Bedtime Routines and Children's Health

NCT05201924 | Completed DMC

• 1 other identifier: 202007HM010
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, the prevalence of sleep problems, myopia, and dental caries in school-age children is high. Little is known regarding the implementation of oral and vision health outcomes around bedtime. A bedtime routine intervention was conducted to improve children's oral, vision and sleep health.

Conditions

Myopia; Dental Caries; Sleep; Asthenopia

Keywords

Myopia; dental caries; bedtime routine; sleep

Outcome Measures

Primary Outcomes (6)

• the change of bedtime activities and sleep patterns

  self-administered sleep diary, including sleep patterns, screen device use 2 hours before bedtime, caffine food intake

  7 days at baseline, three month post intervention and six month post intervention

• the change of bedtime routines

  Bedtime routine questionnaire (Handerson \& Jordan, 2010): the subscale of bedtime consistency and bedtime adaptive activities

  baseline, three month post intervention and six month post intervention

• the change of children's sleep habits

  Children's sleep habits questionnaire, CSHQ (Owens et al., 2000). Higher score means more disturbed sleep. The internal consistency for both the community sample was 0.68; alpha coefficients for the various subscales of the CSHQ ranged from 0.36 (Parasomnias) to 0.70 (Bedtime Resistance) for the community sample. Test-retest reliability was acceptable (range 0.62 to 0.79).

  three month post intervention and six month post intervention

• The change of caregiver's sleep quality

  Pittsburgh Sleep Quality Index, PSQI (Buysse et al., 1989). The global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% (kappa = 0.75, p less than 0.001) in distinguishing good and poor sleepers.

  baseline, three month post intervention and six month post intervention

• The change of caregiver's daytime sleepiness

  Epworth Sleepiness Scale, ESS (Johns et al., 1991). The internal consistency as measured by Cronbach's alpha was 0.88. Higher scores means more daytimes sleepiness.

  baseline, three month post intervention and six month post intervention

• The change of pediatric daytime sleepiness

  Pediatric Daytime Sleepiness (Drake et al., 2003). Scores ranged from 0 to 32. Mean score values in the original study were 15.3 ± 6.2. Higher scores indicate greater sleepiness.

  baseline, three month post intervention and six month post intervention

Secondary Outcomes (7)

• the change of myopia

  baseline, three month post intervention and six month post intervention

• the change of stereopsis

  baseline, three month post intervention and six month post intervention

• the change of objective Asthenopia

  baseline, three month post intervention and six month post intervention

• the change of subjective Asthnopia

  baseline, three month post intervention and six month post intervention

• the change of oral pH

  baseline, three month post intervention and six month post intervention; before bedtime after brushing and rising time before brushing

Study Arms (2)

Bedtime routine

EXPERIMENTAL

A bedtime routine intervention handbook and check list, including bedtime brushing, limited sugar consumption around bedtime, reading books instead of using screen devices before bed, setting a regular bedtime, turning off the light, and reaching a 9 to 11-hour sleep duration

Behavioral: Bedtime routine

control group

ACTIVE COMPARATOR

healthy lifestyle checklist

Behavioral: Control

Interventions

Bedtime routine BEHAVIORAL

a regular routine conducted around bedtime includes brush, book reading and regular bedtime

Bedtime routine

Control BEHAVIORAL

a healthy control checklist

control group

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children whose average bedtime later than 9:30 pm
• Children who sleep less than 9 hours or more than 11 hours

You may not qualify if:

• intellectual disability prior to pre-school age diagnosed by physicians
• special education students
• less than 15 school day per month
• medications used that influence sleep
• congenital eye diseases
• dental emergencies

Sponsors & Collaborators

• National Taiwan University: lead

Study Sites (1)

Tsai, Han-Yi

Taipei, Taipei, 10051, Taiwan

Location

MeSH Terms

Conditions

Myopia; Dental Caries; Asthenopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: National Taiwan University

Model Details: An bedtime routine interventional group and a healthy lifestyle control group

Study Record Dates

• First Submitted: December 21, 2021
• First Posted: January 21, 2022
• Study Start: January 31, 2022
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)