Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000580370
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
15/02/2026
Date registered
Help: Date registered
8/05/2026
Date last updated
Help: Date last updated
8/05/2026
Date data sharing statement initially provided
Help: Data sharing statement date
8/05/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of an Educational Intervention on Internet Addiction and Sleep Hygiene Among Grade 11 and 12 School Students in Dhulikhel Municipality, Nepal.
Scientific title
Effect of an Educational Intervention on Internet Addiction and Sleep Hygiene Among Grade 11 and 12 School Students in Dhulikhel Municipality, Nepal.
Additional trial identifiers [1] 316466 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Internet Addiction 340583 0
Sleep Hygiene 340584 0
Condition category
Condition code
Mental Health 336781 336781 0 0
Other mental health disorders
Mental Health 336782 336782 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention Group Description

Participants in the intervention group will receive a combined educational intervention targeting both internet addiction and sleep hygiene behaviors. All participants allocated to the intervention group will receive both components simultaneously as an integrated school-based behavioral education package guided by the Theory of Planned Behavior.

The intervention aims to improve adolescents’ knowledge, attitudes, perceived behavioral control, and behavioral intentions related to healthy internet use and sleep practices.

Sleep Hygiene Educational Intervention

The sleep hygiene component consists of structured educational sessions focusing on healthy sleep behaviors, including maintaining regular sleep–wake schedules, reducing electronic device use before bedtime, optimizing the sleep environment, relaxation techniques, and time management practices.

Session duration: 60 minutes per session
Number of sessions: One session per week for 4 consecutive weeks (total = 4 sessions)
Mode of delivery: Face-to-face interactive group sessions conducted in classroom settings using lectures, discussions, demonstrations, and printed educational materials.

Adherence monitoring:
Participant attendance will be recorded using attendance registers, and session completion will be monitored by the facilitator using standardized session checklists.

Internet De-addiction Educational Intervention

The internet addiction component focuses on promoting responsible internet use and self-regulation skills. Topics include awareness of problematic internet use, screen-time management, goal setting, behavioral self-monitoring, coping strategies, and alternative healthy activities.

Session duration: 60 minutes per session
Number of sessions: One session per week for 4 consecutive weeks (total = 4 sessions)
Mode of delivery: Face-to-face interactive educational sessions incorporating group discussion, reflective exercises, and behavior-change activities.

Adherence monitoring:
Attendance records, participation tracking, and facilitator session completion checklists will be used to monitor adherence.

Timing of Interventions

Both sleep hygiene and internet addiction interventions will be delivered during the same intervention period to the same participants as an integrated behavioral education program. Sessions will be conducted weekly over four weeks.

Facilitator Training (ADD THIS)

Facilitators delivering the intervention will receive standardized training conducted by the principal investigator prior to implementation. The training will include orientation to study objectives, intervention content, session delivery procedures, ethical considerations, and participant engagement strategies.

Training duration: 6 hours total
Format: Face-to-face training workshop
Trainer: Principal Investigator

Allocation to Groups (Non-Randomised Study Explanation)

This study uses a quasi-experimental non-randomized controlled design. Allocation to intervention and control groups will be based on selected schools/classes to minimize contamination between participants. Random allocation is not feasible due to administrative and logistical constraints within school settings.
Intervention code [1] 333134 0
Behaviour
Intervention code [2] 333595 0
Treatment: Other
Description of the comparator or control
Comparator / Control Treatment

Participants in the control group will continue to receive the usual school curriculum and routine academic activities without exposure to the educational intervention during the study period. No structured sessions related to internet addiction or sleep hygiene will be provided to the control group during the intervention phase. Outcome assessments will be conducted at the same time points as the intervention group for comparison purposes. After completion of data collection, educational materials will be offered to control group participants for ethical considerations.
Control group
Active

Outcomes
Primary outcome [1] 345311 0
Change in Internet Addiction Test (IAT) score
Timepoint [1] 345311 0
Baseline (pre-intervention) and 6 weeks post-intervention commencement
Primary outcome [2] 345312 0
Change in Sleep Hygiene Index (SHI) score
Timepoint [2] 345312 0
Baseline (pre-intervention) and 6 weeks post-intervention commencement
Secondary outcome [1] 457448 0
Nil
Timepoint [1] 457448 0
Nil

Eligibility
Key inclusion criteria
• Students currently enrolled in Grade 11 and Grade 12 of the selected secondary schools.
• Provide informed assent and parental/guardian consent.
Minimum age
15 Years
Maximum age
30 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
• Students with diagnosed psychiatric or severe sleep disorders (self-reported)
• Students who have participated in similar awareness programs recently

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
20/02/2026
Date of last participant enrolment
Anticipated
Actual
5/04/2026
Date of last data collection
Anticipated
Actual
5/04/2026
Sample size
Target
100
Accrual to date
Final
100
Recruitment outside Australia
Country [1] 27805 0
Nepal
State/province [1] 27805 0
Bagamati Province, Nepal

Funding & Sponsors
Funding source category [1] 321077 0
Self funded/Unfunded
Name [1] 321077 0
Abindra Kshetri, Pokhara university
Country [1] 321077 0
Nepal
Primary sponsor type
Individual
Name
Abindra Kshetri, Pokhra University,School of Health & allied sciences, Pokhara, kaski
Address
Country
Nepal
Secondary sponsor category [1] 323783 0
None
Name [1] 323783 0
Address [1] 323783 0
Country [1] 323783 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319610 0
Institutional review committee, Pokhara University
Ethics committee address [1] 319610 0
Ethics committee country [1] 319610 0
Nepal
Date submitted for ethics approval [1] 319610 0
14/01/2026
Approval date [1] 319610 0
28/01/2026
Ethics approval number [1] 319610 0
77/2082/2083

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 147858 0
Mr Abindra Kshetri
Address 147858 0
Abindra Kshetri Master of Public Health Program School of Health and Allied Sciences Pokhara University Lekhnath-30, Pokhara Gandaki Province, 33700 Nepal
Country 147858 0
Nepal
Phone 147858 0
+977 9851042424
Fax 147858 0
Email 147858 0
[email protected]
Contact person for public queries
Name 147859 0
Abindra Kshetri
Address 147859 0
Abindra Kshetri Master of Public Health Program School of Health and Allied Sciences Pokhara University Lekhnath-30, Pokhara Gandaki Province, 33700 Nepal
Country 147859 0
Nepal
Phone 147859 0
+977 9851042424
Fax 147859 0
Email 147859 0
[email protected]
Contact person for scientific queries
Name 147860 0
Abindra Kshetri
Address 147860 0
Abindra Kshetri Master of Public Health Program School of Health and Allied Sciences Pokhara University Lekhnath-30, Pokhara Gandaki Province, 33700 Nepal
Country 147860 0
Nepal
Phone 147860 0
+9779851042424
Fax 147860 0
Email 147860 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
• Requires a data sharing agreement between data requester and trial custodian or sponsor
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Postal address: Banepa Municipality-07, Kavrepalanchowk, Bagamati Province, Nepal

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.