Cleft Lip and Palate Clinical Trial
Official title:
Understanding The Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate: A Qualitative Study
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 |
Verified date | September 2023 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Faculty of Dentistry, Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
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.
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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