TracheostomyNCT05739578
Caregiver Experiences With Tracheostomy
An observational study of Tracheostomy and Care Giving Burden, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to determine the experiences of primary caregivers of patients with tracheostomies on tracheostomy suctioning procedure. This is a semi-structured qualitative study. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tracheostomy, Care Giving Burden, Caregiver
- How many people
- 11 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2021to 20 Feb 2022
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eleven primary caregivers of patients who volunteered to participate in the study were included.
Who may be able to join
- Being a caregiver of patients with tracheostomy over the age of 18
- Volunteer.
- Being the primary caregiver of the patient,
- Ability to communicate verbally
- Normal psychological state.
Who cannot join
- Being a caregiver of tracheostomy patients younger than 18 years of age
- Rejecting the voluntary event,
- Not being the primary caregiver of the patient,
- Inability to communicate verbally
- Having a psychological disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Experiences of patıent's prımary Caregivers With Tracheostomy Suctioning Before Discharge
This study aimed to determine the experiences of primary caregivers of patients with tracheostomies on tracheostomy suctioning procedure. This is a semi-structured qualitative study.
Read the detailed description
The study sample consisted of eleven (11) primary caregivers of patients with tracheostomies who were hospitalized in the otolaryngology clinic of a university hospital in a province located in the northwest of Turkey. This study was conducted using a semi-structured interview technique with the primary caregivers of the patients. Interviews were audio-recorded during the data collection procedure. The content of the audio recordings obtained during each interview was evaluated by the researchers using the content analysis method. The data were categorized, coded, and analyzed by creating themes and sub-themes. It was observed that the primary caregivers of the patients expressed fear, sadness, and anxiety during the suctioning procedure performed by healthcare professionals or themselves during their hospitalization. It was determined that caregivers need information on suctioning practice and insufficient knowledge on emergencies worries them as well.
- Conditions
- Tracheostomy, Care Giving Burden, Caregiver
- Keywords
- Tracheostomy, Suctioning, Caregiver
- Medical subject headings
- Caregiver Burden
What is being measured
The primary outcome is the main question the study is designed to answer.
Experiences of patient's primary caregivers with tracheostomy suctioning before dıschange
A data collection form included 12 questions related to the sociodemographic characteristics of patients and their primary caregivers. The semi-structured interview questions were as follows;1) How did you feel when the nurse/physician performed suctioning from the tube in your patient's throat for the first time? What did you think? 2) How did you feel when you heard that this process should be continued at home? What do you think? What was your reaction? 3)How did you feel when you performed tracheal suctioning for the first time? 4) What was your reaction when you first heard that suctioning will be your responsibility at home? 5)Are there any different topics/details you want to share related to tracheostomy suctioning before discharge?
Measured: Interviews with each caregiver whose patient's discharge was planned lasted an average of 33 minutes. Interviews with a total of 11 caregivers were completed in 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Dec 2021
- Primary completion20 Feb 2022
- Study completion20 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for TracheostomyStudies of the same condition, open and under way.
- 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
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yeliz Sapulu Alakan, Uludag University
- Investigators
- Yeliz ŞAPULU ALAKAN, Principal investigator, Uudag Universty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739578
- Sponsor's protocol ID
- YSAlakan
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 22 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD
Publications
Kun SS, Davidson-Ward SL, Hulse LM, Keens TG. How much do primary care givers know about tracheostomy and home ventilator emergency care? Pediatr Pulmonol. 2010 Mar;45(3):270-4. doi: 10.1002/ppul.21169.
PubMed 20146395Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.
PubMed 25253106McCormick ME, Ward E, Roberson DW, Shah RK, Stachler RJ, Brenner MJ. Life after Tracheostomy: Patient and Family Perspectives on Teaching, Transitions, and Multidisciplinary Teams. Otolaryngol Head Neck Surg. 2015 Dec;153(6):914-20. doi: 10.1177/0194599815599525. Epub 2015 Aug 18.
PubMed 26286873Amar-Dolan LG, Horn MH, O'Connell B, Parsons SK, Roussin CJ, Weinstock PH, Graham RJ. "This Is How Hard It Is". Family Experience of Hospital-to-Home Transition with a Tracheostomy. Ann Am Thorac Soc. 2020 Jul;17(7):860-868. doi: 10.1513/AnnalsATS.201910-780OC.
PubMed 32267725Daraie S, Hasanvand S, Goudarzi F, Rassouli M. Gaining Experience Over Time: The Family Caregivers' Perception of Patients with a Tracheostomy in Home Care. Iran J Nurs Midwifery Res. 2021 Mar 5;26(2):137-143. doi: 10.4103/ijnmr.IJNMR_173_20. eCollection 2021 Mar-Apr.
