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CompletedNCT06549868Updated Aug 12, 2024

Using Yoga to Reduce Chaos and Improve Preschooler Sleep

An interventional study of Yoga-based bedtime routine in Sleep, Inadequate and Sleep, sponsored by Emily Guseman. Completed at 1 site in United States. Open to participants aged 2 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-12.

Sponsored by Emily Guseman · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Jul 2019, registered Jul 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
2 Years and older
Sex
All
01

Study summary

The goal of this intervention study is to learn if a yoga-based bedtime routine is feasible for families to follow and to learn if the routine is effective at improving preschooler sleep. The main question it aims to answer is:

Will families be able to follow the routine regularly during the study period? Will following the yoga routine improve household chaos and preschooler sleep? Researchers will compare the yoga group to a control group to see if implementing the yoga routine works better than simple advice to read a bedtime story.

Participants will be asked to visit the lab 4 times. At the first visit, we will measure body size of parents and children, ask parents to complete some surveys, and fit each of them with an activity monitor. One week later, they will return for the second visit. At this visit, we will collect the activity monitor and assign the participants to either the intervention (yoga) or control (bedtime story) group. Families in the intervention group will learn about the intervention and be asked to follow it for the next four weeks. Families in the control group will receive a book and advice about reading stories at bedtime. After four weeks, families will return to the lab for a third visit and we will repeat the measurements from visit 1. Then, families in the intervention group will be asked to follow the yoga routine as much as they would like to for the next 4 weeks. Families in the control group will \"cross over\" to the intervention group and will follow the yoga intervention for 4 weeks. Then, families will return to the lab for a 4th visit, where we will repeat all of the measures from the first visit and the study will be complete.

02

Conditions studied

  • Sleep, Inadequate
  • Sleep

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Keywords

  • sleep
  • children
  • preschool
  • yoga
  • parents
  • household chaos
03

In context

Sleep Deprivation

300 studies on the registry are indexed under Sleep Deprivation; 60 are open to participants now.

This study's enrollment of 30 is below the median of 45 across 248 interventional studies indexed under Sleep Deprivation.

Browse Sleep Deprivation studies →

Lead sponsor

This is the only study on the registry with Emily Guseman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Children between 2.0-5.9 years of age and their self-identified primary parent/guardian

Exclusion criteria

Exclusion Criteria:

  • Parent currently pregnant Child or parent unable to walk independently Child or parent has an upper body mobility limitation that precludes completion of yoga routine
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Yoga

    Participants will be asked to follow a yoga-based bedtime routine for 4 weeks

    Behavioral: Yoga-based bedtime routine

  • Other
    Story

    Waitlist control arm. Participants will complete a 4-week control period upon randomization. After this control period is completed, they will crossover into the intervention group and follow the same 4 week intervention as the yoga group.

    Behavioral: Yoga-based bedtime routine

Interventions

  • BehavioralYoga-based bedtime routine

    Dyads in the yoga intervention group receive a picture book outlining a bedtime-themed yoga routine and are instructed to incorporate it into their bedtime routine at least four nights per week for four weeks. The routine guides children through a sequence of yoga poses, starting with the mountain pose and ending in child's pose, designed to calm them as the story progresses. Parents are given a bedtime diary to record the date, whether the child completed the yoga routine each evening, and any comments about their experience with the book. At week 6, families return to the lab, complete anthropometric assessments and questionnaires, and are fitted with accelerometers to wear for the next week. The accelerometers are returned and data is downloaded a week later. Families are then encouraged to continue using the yoga routine as often as they wish for an additional four weeks, although the frequency of use is not tracked during this maintenance period.

06

What researchers measure

Primary outcomes

  1. Intervention adherence

    Number of yoga sessions completed Percent of prescribed sessions completed

    Time frame: 4 weeks

  2. Household chaos

    Measured using Chaos, Hubbub, and Order Scale (CHAOS) at enrollment, crossover point, and study completion. A lower CHAOS score post-intervention would indicate an improvement in household chaos.

    Time frame: at week 1, week 5, and week 10

Secondary outcomes

  1. Child sleep duration

    nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion

    Time frame: at week 1, week 5, and week 10

  2. Parent sleep duration

    nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion

    Time frame: 1 week at week 1, week 5, and week 10

  3. Parent sleep quality

    nightly sleep measured by waist-worn accelerometer at enrollment, crossover point, and study completion

    Time frame: 1 week at week 1, week 5, and week 10

  4. Child sleep quality

    nightly sleep measured by waist-worn accelerometer

    Time frame: 1 week at week 1, week 5, and week 10

  5. Child sleep quality

    measured by Children's Sleep Habits Questionnaire (CSHQ; scored using mean and standard deviation of survey items. A higher CSHQ mean score indicates worse sleep quality)

    Time frame: 1 week at week 1, week 5, and week 10

07

Study locations

1 site
  • Ohio University
    Athens, Ohio 45701, United States
08

References and documents

Individual participant data

Plan to share: Undecided — This is a pilot study for a planned full-scale intervention

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06549868
Lead sponsor
Emily Guseman
Responsible party
Emily Guseman (Assistant Professor, Ohio University College of Osteopathic Medicine) — Sponsor-investigator
First posted
Aug 12, 2024
Start date
Jul 15, 2019
Primary completion
May 13, 2022
Completion
May 13, 2022
Last update
Aug 12, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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