Nursing CariesNCT05371769
Evaluation of the Efficiency of the Chronic Pain Management Training Program
A study testing chronic pain management education program in people with Nursing Caries and Chronic Pain, run by Çankırı Karatekin University at 1 site in Turkey (Türkiye).
Trial summary
The research will be conducted to evaluate the effectiveness of the web-based chronic pain management training program developed for nursing students. It is planned in a randomized controlled triple-blind design with the final year nursing students of the Nursing Department of Çankırı Karatekin University in a… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nursing Caries, Chronic Pain
- What is being tested?
- chronic pain management education program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 16 May 2022to 13 Jun 2022
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nursing Grade 4
- with internet access
- Students who volunteered to participate in the research
Who cannot join
- Having a diagnosed psychiatric disorder
- Difficulty in understanding and speaking Turkish
- Graduated from Health Vocational High School
- Attending any training on pain and/or having a pain education certificate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Efficiency of the Chronic Pain Management Education Program Developed for Nursing Students
The research will be conducted to evaluate the effectiveness of the web-based chronic pain management training program developed for nursing students. It is planned in a randomized controlled triple-blind design with the final year nursing students of the Nursing Department of Çankırı Karatekin University in a pre-test-post-test order.
- Conditions
- Nursing Caries, Chronic Pain
- Being tested
- chronic pain management education program, No intervention
- Keywords
- Chronic pain, Nursing student education, Web-Technology based education
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chronic pain management education programOther
Also called Experimental group
The chronic pain management training program will be applied for 2 weeks. The training consists of 15 videos about theory and practice topics in chronic pain management. There are evaluation questions at the end of each video.
No interventionOther
Also called Control group
No intervention will be made.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Sham comparator | The students in the control group will be given a pre-test, and two weeks later, the post-test will be applied. After the chronic pain education group completes the research, the chronic pain education program will be opened to the students in the control group, too. Receives: Other: No intervention |
| Chronic pain education group | Experimental | The pre-test will be opened to the students in the chronic pain education group simultaneously with the opening of the post-tests for the control group.After the students in the chronic pain education group completed the pre-test, the chronic pain management training program developed for nursing students will be applied for 2 weeks. Post test will be applied at the end of all training videos and evaluation questions. Receives: Other: chronic pain management education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Introductory features form
It was prepared by the researcher in line with the literature knowledge. In the form of introductory characteristics of nursing students; There are 7 questions about the students' date of birth, gender, whether they have chronic pain, whether they have chronic pain from family members they live with, in which clinics they do internship, and whether they find themselves competent in the management of chronic pain of the patients they care for.
Measured: pre-intervention
Scale of attitudes of students studying in the field of health towards patients with chronic pain
The Attitude Scale of Health Students towards Patients with Chronic Pain is a 5-point Likert scale and has 18 items. It consists of two factors: sensitivity orientation and error orientation. The Cronbach's Alpha coefficients are 0.88 and 0.75 for the first and second factors, respectively. Each factor gets a separate score. Each item in the factors receives a score between "1" and "5". The scores are summed up and divided by the number of items, then a score between 1 and 5 is obtained, thus a standard evaluation of two factors can be done. There is no cut-off score in the scale.
An increased score from the sensitivity and misconception orientation factors indicates that healthcare professionals' attitude towards patients with chronic pain is positively strong. On the other hand, a low score on these factors indicates a strong negative attitude.
Measured: pre-intervention
Scale of attitudes of students studying in the field of health towards patients with chronic pain
The Attitude Scale of Health Students towards Patients with Chronic Pain is a 5-point Likert scale and has 18 items. It consists of two factors: sensitivity orientation and error orientation. The Cronbach's Alpha coefficients are 0.88 and 0.75 for the first and second factors, respectively. Each factor gets a separate score. Each item in the factors receives a score between "1" and "5". The scores are summed up and divided by the number of items, then a score between 1 and 5 is obtained, thus a standard evaluation of two factors can be done. There is no cut-off score in the scale.
An increased score from the sensitivity and misconception orientation factors indicates that healthcare professionals' attitude towards patients with chronic pain is positively strong. On the other hand, a low score on these factors indicates a strong negative attitude.
Measured: immediately after the intervention
Chronic pain management knowledge test
The knowledge test on chronic pain management was created by the researchers in line with the literature. The knowledge test for chronic pain management includes 24 case-based five-choice multiple-choice questions. In this test, each correct answer is 1 point and a wrong answer is zero. The total score is obtained by adding the scores obtained from the test. The highest score that can be obtained from the test is 24, and the lowest score is zero. An increase in the score obtained from the test indicates that the participant's level of knowledge about chronic pain management increases, while a decrease in the score indicates a low level of knowledge.
