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NCT04501848 Clinical Trial

Parent-QoL and Sleep Disordered Breathing

Sleep Apnea Syndromes Clinical Trial

Official title:
The Impact of Sleep Disordered Breathing on Parental Quality of Life

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04501848
Other study ID # NHR009417
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2018
Est. completion date December 31, 2020

Study information
Verified date April 2023
Source Western Galilee Hospital-Nahariya
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Year to 5 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• adenotonsillectomy
adenotonsillectomy surgery

Locations
Country Name City State
Israel Galillee medical center Nahariya

Sponsors (1)
Lead Sponsor Collaborator
Western Galilee Hospital-Nahariya

Country where clinical trial is conducted

Israel, 

References & 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. — View 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. — View 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. — View 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. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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