Parent-QoL and Sleep Disordered Breathing

The Impact of Sleep Disordered Breathing on Parental Quality of Life

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.

Study Overview

• Status: Completed
• Conditions: Sleep Apnea Syndromes
• Intervention / Treatment: Procedure: adenotonsillectomy

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 Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• Israel
  • Nahariya, Israel, 2210001
    • Galillee medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: Yes

• 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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Study; parents of obstructive sleep disordered breathing (OSDB) children before and after surgical treatment	Procedure: adenotonsillectomy; adenotonsillectomy surgery
Control; A group of parents to healthy children comprised the control group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Western Galilee Hospital-Nahariya

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 6, 2020

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes
• Other Study ID Numbers: NHR009417

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No