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CompletedNCT05730946Updated Sep 6, 2023

Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate

An observational study in Cleft Lip and Palate, sponsored by Ain Shams University. Completed at 1 site in Egypt. Per ClinicalTrials.gov, last updated 2023-09-06.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
12
Sex
All
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Study summary

Cleft lip and/or palate (CLP) are the most common oro-facial congenital anomalies. These anomalies have an impact on feeding, speech and speech development, facial aesthetics \& oral health, all of which are factors that heavily impact the quality of life of CLP patients. CLP also has an effect on the families' social and psychological health.

Qualitative research helps understand the perspectives of the participants by exploring the psycho-social aspects of care. Phenomenological approach is a qualitative research method that aims to borrow participants' lived experiences to better understand a specific phenomenon. Currently, there is no clear understanding of the fears, anxieties, and challenges faced by parents of CLP patients in Egypt.

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Conditions studied

  • Cleft Lip and Palate

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Keywords

  • Cleft Lip and Palate
  • Challenges
  • Concerns
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In context

Cleft Lip

162 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.

This study's enrollment of 12 is below the median of 100 across 45 observational studies indexed under Cleft Lip.

Browse Cleft Lip studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Egyptian parents of CLP patients presented to cleft lip \& palate clinic at Ain Shams university.

Inclusion criteria

  • Parents of Patients with non-syndromic CLP.

Exclusion criteria

Exclusion Criteria:

  • Parents of Patients presenting with dental pain.
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Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
12 participants (actual)
Patient registry
No

Groups and cohorts

  • Egyptian parents of cleft lip and/ or palate (CLP) patients

    Egyptian parents of CLP patients presented to the cleft lip \& palate clinic at Ain Shams university.

    Diagnostic Test: Interview- based questionnaire

Interventions

  • Diagnostic testInterview- based questionnaire

    Interview-based questionnaire by the use of an interview guide to explore and understand the Challenges faced in the past and the concerns for the future experienced by parents of CLP patients.

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What researchers measure

Primary outcomes

  1. Challenges & concerns faced by the parents of CLP patients

    The tool of measurement in the present qualitative study is In-depth interviews utilizing an interview guide (questionnaire). The recorded interviews will be transcribed by one of the authors after which thematic data analysis will be conducted. Codes will be developed by two researchers individually and intercoder meetings will held to encourage intercoder reliability.

    Time frame: 1 year

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Study locations

1 site
  • Faculty of Dentistry, Ain Shams University
    Cairo, 11566, Egypt
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References and documents

Publications

  • Johansson B, Ringsberg KC. Parents' experiences of having a child with cleft lip and palate. J Adv Nurs. 2004 Jul;47(2):165-73. doi: 10.1111/j.1365-2648.2004.03075.x. PubMed 15196190 ↗
  • Ghirotto L, De Panfilis L, Di Leo S. Health professionals learning qualitative research in their workplace: a focused ethnography. BMC Med Educ. 2020 Aug 17;20(1):269. doi: 10.1186/s12909-020-02191-5. PubMed 32807161 ↗
  • Baker C, Wuest J, Stern PN. Method slurring: the grounded theory/phenomenology example. J Adv Nurs. 1992 Nov;17(11):1355-60. doi: 10.1111/j.1365-2648.1992.tb01859.x. PubMed 1430643 ↗
  • Hennink M, Kaiser BN. Sample sizes for saturation in qualitative research: A systematic review of empirical tests. Soc Sci Med. 2022 Jan;292:114523. doi: 10.1016/j.socscimed.2021.114523. Epub 2021 Nov 2. PubMed 34785096 ↗
  • Turner DW. Qualitative interview design: A practical guide for novice investigators. Qual Rep. 2010;15(3):754-60.
  • Elmouden L, Elgasmi F, Ousehal L. Quality of Life in Adolescents with Cleft Lip and Palate. In: Gülşen A, editor. Current Treatment of Cleft Lip and Palate. 2020.

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 6, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05730946
Lead sponsor
Ain Shams University
Responsible party
Alaa Mohammed Yehia (Assistant Lecturer at Pediatric Dentistry and Dental Public Health Department, Faculty of Dentistry, Ain Shams University) — Principal investigator
First posted
Feb 16, 2023
Start date
Jul 7, 2022
Primary completion
Jul 30, 2023
Completion
Jul 30, 2023
Last update
Sep 6, 2023

Study contacts

Nagwa Mohamed Ali, Prof of PD
principal investigator · Ain Shams University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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