PubMed 34036061
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experiences of patıent's prımary Caregivers With Tracheostomy Suctioning Before Discharge
- ClinicalTrials.gov ID
- NCT05739578
- Acronym / sponsor ID
- YSAlakan
- Conditions
- Tracheostomy, Care Giving Burden, Caregiver
- Keywords
- Tracheostomy, Suctioning, Caregiver
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 20 Feb 2022 (actual)
- First posted
- 22 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.
This study aimed to determine the experiences of primary caregivers of patients with tracheostomies on tracheostomy suctioning procedure. This is a semi-structured qualitative study.
Detailed description
The study sample consisted of eleven (11) primary caregivers of patients with tracheostomies who were hospitalized in the otolaryngology clinic of a university hospital in a province located in the northwest of Turkey. This study was conducted using a semi-structured interview technique with the primary caregivers of the patients. Interviews were audio-recorded during the data collection procedure. The content of the audio recordings obtained during each interview was evaluated by the researchers using the content analysis method. The data were categorized, coded, and analyzed by creating themes and sub-themes. It was observed that the primary caregivers of the patients expressed fear, sadness, and anxiety during the suctioning procedure performed by healthcare professionals or themselves during their hospitalization. It was determined that caregivers need information on suctioning practice and insufficient knowledge on emergencies worries them as well.
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eleven primary caregivers of patients who volunteered to participate in the study were included.
Key inclusion criteria (5 listed)
- Being a caregiver of patients with tracheostomy over the age of 18
- Volunteer.
- Being the primary caregiver of the patient,
- Ability to communicate verbally
- Normal psychological state.
Key exclusion criteria (5 listed)
- Being a caregiver of tracheostomy patients younger than 18 years of age
- Rejecting the voluntary event,
- Not being the primary caregiver of the patient,
- Inability to communicate verbally
- Having a psychological disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Experiences of patient's primary caregivers with tracheostomy suctioning before dıschange
Time frame: Interviews with each caregiver whose patient's discharge was planned lasted an average of 33 minutes. Interviews with a total of 11 caregivers were completed in 3 months.
A data collection form included 12 questions related to the sociodemographic characteristics of patients and their primary caregivers. The semi-structured interview questions were as follows;1) How did you feel when the nurse/physician performed suctioning from the tube in your patient's throat for the first time? What did you think? 2) How did you feel when you heard that this process should be continued at home? What do you think? What was your reaction? 3)How did you feel when you performed tracheal suctioning for the first time? 4) What was your reaction when you first heard that suctioning will be your responsibility at home? 5)Are there any different topics/details you want to share related to tracheostomy suctioning before discharge?
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 22 Feb 2023.
- Results publication: PubMed 20146395Kun SS, Davidson-Ward SL, Hulse LM, Keens TG. How much do primary care givers know about tracheostomy and home ventilator emergency care? Pediatr Pulmonol. 2010 Mar;45(3):270-4. doi: 10.1002/ppul.21169.
- Results publication: PubMed 25253106Loerzel VW, Crosby WW, Reising E, Sole ML. Developing the Tracheostomy Care Anxiety Relief Through Education and Support (T-CARES) Program. Clin J Oncol Nurs. 2014 Oct;18(5):522-7. doi: 10.1188/14.CJON.522-527.
- Results publication: PubMed 26286873McCormick ME, Ward E, Roberson DW, Shah RK, Stachler RJ, Brenner MJ. Life after Tracheostomy: Patient and Family Perspectives on Teaching, Transitions, and Multidisciplinary Teams. Otolaryngol Head Neck Surg. 2015 Dec;153(6):914-20. doi: 10.1177/0194599815599525. Epub 2015 Aug 18.
- Results publication: PubMed 32267725Amar-Dolan LG, Horn MH, O'Connell B, Parsons SK, Roussin CJ, Weinstock PH, Graham RJ. "This Is How Hard It Is". Family Experience of Hospital-to-Home Transition with a Tracheostomy. Ann Am Thorac Soc. 2020 Jul;17(7):860-868. doi: 10.1513/AnnalsATS.201910-780OC.
- Results publication: PubMed 34036061Daraie S, Hasanvand S, Goudarzi F, Rassouli M. Gaining Experience Over Time: The Family Caregivers' Perception of Patients with a Tracheostomy in Home Care. Iran J Nurs Midwifery Res. 2021 Mar 5;26(2):137-143. doi: 10.4103/ijnmr.IJNMR_173_20. eCollection 2021 Mar-Apr.
- Individual participant dataSharing planned: Yes. all collected IPD
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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.
Yeliz ŞAPULU ALAKAN principal investigator
Uudag Universty
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 Tracheostomy and Care Giving Burden, run by Uludag University at 1 site in Turkey (Türkiye).
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 5 inclusion and 5 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 22 Feb 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 Turkey (Türkiye). 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?
Experiences of patient's primary caregivers with tracheostomy suctioning before dıschange (time frame: Interviews with each caregiver whose patient's discharge was planned lasted an average of 33 minutes. Interviews with a total of 11 caregivers were completed in 3 months.). 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 NCT05739578, which also lists 5 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 22 Feb 2023.