UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055678 |
|---|---|
| Receipt number | R000063627 |
| Scientific Title | Effect of counselling intervention in decreasing school-based stress among special educators |
| Date of disclosure of the study information | 2024/09/30 |
| Last modified on | 2024/09/30 14:00:09 |
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Basic information
Public title
Effect of counselling intervention in decreasing school-based stress among special educators
Acronym
Counselling intervention in decreasing school-based stress
Scientific Title
Effect of counselling intervention in decreasing school-based stress among special educators
Scientific Title:Acronym
Counselling intervention in decreasing school-based stress
Region
| Africa |
Condition
Condition
Occupational stress
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study sought the understanding and perception of special educators and the possible impact of counselling intervention in decreasing school stress built up as a result of huge workloads, psychological pressures, and physical demands in schoolwork.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Teachers Job Stressor Scale
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
The Cognitive-behavior-aid counselling program was administered to the treatment group. While the control group was exposed to normal conventional teaching by a school counsellor. The treatment lasted for 8 weeks following a one-week follow-up assessment after two months that led to the third assessment (Time 3).
Interventions/Control_2
They were designated to receive normal counselling that lasted for 12 weeks.
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
| 25 | years-old | < |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The teachers who expressed readiness to participate were allowed to participate
Key exclusion criteria
the teachers who not expressed readiness to participate were allowed to participate
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Mercy |
| Middle name | Benedette Ifeoma |
| Last name | Uba |
Organization
Alex Ekwueme Federal University, Ikwo,
Division name
University
Zip code
410001
Address
Alex Ekwueme Federal University, Ikwo,
TEL
+2348034278834
onyemaechi.moses@gmail.com
Public contact
Name of contact person
| 1st name | Moses |
| Middle name | Onyemaechi |
| Last name | Ede |
Organization
University of Nigeria
Division name
University
Zip code
410001
Address
University of Nigeria
TEL
+2347066725165
Homepage URL
onyemaechi.moses@gmail.com
Sponsor or person
Institute
Alex Ekwueme Federal University, Ikwo
Institute
Department
Personal name
Mercy Benedette Ifeoma Uba
Funding Source
Organization
Alex Ekwueme Federal University, Ikwo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Nigeria
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Alex Ekwueme Federal University, Ikwo
Address
Alex Ekwueme Federal University, Ikwo
Tel
+2348034278834
onyemaechi.moses@gmail.com
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
Alex Ekwueme Federal University, Ikwo
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 09 | Month | 30 | Day |
Related information
URL releasing protocol
No URL
Publication of results
Unpublished
Result
URL related to results and publications
No URL
Number of participants that the trial has enrolled
80
Results
The findings showed a significant decrease in negative perception of work-related stress by special educators and were due to exposure to counselling intervention.
Results date posted
| 2024 | Year | 09 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
High work stress
Participant flow
Nil
Adverse events
No adverse effect
Outcome measures
Teachers Job Stressor Scale
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 14 | Day |
Date of closure to data entry
| 2021 | Year | 11 | Month | 19 | Day |
Date trial data considered complete
| 2022 | Year | 02 | Month | 04 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 26 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 09 | Month | 30 | Day |
Last modified on
| 2024 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063627
