Clinical trial NCT04501848: Parent-QoL and Sleep Disordered Breathing
Official title: The Impact of Sleep Disordered Breathing on Parental Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Apnea Syndromes
Lead sponsor: Western Galilee Hospital-Nahariya
Sponsor class: OTHER_GOV
First posted: 2020-08-06
Enrollment: 45
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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).

Primary outcomes:
measure: A change in the PAR-ENT-QoL questionnaire score
timeFrame: Change from PAR-ENT-QoL questionnaire score, 1-3 weeks before surgery to 3-9 weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Nahariya
country: Israel
facility: Galillee medical center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.