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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05730946
Other study ID # 1137
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 7, 2022
Est. completion date July 30, 2023

Study information

Verified date September 2023
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 12
Est. completion date July 30, 2023
Est. primary completion date July 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Parents of Patients with non-syndromic CLP. Exclusion Criteria: - Parents of Patients presenting with dental pain.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Egypt Faculty of Dentistry, Ain Shams University Cairo

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (6)

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. — View Citation

Elmouden L, Elgasmi F, Ousehal L. Quality of Life in Adolescents with Cleft Lip and Palate. In: Gülsen A, editor. Current Treatment of Cleft Lip and Palate. 2020.

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. — View Citation

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. — View Citation

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. — View Citation

Turner DW. Qualitative interview design: A practical guide for novice investigators. Qual Rep. 2010;15(3):754-60.

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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