The Effect of Sleep Hygiene and Exercise Therapy in Children With Sleep Bruxism

NCT05323942 | Completed

• 1 other identifier: 2019/92
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

The aims of this study were to determine the relationship between sleep bruxism, oral habits, and sleep habits and establish treatment approaches in children.

Conditions

Sleep Bruxism, Childhood

Keywords

Bruxism; Sleep Habits; Oral Habits; Children

Outcome Measures

Primary Outcomes (3)

• Change from Baseline in Pain at 8 weeks

  The pain was measured with the Visual Analogue Scale (VAS) and the degree of pain was questioned in various situations. The children were told to mark the value of 0 when they felt no pain, 10 when they felt excruciating pain, and to mark the pain they felt within this range. And it was supported by facial expressions. Headache when waking up in the morning, jaw pain when waking up in the morning, jaw pain while eating, jaw pain after meals, and jaw pain before going to bed at night were questioned and each was measured by VAS.

  Baseline, 8 weeks

• Change from Baseline in Children's Sleep Habits Questionnaire (CSHQ) at 8 weeks

  Children's Sleep Habits Questionnaire (CSHQ) investigate children's sleep habits and sleep-related problems, and its Turkish validity and reliability were used. After giving the necessary information about the questionnaire to the parents, they were asked to fill it out. The CSHQ has satisfactory psychometric properties in children and has been used in the investigation of sleep in children. The form consists of 33 items in total. There are eight subscales in the scale, which can be listed as bedtime resistance, delayed falling asleep, sleep duration, sleep anxiety, night awakenings, parasomnias, impaired breathing during sleep, and daytime sleepiness.

  Baseline, 8 weeks

• Change from Baseline in Oral Habits at 8 weeks

  The evaluation was made with the 21-item Oral Habits Questionnaire (OAA). Each item was evaluated according to the frequency of complaints as "4 = always; 3 = most of the time; 2 = sometimes; filled with 1 = several times or 0 = none". A person's overall score can range from 0 to 84. A low overall score indicates positive oral habit, while a higher score indicates negative oral habit. After making sure that the questions were correctly understood by the children, the markings of the answers were made by the practitioner.

  Baseline, 8 weeks

Secondary Outcomes (1)

• Change from Baseline in Temporomandibular Joint (TMJ) Range of Motion (ROM) at 8 weeks

  Baseline, 8 weeks

Study Arms (1)

Education and Exercise Therapy Group

OTHER

Children and their parents were trained about bruxism, parafunctional oral habits, and sleep hygiene education. Therapeutic exercises about head-neck posture, breathing, and relaxation were given for 8 weeks.

Other: Education and Exercise Therapy Group

Interventions

Education and Exercise Therapy Group OTHER

82 children were evaluated. Among those, 37 volunteered children were trained and demonstrated in practice about bruxism, parafunctional oral habits, sleep hygiene education, and 5x5 therapeutic exercises. Therapeutic exercises program 5x5 included breathing exercises, head-neck, and scapular posture exercises which included jaw muscle and neck muscle stretching and strengthening exercises. They were asked to repeat each exercise with 5 set and 5 times a day for 8 weeks. Sleep hygiene education was given to parents and children with explanation of the parafunctional oral habits to raise awareness about being conscious about the oral habits. Sleep hygiene education includes routines about bedtime, sleeping room environment, and timing for exercise.

Education and Exercise Therapy Group

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children between the ages of 6 - 13,
• Having a diagnosis of sleep bruxism,,
• And a parent signing informed consent for participation in the study.

You may not qualify if:

• Children who received orthodontic treatment,
• Children with the dentofacial anomaly, a history of TMJ surgery, having a medical history of neurological or psychiatric disease
• and those who could not cooperate were excluded from the study.

Sponsors & Collaborators

• Hasan Kalyoncu University: lead

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, 27410, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Bruxism; Bruxism

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Habits; Behavior

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Aysenur Tuncer, PhD

  Hasan Kalyoncu University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Faculty

Study Record Dates

• First Submitted: April 5, 2022
• First Posted: April 12, 2022
• Study Start: March 8, 2020
• Primary Completion: April 16, 2021
• Study Completion: June 30, 2021
• Last Updated: April 12, 2022

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)