Parent-QoL and Sleep Disordered Breathing

The Impact of Sleep Disordered Breathing on Parental Quality of Life

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04501848

Enrollment

Registered

2020-08-06

Start date

2018-01-01

Completion date

2020-12-31

Last updated

2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sleep Apnea Syndromes

Brief summary

In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who were planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprise the control group.

Detailed description

Parents of children with any chronic illness may experience increased anxiety and reduced health-related quality of life (QoL). In this study, the investigators will analyze QoL parameters among parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment. In this prospective case-control study the investigators will enrolled parents of 45 children younger than five years of age who are planned to undergo adenotonsillectomy due to an obstructive airway indication in an academic medical center. A group of parents to healthy children will comprisedthe control group. The investigators will translate and validate the PAR-ENT-QoL questionnaire through forward-backward translation method. Main outcome measure: The questionnaire was tested for reliability, consistency, reproducibility, responsiveness, and for its clinical use.

Interventions

PROCEDUREadenotonsillectomy

adenotonsillectomy surgery

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Years to 5 Years

Healthy volunteers

Yes

Inclusion criteria

* Parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy

Exclusion criteria

* We excluded parents of children who required immediate surgery or had any other chronic diseases (such as ADHD, asthma, allergic rhinitis or severe medical or mental impairments).

Design outcomes

Primary

Measure	Time frame	Description
A change in the PAR-ENT-QoL questionnaire score	Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery	translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026