Clinical Comfort and WorryNCT07405580
The Effect of the Excellence Model-Based Clinical Practice Preparation Program on Students
A study testing Educational intervention in people with Clinical Comfort and Worry and Readiness Levels for Clinical Practice, run by Pamukkale University.
Trial summary
Objective: This study was designed to develop a clinical practice preparation program based on the Pediatric Nursing Excellence Model for undergraduate nursing students and to evaluate the program's effect on students' readiness, clinical comfort and anxiety, and levels of excellence. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Clinical Comfort and Worry, Readiness Levels for Clinical Practice, Pediatric Nursing Excellence Level
- What is being tested?
- Educational intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 16 Feb 2026to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Being a nursing student,
- Taking the Child Health and Nursing course for the first time,
- Attending the course,
- Not having previously taken pediatric nursing readiness training,
- Agreeing to participate in the study voluntarily.
Who cannot join
- The student's refusal to participate in the study,
- Withdrawal from the study before completing all stages of the research.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
SEBAHAT ALTUNDAĞ contact
About this study
Official title: The Effect of a Preparation Program for Clinical Practice Based on the Excellence Model on Students' Readiness, Excellence, Clinical Comfort, and Anxiety Levels: A Randomized Controlled Trial
Objective: This study was designed to develop a clinical practice preparation program based on the Pediatric Nursing Excellence Model for undergraduate nursing students and to evaluate the program's effect on students' readiness, clinical comfort and anxiety, and levels of excellence.
Method: This study is a pretest-posttest randomized controlled experimental study. The research is planned to be conducted with nursing students taking the Pediatric Health and Disease Nursing course. The study groups will consist of students who go out for clinical practice within the scope of this course. In the power analysis performed with the G*Power 3.1.9.7 program, the sample size was found to be 25 for the experimental group and 25 for the control group, for a total of 50. Research data will be collected using a questionnaire. The questionnaire consists of four sections containing the following questions: "Student Descriptive Characteristics Information Form," "Nursing Students' Readiness for Clinical Practice Scale," "Pediatric Nursing Students' Clinical Comfort and Anxiety Instrument," and "Pediatric Nursing Excellence (PHM) Model Questionnaire." In the study, students in the experimental group will receive routine orientation training and a clinical practice readiness program based on the excellence model. Students in the control group will only receive routine orientation training. Data analysis will be performed using the SPSS 20.0 software package.
- Conditions
- Clinical Comfort and Worry, Readiness Levels for Clinical Practice, Pediatric Nursing Excellence Level, Nursing Student
- 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 the study, students in the experimental group will undergo a clinical practice preparation program based on the excellence model, unlike those in the control group.
| Study group | Role | What they receive |
|---|---|---|
| routine orientation training and a clinical practice readiness program based on the excellence model | Experimental | Not described Receives: Other: Educational intervention |
| routine orientation training | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Students' Readiness Levels for Clinical Practice
The assessment will be conducted using the 'Clinical Readiness Scale' developed by Avşar et al. (2024). The scale consists of 4 sub-dimensions and a total of 31 items: "Clinical Decision-Making and Application Skills," "Ensuring Safety and Effective Communication," "Basic Knowledge and Holistic Care," and "Understanding the Field of Practice." The scale is scored on a 5-point Likert scale as "strongly disagree (1)", "disagree", "somewhat agree", 'agree', and "strongly agree (5)". The scale is calculated based on the item mean score. The lowest possible score on the scale and its subscales is 1, and the highest possible score is 5. There are no reverse items on the scale. The Cronbach's alpha coefficient for the entire scale was determined to be 0.964. As the score on the scale increases, the level of readiness for clinical practice increases.
Measured: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
Secondary outcomes (2)
Students' Clinical Comfort and Worry
The 'Pediatric Nursing Students Clinical Comfort and Worry Scale' developed by Arslan et al. (2018) will be used for evaluation. The scale has two subscales: comfort level and worry level. The scale consists of a total of 11 questions, six of which assess students' comfort level during pediatric clinic practice, and five of which assess their worry level. The scale is scored on a 4-point Likert scale as "strongly agree," "agree," "disagree," and "strongly disagree." The third and fifth items in the comfort dimension of the scale are reverse-scored. The Cronbach's alpha coefficient for the comfort dimension of the scale was found to be 0.68, and the Cronbach's alpha coefficient for the worry dimension was found to be 0.89. High scores on the comfort and worry dimensions indicate higher levels of comfort and worry, respectively.
Measured: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
Pediatric Nursing Excellence Level
Students' levels of excellence in pediatric nursing will be assessed using the "Pediatric Nursing Excellence Model Questionnaire" prepared by the researchers. This questionnaire will be adapted from the original framework of the Pediatric Nursing Excellence (PH) model, which is based on and related to the relevant literature.