Measured: pre-intervention
Chronic pain management knowledge test
The knowledge test on chronic pain management was created by the researchers in line with the literature. The knowledge test for chronic pain management includes 24 case-based five-choice multiple-choice questions. In this test, each correct answer is 1 point and a wrong answer is zero. The total score is obtained by adding the scores obtained from the test. The highest score that can be obtained from the test is 24, and the lowest score is zero. An increase in the score obtained from the test indicates that the participant's level of knowledge about chronic pain management increases, while a decrease in the score indicates a low level of knowledge.
Measured: immediately after the intervention
Chronic pain management training program evaluation form
Chronic pain management training program evaluation Form, Game-based virtual reality application evaluation form in Bıyık-Bayram and Çalışkan's (2017) The Effects of Game-Based Virtual Reality Application on Nursing Students' Learning Tracheostomy Care, was revised and revised to the chronic pain management training program. has been prepared. This form consists of two parts. The first part consists of two open-ended questions about the positive and negative thoughts of the students about the chronic pain management education program, and the second part consists of 16 questions that include 5-point Likert-type scoring in which the statements about the education program are evaluated. Each item in the form receives a score between "1" and "5". An increase in the score obtained from the form indicates that the participant evaluated the chronic pain management training program p vely.This form will be filled by the students in the experimental group at the end of the post-test.
Measured: immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start16 May 2022
- Primary completion13 Jun 2022
- Study completion13 Jun 2022
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.
- 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
- Model description
- Randomization: After applying the exclusion criteria to a total of 94 students, the students who accepted to participate in the study was randomly selected into two groups (A and B) of 35 students by simple random sampling by creating a computer-assisted simple random numbers table (www.randomizer.org). Selected students was randomly assigned so that the general academic achievement grades of both groups were homogeneous. The groups was randomly assigned to the intervention or control group by the code "A" and "B" by the software specialist.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Çankırı Karatekin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nefise Cevriye SUCU ÇAKMAK, Çankırı Karatekin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371769
- Sponsor's protocol ID
- NSUCUCAKMAK
- Status last verified
- Jan 2023
- First submitted
- 27 Apr 2022
- Last updated
- 11 Jan 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 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficiency of the Chronic Pain Management Education Program Developed for Nursing Students
- ClinicalTrials.gov ID
- NCT05371769
- Acronym / sponsor ID
- NSUCUCAKMAK
- Conditions
- Nursing Caries, Chronic Pain
- Keywords
- Chronic pain, Nursing student education, Web-Technology based education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Çankırı Karatekin UniversityUniversity, hospital or other
- Study start
- 16 May 2022 (actual)
- Primary completion
- 13 Jun 2022 (actual)
- Study completion
- 13 Jun 2022 (actual)
- First posted
- 12 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 research will be conducted to evaluate the effectiveness of the web-based chronic pain management training program developed for nursing students. It is planned in a randomized controlled triple-blind design with the final year nursing students of the Nursing Department of Çankırı Karatekin University in a pre-test-post-test order.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomization: After applying the exclusion criteria to a total of 94 students, the students who accepted to participate in the study was randomly selected into two groups (A and B) of 35 students by simple random sampling by creating a computer-assisted simple random numbers table (www.randomizer.org). Selected students was randomly assigned so that the general academic achievement grades of both groups were homogeneous. The groups was randomly assigned to the intervention or control group by the code "A" and "B" by the software specialist.
| Arm | Type | Receives |
|---|---|---|
| Control group | Sham comparator | Other: No interventionThe students in the control group will be given a pre-test, and two weeks later, the post-test will be applied. After the chronic pain education group completes the research, the chronic pain education program will be opened to the students in the control group, too. |
| Chronic pain education group | Experimental | Other: chronic pain management education programThe pre-test will be opened to the students in the chronic pain education group simultaneously with the opening of the post-tests for the control group.After the students in the chronic pain education group completed the pre-test, the chronic pain management training program developed for nursing students will be applied for 2 weeks. Post test will be applied at the end of all training videos and evaluation questions. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Nursing Grade 4
- with internet access
- Students who volunteered to participate in the research
Key exclusion criteria (4 listed)
- Having a diagnosed psychiatric disorder
- Difficulty in understanding and speaking Turkish
- Graduated from Health Vocational High School
- Attending any training on pain and/or having a pain education certificate
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 |
|---|---|---|
| chronic pain management education programAlso: Experimental groupThe chronic pain management training program will be applied for 2 weeks. The training consists of 15 videos about theory and practice topics in chronic pain management. There are evaluation questions at the end of each video. | Other | Chronic pain education group |
| No interventionAlso: Control groupNo intervention will be made. | Other | Control group |
Primary outcome
Introductory features form
Time frame: pre-intervention
It was prepared by the researcher in line with the literature knowledge. In the form of introductory characteristics of nursing students; There are 7 questions about the students' date of birth, gender, whether they have chronic pain, whether they have chronic pain from family members they live with, in which clinics they do internship, and whether they find themselves competent in the management of chronic pain of the patients they care for.
