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Completed

NCT Number: NCT06549868

Using Yoga to Reduce Chaos and Improve Preschooler Sleep

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.

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Key information

Conditions

Sleep, Inadequate Dyssomnias Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Sleep Deprivation Sleep Wake Disorders

Age range

2 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio University

Athens, Ohio, 45701, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

Yoga-based bedtime routine

Behavioral

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.

Primary outcomes

  1. Intervention adherence

    Time frame: 4 weeks

    Number of yoga sessions completed Percent of prescribed sessions completed

  2. Household chaos

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

    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.

Secondary outcomes

  1. Child sleep duration

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

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

  2. Parent sleep duration

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

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

  3. Parent sleep quality

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

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

  4. Child sleep quality

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

    nightly sleep measured by waist-worn accelerometer

  5. Child sleep quality

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

    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)

Sponsors and collaborators

Lead sponsor

Emily Guseman

Other

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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