NCT05828290

Brief Summary

This study was planned to determine the effect of the "Little Yogis Doing Yoga" Program, which will be created within the scope of the research, on getting children aged 5-6 years old to sleep habits. This study was planned in a pretest, posttest design, follow-up, randomized controlled study. The sample of the study will consist of 36 children (18 children in the intervention group, 18 children in the control group) in the 5-6 age group in Antalya between 15 March and 15 June 2023. The "Little Yogis Doing Yoga" Program, which was created within the scope of the research, will be applied to the children in the intervention group in two groups, two days a week, for 4 weeks, 30 minutes each, by the researcher who received child yoga specialization training. Data will be collected with Child and Family Information Form and Child Sleep Habits Questionnaire-CSHQ). CSHQ, T0-Pretest (Before the Program "Little Yogis Doing Yoga"), T1-Interim follow-up (after the program ends) and T2-Posttest (1 month after the program is completed) will be filled by the parents. Statistical Package for the Social Sciences (SPSS) 24.0 package program will be used in the analysis of the data.

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
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 25, 2023

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

1 month

First QC Date

April 12, 2023

Last Update Submit

April 27, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Children's Sleep Habits Questionnaire (CSHQ)

    To gain children the ability to sleep habits. The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total. In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33). A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.

    CSHQ score will evaluate at baseline

  • Children's Sleep Habits Questionnaire (CSHQ)

    To gain children the ability to sleep habits. The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total. In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33). A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.

    CSHQ score will evaluate one month later

  • Children's Sleep Habits Questionnaire (CSHQ)

    To gain children the ability to sleep habits. The Children's Sleep Habits Questionnaire (CSHQ)- Abbreviated Form developed by Owens et al. consists of 33 items in total. In the scale, bedtime resistance (1,3,4,5,6,8 items), delay in falling asleep (2nd item), sleep duration (9,10,11 items), sleep anxiety (5,7,8, 21st items), night awakenings (items 16,24,25), parasomnias (12,13,14,15,17,22,23), disruption of breathing during sleep (items 18,19,20), day Eight subscales were defined as sleepiness (items 26,27,28,29,30,31,32,33). A total of 41 points is considered the cutoff point, and values above this are considered 'clinically significant'.

    CSHQ score will evaluate two month later

Study Arms (2)

Yoga Group

EXPERIMENTAL

The "Little Yogis Doing Yoga" Program was started to be implemented by the researcher for 4 weeks, 2 days a week for 30 minutes, separately for each group, in a way to form 2 groups.

Behavioral: Child Yoga

Control Group

NO INTERVENTION

Children in the control group will continue their routine education at school.

Interventions

Child YogaBEHAVIORAL

The children's yoga consists of compositions such as playing, stories, postures, breathing exercises, imitations things in nature, memory games, music, dance and daydreaming.

Yoga Group

Eligibility Criteria

Age5 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • years old
  • No school attendance problems
  • Those who have the cognitive ability to carry out the commands given during child yoga.
  • Having no physical problems that may prevent active participation in children's yoga
  • Children who do not have an obstacle to communication (sight, hearing problems, etc.) and whose parents' consent to participate in the study are approved

You may not qualify if:

  • Children who are actively attending any children's yoga program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aysegul ISLER DALGIC

Antalya, Konyaaltı, 07058, Turkey (Türkiye)

RECRUITING

Study Officials

  • Fatma Nur Ünver, RN

    Akdeniz University

    STUDY CHAIR

Central Study Contacts

Aysegul I Dalgic, Prof.

CONTACT

Fatma Nur Ünver, RN

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
At the end of the research, the groups will be coded as "A" and "B". Statistical analysis will be made by the statistics expert who is blinded to the groups in the study.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: pretest, posttest design, follow-up, randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 25, 2023

Study Start

March 31, 2023

Primary Completion

May 1, 2023

Study Completion

June 1, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations