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

Understanding The Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate: A Qualitative Study

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.

Study Overview

• Status: Completed
• Conditions: Cleft Lip and Palate
• Intervention / Treatment: Diagnostic test: Interview- based questionnaire

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11566
    • Faculty of dentistry, ain shams university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

Inclusion Criteria:

• Parents of Patients with non-syndromic CLP.

Exclusion Criteria:

• Parents of Patients presenting with dental pain.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Ain Shams University
• Investigators: Principal Investigator: Nagwa Mohamed Ali, Prof of PD, Ain shams university

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 7, 2022
• Primary Completion (Actual): July 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: February 2, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Actual): February 16, 2023

Study Record Updates

• Last Update Posted (Actual): September 6, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Cleft Lip and Palate; Concerns; Challenges
• Additional Relevant MeSH Terms: Congenital Abnormalities; Stomatognathic Diseases; Mouth Diseases; Lip Diseases; Mouth Abnormalities; Stomatognathic System Abnormalities; Cleft Lip
• Other Study ID Numbers: 1137

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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