Parent-QoL and Sleep Disordered Breathing

NCT04501848 | Completed DMC

• 1 other identifier: NHR009417
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Apnea Syndromes

Outcome Measures

Primary Outcomes (1)

• A change in the PAR-ENT-QoL questionnaire score

  translated and validated the PAR-ENT-QoL questionnaire through forward-backward translation method.

  Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery

Study Arms (2)

Study

parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment

Procedure: adenotonsillectomy

Control

A group of parents to healthy children comprised the control group.

Interventions

adenotonsillectomy PROCEDURE

adenotonsillectomy surgery

Study

Eligibility Criteria

• Age: 1 Year - 5 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population included parents of children younger than five years old who suffered from OSDB and underwent tonsillectomy or tonsillotomy with or without adenoidectomy during 2018, in the Department of Otolaryngology at Galilee Medical Center, Israel. The control group was composed of parents of healthy children of the same age group who did not suffer from OSDB or any other acute or chronic disease and were recruited through an online survey to complete the questionnaire

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Western Galilee Hospital-Nahariya: lead

Study Sites (1)

Galillee medical center

Nahariya, 2210001, Israel

Location

Related Publications (4)

• Berdeaux G, Hervie C, Smajda C, Marquis P. Parental quality of life and recurrent ENT infections in their children: development of a questionnaire. Rhinitis Survey Group. Qual Life Res. 1998 Aug;7(6):501-12. doi: 10.1023/a:1008874324258.

  PMID: 9737140 BACKGROUND

• Shteinberg YH, Eisenbach N, Sela E, Gruber M, Ronen O. Translation and cultural adaptation of the Hebrew version of the Pediatric Sleep Questionnaire: a prospective, non-randomized control trial. Sleep Breath. 2021 Mar;25(1):399-410. doi: 10.1007/s11325-020-02073-6. Epub 2020 May 12.

  PMID: 32394315 BACKGROUND

• Koller M, Aaronson NK, Blazeby J, Bottomley A, Dewolf L, Fayers P, Johnson C, Ramage J, Scott N, West K; EORTC Quality of Life Group. Translation procedures for standardised quality of life questionnaires: The European Organisation for Research and Treatment of Cancer (EORTC) approach. Eur J Cancer. 2007 Aug;43(12):1810-20. doi: 10.1016/j.ejca.2007.05.029. Epub 2007 Aug 3.

  PMID: 17689070 BACKGROUND

• Wild D, Grove A, Martin M, Eremenco S, McElroy S, Verjee-Lorenz A, Erikson P; ISPOR Task Force for Translation and Cultural Adaptation. Principles of Good Practice for the Translation and Cultural Adaptation Process for Patient-Reported Outcomes (PRO) Measures: report of the ISPOR Task Force for Translation and Cultural Adaptation. Value Health. 2005 Mar-Apr;8(2):94-104. doi: 10.1111/j.1524-4733.2005.04054.x.

  PMID: 15804318 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Head and Neck Surgery Unit

Study Record Dates

• First Submitted: July 29, 2020
• First Posted: August 6, 2020
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 26, 2023

Record last verified: 2023-04

Locations

IL (1)