date
2025-03-29, 1404/01/09
Registrant information
Name
Iman Khahan-Yazdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3661 7321
Email address
antenen@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-30, 1404/01/10
Expected recruitment end date
2025-09-21, 1404/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the Impact of Mobile-Based Education on Quality of Life, Anxiety, and Self-Care in Patients Undergoing Open Prostatectomy: A Randomized Controlled Trial Study
Public title
The Impact of Mobile Education on Quality of Life, Anxiety, and Self-Care in Patients Undergoing Prostate Surgery
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Candidate for open prostate surgery via transvesical approach Willingness to participate in the study Ability to follow up on training and communicate with researcher Possessing and android phone and the ability to operate it
Exclusion criteria:
Loss of samples during the study due to mortality Severe mental health disorders Surgery performed in the past six months
Age
To 90 years old
Gender
Male
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
A randomized controlled clinical trial, phase 3 on 60 patients, a random sequence is created by an epidemiologist by running an online program on the website (https://www.sealedenvelope.com), due to the use of codes The specialization created by the website also guarantees the allocation hiding.
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
Research Ethics Committees of Hamadan University of Medical Scieneces
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2025-03-01, 1403/12/11
Ethics committee reference number
IR.UMSHA.REC.1403.874

Health conditions studied

1

Description of health condition studied
Benign neoplasm of prostate
ICD-10 code
D29.1
ICD-10 code description
Benign neoplasm of prostate

Primary outcomes

1

Description
Quality of life in the short form of the World Health Organization quality of life questionnaire
Timepoint
Measurement of quality of life at the start of the study (prior to intervention) and at 1 and 3 months post initiation of educational interventions
Method of measurement
Short form of the World Health Organization quality of life questionnaire

2

Description
State-trait anxiety inventory score
Timepoint
Measurement of preoperative anxiety
Method of measurement
State-trait anxiety inventory

3

Description
Self-care assessment score on the Self-Care Agency Scale-Revised
Timepoint
Measurement of Self-care at the start of the study (prior to intervention) and at 1 and 3 months post initiation of educational interventions
Method of measurement
Self-care agency scale-revised

4

Description
Score of the Urinary symptom checklist
Timepoint
1 and 3 months post initiation of educational interventions
Method of measurement
Urinary symptom checklist

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: patients diagnosed with benign prostatic hyperplasia who are candidates for open prostatectomy will receive standard hospital care, in addition to educational interventions related to self care behaviors following surgery, one week prior to the surgical procedure.
Category
Rehabilitation

2

Description
Control group: patients diagnosed with benign prostatic hyperplasia who are candidates for open prostatectomy will receive only standard hospital care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital, Hamadan
Full name of responsible person
Dr. Siamak Daneshvar
Street address
Hamedan - Beginning of Eram Boulevard
City
Hamdan
Province
Hamadan
Postal code
65179-5-3371
Phone
+98 81 3838 0283
Fax
+98 81 3838 1035
Email
ShahidBeheshti@umsha.ac.ir
Web page address
https://beheshti.umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Behrouz Khanarkaei
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Iman Khahan-Yazdi
Position
Master's degree student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
antenen@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Behzad Imani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
behzadiman@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Iman Khahan-Yazdi
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hamedan, Shahid Fahmideh Blvd., Research Square, Central Headquarters of University of Medical Sciences, 5th Floor
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
antenen@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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