UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053983 |
|---|---|
| Receipt number | R000061625 |
| Scientific Title | The Efficacy of Pubertal Education Programme among Adolescent Girls: A Randomized controlled Trial |
| Date of disclosure of the study information | 2024/03/30 |
| Last modified on | 2024/03/30 02:15:07 |
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Basic information
Public title
The Efficacy of Pubertal Education Programme among Adolescent Girls: A Randomized controlled Trial
Acronym
The Efficacy of f Pubertal Education Programme among Adolescent Girls:An Intervention Based Study
Scientific Title
The Efficacy of Pubertal Education Programme among Adolescent Girls: A Randomized controlled Trial
Scientific Title:Acronym
The Efficacy of Pubertal Education Programme among Adolescent Girls: An Intervention Based Study
Region
| Asia(except Japan) |
Condition
Condition
Pubertal Awareness among Adolescence Girls
Classification by specialty
| Not applicable | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the efficacy of Pubertal changes interventional education among adolescent girls
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
To assess the efficacy of Pubertal changes and related psychological distress. The measurement tool would be Pubertal Changes Experience Scale (PCES) and Quality of life scale for children at puberty (QOLs). This outcome will be measured within 6 months.
Key secondary outcomes
It will help in assessing the efficacy of Pubertal changes interventional education in reducing emotional distress , Behavioral maturation, self care and management and quality of life among a adolescence girls.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Experimental group will receive Pubertal Changes Intervention Education Programme. This group will receive education about puberty in about 6 session. Each session will be approximately 45 minutes.
Interventions/Control_2
Control group will receive no treatment.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 10 | years-old | <= |
Age-upper limit
| 14 | years-old | >= |
Gender
Female
Key inclusion criteria
Adolescent girls who never participated in any pubertal changes education intervention and program will be included.
All girls who achieved or not achieved Menarche will be included.
Key exclusion criteria
All those girls who will not complete the assessment measures will be excluded from the sample.
The participant with diagnosed physical or mental illness will be excluded.
Adolescence girls whose parents will not allow for participation will be excluded.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Dr.Ayesha |
| Middle name | |
| Last name | Aziz |
Organization
Department of Professional Psychology Bahria University,Lahore.
Division name
Lahore, Punjab, Pakistan
Zip code
54782
Address
47-C Civic Centre, Johar Town, Block D, Lahore
TEL
0321-7030921
ayesha.bulc@bahria.edu.pk
Public contact
Name of contact person
| 1st name | Lubna |
| Middle name | Kanwal |
| Last name | Dar |
Organization
Department of Professional Psychology Bahria University, Lahore
Division name
Lahore, Punajb, Pakistan
Zip code
54782
Address
47-C Civic Centre, Johar Town, Block D, Lahore
TEL
0321-7030921
Homepage URL
lubnadar.bulc@bahria.edu.pk
Sponsor or person
Institute
Department of Professional Psychology Bahria University, Lahore.
Institute
Department
Personal name
Funding Source
Organization
non-funded research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Pakistan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bahria University Lahore, Campus
Address
47-C Civic Centre, Johar Town, Block D, Lahore
Tel
042 99233408
Khawer.bulc@bahria.edu.pk
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
60
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 03 | Month | 27 | Day |
Last modified on
| 2024 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061625
