Using Yoga to Reduce Chaos and Improve Preschooler Sleep

August 8, 2024 updated by: Emily Guseman

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.

Study Overview

Status

Completed

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Athens, Ohio, United States, 45701
        • Ohio University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Yoga
Participants will be asked to follow a yoga-based bedtime routine for 4 weeks

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.

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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention adherence
Time Frame: 4 weeks
Number of yoga sessions completed Percent of prescribed sessions completed
4 weeks
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.
at week 1, week 5, and week 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at week 1, week 5, and week 10
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
1 week at week 1, week 5, and week 10
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
1 week at week 1, week 5, and week 10
Child sleep quality
Time Frame: 1 week at week 1, week 5, and week 10
nightly sleep measured by waist-worn accelerometer
1 week at week 1, week 5, and week 10
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)
1 week at week 1, week 5, and week 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2019

Primary Completion (Actual)

May 13, 2022

Study Completion (Actual)

May 13, 2022

Study Registration Dates

First Submitted

July 24, 2024

First Submitted That Met QC Criteria

August 8, 2024

First Posted (Actual)

August 12, 2024

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a pilot study for a planned full-scale intervention

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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