NCT06004778

Brief Summary

It was planned as a randomized controlled experimental study with a single-blind technique, pretest-posttest control group and repetitive measurements, in order to determine the effect of motivational support program applied to adolescents and education on sleep quality.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
22 days until next milestone

Study Start

First participant enrolled

September 13, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 19, 2024

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

4 months

First QC Date

July 20, 2023

Last Update Submit

August 21, 2023

Conditions

High School 11th Grade StudentsAbsence of Any Language, Hearing, Mental or Psychological DisabilityTurkish Speaking and UnderstandingHaving a PUKI Index Above 5ıAbsence of Any Chronic DiseaseObtaining Permission From Parents and Students

Outcome Measures

Primary Outcomes (1)

  • Sleep quality Score

    Adolescents receiving motivational support programs have higher average sleep quality scores.

    up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)

Secondary Outcomes (1)

  • Academic Achievement Score

    up to 2 months (1 OCTOBER 2023-30 NOVEMBER 2023)

Study Arms (2)

Motivational Support Program

EXPERIMENTAL

Training booklet will be provided.A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.Individual motivational interviews will be held with students and reminder messages will be sent twice a week.

Behavioral: Motivational Support Program

educational support

ACTIVE COMPARATOR

Training booklet will be provided. A total of 5 sessions of sleep training will be given by dividing them into groups of 30 minutes, 3 days a week for 2 weeks.

Behavioral: Educational support

Interventions

Motivational Support ProgramBEHAVIORAL

In studies conducted on adolescents with poor sleep quality, no study using motivational interviewing technique was found.

Motivational Support Program
Educational supportBEHAVIORAL

educational support

educational support

Eligibility Criteria

Age16 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • No language disorders
  • No hearing disorders
  • No mental disorders
  • Bad sleep quality
  • No chronic disease

You may not qualify if:

  • Sleeping pill
  • Psychiatric illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Demet Sökün Ayaz

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Training Support

Intervention Hierarchy (Ancestors)

Financial SupportEconomicsHealth Care Economics and Organizations

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

July 20, 2023

First Posted

August 22, 2023

Study Start

September 13, 2023

Primary Completion

January 19, 2024

Study Completion

January 19, 2024

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

TU(1)