Parent-QoL and Sleep Disordered Breathing

Completed

• Conditions: Sleep Apnea Syndromes
• Interventions: Procedure: adenotonsillectomy

• Registration Number: NCT04501848
• Lead Sponsor: Western Galilee Hospital-Nahariya

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.

Study Timeline

• Study Start: 2018-01-01
• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-08-03
• Study First Posted: 2020-08-06
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study	adenotonsillectomy	parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Galillee medical center; 🇮🇱 Nahariya, Israel