Measured: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start16 Feb 2026 (estimated)
- Primary completion16 Jun 2026 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical Comfort and WorryStudies of the same condition, open and under way.
- More trials run by Pamukkale 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Öğr. Gör. Hamide COŞKUN ERÇELİK, Pamukkale University
- Investigators
- SEBAHAT ALTUNDAĞ, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405580
- Sponsor's protocol ID
- PAMUKKALEU-COSKUNERCELİK-001
- Status last verified
- Feb 2026
- First submitted
- 5 Feb 2026
- Last updated
- 19 Feb 2026
- 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 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Preparation Program for Clinical Practice Based on the Excellence Model on Students' Readiness, Excellence, Clinical Comfort, and Anxiety Levels: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07405580
- Acronym / sponsor ID
- PAMUKKALEU-COSKUNERCELİK-001
- Conditions
- Clinical Comfort and Worry, Readiness Levels for Clinical Practice, Pediatric Nursing Excellence Level, Nursing Student
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 16 Feb 2026 (estimated)
- Primary completion
- 16 Jun 2026 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 12 Feb 2026 (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.
Objective: This study was designed to develop a clinical practice preparation program based on the Pediatric Nursing Excellence Model for undergraduate nursing students and to evaluate the program's effect on students' readiness, clinical comfort and anxiety, and levels of excellence.
Method: This study is a pretest-posttest randomized controlled experimental study. The research is planned to be conducted with nursing students taking the Pediatric Health and Disease Nursing course. The study groups will consist of students who go out for clinical practice within the scope of this course. In the power analysis performed with the G*Power 3.1.9.7 program, the sample size was found to be 25 for the experimental group and 25 for the control group, for a total of 50. Research data will be collected using a questionnaire. The questionnaire consists of four sections containing the following questions: "Student Descriptive Characteristics Information Form," "Nursing Students' Readiness for Clinical Practice Scale," "Pediatric Nursing Students' Clinical Comfort and Anxiety Instrument," and "Pediatric Nursing Excellence (PHM) Model Questionnaire." In the study, students in the experimental group will receive routine orientation training and a clinical practice readiness program based on the excellence model. Students in the control group will only receive routine orientation training. Data analysis will be performed using the SPSS 20.0 software package.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| routine orientation training and a clinical practice readiness program based on the excellence model | Experimental | Other: Educational intervention |
| routine orientation training | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Being a nursing student,
- Taking the Child Health and Nursing course for the first time,
- Attending the course,
- Not having previously taken pediatric nursing readiness training,
- Agreeing to participate in the study voluntarily.
Key exclusion criteria (2 listed)
- The student's refusal to participate in the study,
- Withdrawal from the study before completing all stages of the research.
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 the study, students in the experimental group will undergo a clinical practice preparation program based on the excellence model, unlike those in the control group. | Other | routine orientation training and a clinical practice readiness program based on the excellence model |
Primary outcome
Students' Readiness Levels for Clinical Practice
Time frame: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
The assessment will be conducted using the 'Clinical Readiness Scale' developed by Avşar et al. (2024). The scale consists of 4 sub-dimensions and a total of 31 items: "Clinical Decision-Making and Application Skills," "Ensuring Safety and Effective Communication," "Basic Knowledge and Holistic Care," and "Understanding the Field of Practice." The scale is scored on a 5-point Likert scale as "strongly disagree (1)", "disagree", "somewhat agree", 'agree', and "strongly agree (5)". The scale is calculated based on the item mean score. The lowest possible score on the scale and its subscales is 1, and the highest possible score is 5. There are no reverse items on the scale. The Cronbach's alpha coefficient for the entire scale was determined to be 0.964. As the score on the scale increases, the level of readiness for clinical practice increases.
2 secondary outcomes
Students' Clinical Comfort and Worry
Time frame: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
Pediatric Nursing Excellence Level
Time frame: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Individual participant dataSharing planned: No
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.
SEBAHAT ALTUNDAĞ contact
SEBAHAT ALTUNDAĞ principal investigator
Pamukkale University
Questions about this trial
What is this clinical trial studying?
A study testing Educational intervention in people with Clinical Comfort and Worry and Readiness Levels for Clinical Practice, run by Pamukkale University.
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: opening soon, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact HAMİDE COŞKUN ERÇELİK (+90 555 8478576, hamide_coskun_88@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Students' Readiness Levels for Clinical Practice (time frame: [Time Frame: one day in the first week of clinical practice] [Time Frame: one day in the third week of clinical practice] [Time Frame: one day in the last week (seventh) of clinical practice]). 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 19 Feb 2026.