Scale of attitudes of students studying in the field of health towards patients with chronic pain
Time frame: pre-intervention
The Attitude Scale of Health Students towards Patients with Chronic Pain is a 5-point Likert scale and has 18 items. It consists of two factors: sensitivity orientation and error orientation. The Cronbach's Alpha coefficients are 0.88 and 0.75 for the first and second factors, respectively. Each factor gets a separate score. Each item in the factors receives a score between "1" and "5". The scores are summed up and divided by the number of items, then a score between 1 and 5 is obtained, thus a standard evaluation of two factors can be done. There is no cut-off score in the scale. An increased score from the sensitivity and misconception orientation factors indicates that healthcare professionals' attitude towards patients with chronic pain is positively strong. On the other hand, a low score on these factors indicates a strong negative attitude.
Scale of attitudes of students studying in the field of health towards patients with chronic pain
Time frame: immediately after the intervention
The Attitude Scale of Health Students towards Patients with Chronic Pain is a 5-point Likert scale and has 18 items. It consists of two factors: sensitivity orientation and error orientation. The Cronbach's Alpha coefficients are 0.88 and 0.75 for the first and second factors, respectively. Each factor gets a separate score. Each item in the factors receives a score between "1" and "5". The scores are summed up and divided by the number of items, then a score between 1 and 5 is obtained, thus a standard evaluation of two factors can be done. There is no cut-off score in the scale. An increased score from the sensitivity and misconception orientation factors indicates that healthcare professionals' attitude towards patients with chronic pain is positively strong. On the other hand, a low score on these factors indicates a strong negative attitude.
Chronic pain management knowledge test
Time frame: pre-intervention
The knowledge test on chronic pain management was created by the researchers in line with the literature. The knowledge test for chronic pain management includes 24 case-based five-choice multiple-choice questions. In this test, each correct answer is 1 point and a wrong answer is zero. The total score is obtained by adding the scores obtained from the test. The highest score that can be obtained from the test is 24, and the lowest score is zero. An increase in the score obtained from the test indicates that the participant's level of knowledge about chronic pain management increases, while a decrease in the score indicates a low level of knowledge.
Chronic pain management knowledge test
Time frame: immediately after the intervention
The knowledge test on chronic pain management was created by the researchers in line with the literature. The knowledge test for chronic pain management includes 24 case-based five-choice multiple-choice questions. In this test, each correct answer is 1 point and a wrong answer is zero. The total score is obtained by adding the scores obtained from the test. The highest score that can be obtained from the test is 24, and the lowest score is zero. An increase in the score obtained from the test indicates that the participant's level of knowledge about chronic pain management increases, while a decrease in the score indicates a low level of knowledge.
Chronic pain management training program evaluation form
Time frame: immediately after the intervention
Chronic pain management training program evaluation Form, Game-based virtual reality application evaluation form in Bıyık-Bayram and Çalışkan's (2017) The Effects of Game-Based Virtual Reality Application on Nursing Students' Learning Tracheostomy Care, was revised and revised to the chronic pain management training program. has been prepared. This form consists of two parts. The first part consists of two open-ended questions about the positive and negative thoughts of the students about the chronic pain management education program, and the second part consists of 16 questions that include 5-point Likert-type scoring in which the statements about the education program are evaluated. Each item in the form receives a score between "1" and "5". An increase in the score obtained from the form indicates that the participant evaluated the chronic pain management training program p vely.This form will be filled by the students in the experimental group at the end of the post-test.
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 11 Jan 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 chronic pain management education program in people with Nursing Caries and Chronic Pain, run by Çankırı Karatekin 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 3 inclusion and 4 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 11 Jan 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. Some participants in this study may receive a placebo. 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?
Introductory features form (time frame: pre-intervention). The study lists 6 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 11 Jan 2023.