Cleft Lip and PalateNCT05730946
Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate
An observational study of Cleft Lip and Palate, run by Ain Shams University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Interview- based questionnaire
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2022to 30 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Egyptian parents of CLP patients presented to cleft lip \& palate clinic at Ain Shams university.
Who may be able to join
- Parents of Patients with non-syndromic CLP.
Who cannot join
- Parents of Patients presenting with dental pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Cleft Lip and Palate
- Being tested
- Interview- based questionnaire
- Keywords
- Cleft Lip and Palate, Challenges, Concerns
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interview- based questionnaireDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Interview- based questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start7 Jul 2022
- Primary completion30 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mohammed Yehia, Ain Shams University
- Investigators
- Nagwa Mohamed Ali, Prof of PD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730946
- Sponsor's protocol ID
- 1137
- Status last verified
- Sep 2023
- First submitted
- 2 Feb 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 15196190Ghirotto 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 32807161Baker 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 1430643Hennink 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 34785096Turner 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 at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding The Challenges and Concerns Faced by Parents of Children With Cleft Lip and/or Palate: A Qualitative Study
- ClinicalTrials.gov ID
- NCT05730946
- Acronym / sponsor ID
- 1137
- Conditions
- Cleft Lip and Palate
- Keywords
- Cleft Lip and Palate, Challenges, Concerns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Egyptian parents of cleft lip and/ or palate (CLP) patients | – | Diagnostic Test: Interview- based questionnaireEgyptian parents of CLP patients presented to the cleft lip \& palate clinic at Ain Shams university. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Egyptian parents of CLP patients presented to cleft lip \& palate clinic at Ain Shams university.
Key inclusion criteria (1 listed)
- Parents of Patients with non-syndromic CLP.
Key exclusion criteria (1 listed)
- Parents of Patients presenting with dental pain.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interview- based questionnaireInterview-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. | Diagnostic test | Egyptian parents of cleft lip and/ or palate (CLP) patients |
Primary outcome
Challenges & concerns faced by the parents of CLP patients
Time frame: 1 year
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
- Background: PubMed 15196190Johansson 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.
- Background: PubMed 32807161Ghirotto 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.
- Background: PubMed 1430643Baker 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.
- Background: PubMed 34785096Hennink 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.
- BackgroundTurner DW. Qualitative interview design: A practical guide for novice investigators. Qual Rep. 2010;15(3):754-60.
- BackgroundElmouden 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 dataSharing planned: No
Related trials for Cleft Lip and Palate
Not yet recruiting
Comparative Study of Regional Nerve Blocks in Primary Cleft Palate Repair
Cleft Lip, Cleft Palate +/- Lip
Not yet recruiting
Quadratus Lumborum Block for Iliac Bone Harvest in Pediatric Cleft Alveolus Repair
Cleft Lip Palate
RecruitingObservational study
Perceptions of High and Low Intensity Speech Intervention in Children With a Cleft Palate
Cleft Lip and Palate, Cleft Palate Children
Not yet recruitingPhase 3
Safety and Efficacy of Bone Bioengineering Kit With Stem Cells for Alveolar Cleft Repair
Cleft Lip Palate
Enrolling by invitation
Speech Intervention Frameworks in Cantonese-speaking Children and Adolescences With Cleft Palate +/- Lip
Cleft Palate +/- Lip
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nagwa Mohamed Ali, Prof of PD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Challenges & concerns faced by the parents of CLP patients (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05730946, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.