Nursing CariesNCT05388799
The Effect of Brochure-Based Education on Patients Planned for Nose Surgery
A study testing Educational intervention in people with Nursing Caries, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 1 Feb 2023
- Phase
- Interventional
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and over, 65 years and under,
- Being literate,
- To be able to understand and speak Turkish
- First time nose surgery,
- Agreeing to participate in the research.
Who cannot join
- Having any psychiatric disorder that may reduce the ability to comprehend and understand
- The surgery was canceled for some reason.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Hatay Mustafa Kemal University Institute of Health Sciences
Hatay
About this study
Official title: The Effect of Brochure-Based Education on Surgical Fear and Anxiety in Patients Planned for Nose Surgery
The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. The sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.The data of the study were collected by using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale, which were prepared in line with the literature.The data will be analyzed with the SPSS package program.
- Conditions
- Nursing Caries
- Being tested
- Educational intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational interventionOther
In addition to standard care, brochure-supported education will be given to patients who are scheduled for nose surgery.
| Study group | Role | What they receive |
|---|---|---|
| application group | Experimental | Before the operation, training will be given in line with the training brochure prepared by the researcher in the outpatient clinic and the printed version of the training brochure will be given to the patient. The training will be repeated by calling the patients the day before the surgery. Receives: Other: Educational intervention |
| control group | No intervention | Standard care will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of preoperative care on surgical fear in patients scheduled for nasal surgery
It will be evaluated with the 8-item Surgical Fear Scale, which was adapted into Turkish by Bağdigen and Karaman Özlü in 2016.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery.The score obtained from the items of the scale ranges from 0 to 10 (0 "I am not afraid at all", 10 "I am very afraid").The lowest score that can be obtained from the scale is 0, while the highest score is 80.The higher the score, the higher the patient's fear of surgery.
Measured: six months
The effect of preoperative care on surgical anxiety in patients scheduled for nasal surgery
It will be evaluated with the 17-item Surgical Anxiety Scale adapted into Turkish by Göl and Bölükbaş.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery. The scale is in a five-point Likert type, scored as "never-0", "very little-1", "moderately-2", "very-3" and "extremely-4". The lowest score that can be obtained from the scale is 0, and the highest score is 68, and the higher the score, the higher the level of surgical anxiety.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Aug 2022
- Primary completion1 Sep 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nursing CariesStudies of the same condition, open and under way.
- More trials run by Cukurova 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevgi Deniz Dogan, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388799
- Sponsor's protocol ID
- 312256940
- Status last verified
- Aug 2023
- First submitted
- 17 May 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brochure-Based Education on Surgical Fear and Anxiety in Patients Planned for Nose Surgery
- ClinicalTrials.gov ID
- NCT05388799
- Acronym / sponsor ID
- 312256940
- Conditions
- Nursing Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 24 May 2022 (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.
The study was planned as a randomized controlled trial to determine the effect of brochure-based education on fear and anxiety in patients scheduled for nose surgery.It is planned to collect research data in Hatay Mustafa Kemal University Hospital otorhinolaryngology clinic between June 2022 and June 2023.The population of the research will be the patients who are hospitalized in the otorhinolaryngology clinic of the aforementioned hospital and are planned for nasal surgery. The sample of the study, on the other hand, will consist of 52 patients who meet the inclusion criteria and agree to participate in the study verbally and in writing.The data of the study were collected by using the Personal Information Form, the Surgical Fear Scale and the Surgical Anxiety Scale, which were prepared in line with the literature.The data will be analyzed with the SPSS package program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| application group | Experimental | Other: Educational interventionBefore the operation, training will be given in line with the training brochure prepared by the researcher in the outpatient clinic and the printed version of the training brochure will be given to the patient. The training will be repeated by calling the patients the day before the surgery. |
| control group | No intervention | –Standard care will be applied. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 years and over, 65 years and under,
- Being literate,
- To be able to understand and speak Turkish
- First time nose surgery,
- Agreeing to participate in the research.
Key exclusion criteria (2 listed)
- Having any psychiatric disorder that may reduce the ability to comprehend and understand
- The surgery was canceled for some reason.
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 |
|---|---|---|
| Educational interventionIn addition to standard care, brochure-supported education will be given to patients who are scheduled for nose surgery. | Other | application group |
Primary outcome
The effect of preoperative care on surgical fear in patients scheduled for nasal surgery
Time frame: six months
It will be evaluated with the 8-item Surgical Fear Scale, which was adapted into Turkish by Bağdigen and Karaman Özlü in 2016.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery.The score obtained from the items of the scale ranges from 0 to 10 (0 "I am not afraid at all", 10 "I am very afraid").The lowest score that can be obtained from the scale is 0, while the highest score is 80.The higher the score, the higher the patient's fear of surgery.
The effect of preoperative care on surgical anxiety in patients scheduled for nasal surgery
Time frame: six months
It will be evaluated with the 17-item Surgical Anxiety Scale adapted into Turkish by Göl and Bölükbaş.It will be evaluated in the outpatient clinic before the surgery and in the clinic on the morning of the surgery. The scale is in a five-point Likert type, scored as "never-0", "very little-1", "moderately-2", "very-3" and "extremely-4". The lowest score that can be obtained from the scale is 0, and the highest score is 68, and the higher the score, the higher the level of surgical anxiety.
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 8 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Nursing Caries, run by Cukurova 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 2 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 8 Aug 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?
The effect of preoperative care on surgical fear in patients scheduled for nasal surgery (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2023.