Cognitive Behavioral NursingNCT05943184
Cognitive Behavioral Nursing Model
A study testing Cognitive Behavioral Nursing Model in people with Cognitive Behavioral Nursing and Congenital Glaucoma, run by Taiyuan Central Hospital of Shanxi Medical University at 1 site in China.
Trial summary
Materials and Methods 1. General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cognitive Behavioral Nursing, Congenital Glaucoma
- What is being tested?
- Cognitive Behavioral Nursing Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- meeting the diagnostic criteria for glaucoma;
- following the attending doctor's recommendations to receive surgical treatment, and;
- volunteering to participate in the study
Who cannot join
- severe organic dysfunction;
- cardiovascular and/or cerebrovascular diseases;
- hypertension;
- contraindications for surgery;
- other eye diseases;
- communication disorders;
- mental illnesses
Trial locations and contacts
1 site in 1 country.
China1 site
Taiyuan Central hospital of Shanxi Medical University
Taiyuan, Shanxi, 030009
About this study
Official title: Clinical Value of Cognitive Behavioral Nursing Model to Patients With Congenital Glaucoma
Materials and Methods
- General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. The inclusion criteria were as follows: (1) meeting the diagnostic criteria for glaucoma, (2) following the attending doctor's recommendations to receive surgical treatment, and (3) volunteering to participate in the study. The exclusion criteria were as follows: (1) severe organic dysfunction, (2) cardiovascular and/or cerebrovascular diseases, (3) hypertension, (4) contraindications for surgery, (5) other eye diseases, (6) communication disorders, and (7) mental illnesses. Informed consent with signature was obtained from every participant, and the study has been approved by the hospital's ethics committee.
- Research methods The control group was provided with routine care, including warm reception and provision of a quiet, clean, and well-ventilated ward environment for good rest. Patients were educated to broaden their knowledge of the disease and related surgical treatment, particularly the importance and outcomes of surgical treatment, thereby allaying their feeling of fear and boosting their confidence in recovery. Meanwhile, patients were encouraged to break their unhealthy habits, avoid bad diet choices, and take medications on time. The observation group received CBNI described as follows: (1) A cognitive-behavioral intervention group was set up by several nurses who had a background of systematic cognitive intervention training, were able to independently develop comprehensive behavioral intervention plans and assess a patient's cognitive level, and had an adequate understanding of the fundamentals of cognitive behavioral intervention. Through thorough communication with patients, these nurses were supposed to identify their major concerns and assess their cognitive behavior. Based on the assessment results, psychological counseling was provided for every patient, with each session lasting at least 50 minutes. In addition, the nurses were required to reassure all patients by proactively introducing the precautions of surgery and nursing care. (2) Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. Professional education was provided through communication with patients so that they could gain detailed knowledge of the disease. Chatting and music were useful to relieve tension and psychological stress. Regular patient support groups were organized to help patients develop confidence and a positive attitude toward the disease. (3) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. The nurses were also required to closely monitor patient compliance from the perspectives of diet, lifestyle, psychology, and treatment. (4) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. It should be noted that smooth bowel movements are essential to prevent increased IOP induced by constipation. Therefore, the recommended diet is high in dietary fiber and fruits. (5) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans. The nurses were responsible for guiding the proper use of eye drops by patients, reminding all patients to seek medical attention immediately if they experienced any eye discomfort, and stressing the risk of increasing IOP due to prolonged periods of looking down and other unhealthy habits.
- Statistical analysis The software SPSS22.0 was used for data analysis. Measurement data were expressed as "mean ± standard deviation (x±s)", and comparisons between the two groups were examined by the t-test. Enumeration data were represented as percentages (%) and inter-group comparisons were examined using the χ2 test. Significance was set at the level of P <0.05.
- Conditions
- Cognitive Behavioral Nursing, Congenital Glaucoma
- Being tested
- Cognitive Behavioral Nursing Model
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Nursing ModelBehavioural
(1)Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. (2) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. (3) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. (4) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| Observation group | Experimental | Not described Receives: Behavioral: Cognitive Behavioral Nursing Model |
What is being measured
The primary outcome is the main question the study is designed to answer.
SDS scores
The cutoff score for SAS is 50, with scores of 50-59 indicative of mild anxiety, 60-69 of moderate anxiety, and scores above 70 of severe anxiety.
Measured: before and at one month of nursing intervention
SAS scores
The cutoff score for SDS is 53, with scores of 53-62 standing for mild depression, 63-72 for moderate depression, and scores above 72 for severe depression.
Measured: before and at one month of nursing intervention
Psychological resilience
The level of psychological resilience was evaluated using the Connor-Davidson Resilience Scale, which covers three dimensions: optimism, self-efficacy, and resilience, with the total score ranging from 0 to 100, and higher scores reflecting greater resilience.
Measured: Baseline (Before the intervention)
Patient compliance
The level of patient compliance during the perioperative period was assessed using an evaluation form that describes the level of compliance as complete compliance (compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), partial compliance (occasional compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), or noncompliance (failure to meet any of the above-mentioned criteria). The compliance rate (%) was calculated as (complete compliance + partial compliance) / total cases × 100%.
Measured: Immediately after nursing
Visual acuity (VA)
a higher VA value indicates better treatment outcomes
Measured: At 2 weeks of nursing intervention
IOP
a lower IOP values indicates better treatment outcomes
Measured: At 2 weeks of nursing intervention
mean deviation (MD)
a lower MD values indicates better treatment outcomes
Measured: At 2 weeks of nursing intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Jan 2021
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Behavioral NursingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiyuan Central Hospital of Shanxi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanfang Ma, Taiyuan Central Hospital of Shanxi Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943184
- Sponsor's protocol ID
- TaiyuanCH 001
- Status last verified
- Apr 2024
- First submitted
- 14 Jun 2023
- Last updated
- 24 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Value of Cognitive Behavioral Nursing Model to Patients With Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT05943184
- Acronym / sponsor ID
- TaiyuanCH 001
- Conditions
- Cognitive Behavioral Nursing, Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Taiyuan Central Hospital of Shanxi Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 13 Jul 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.
Materials and Methods
- General information This study enrolled 153 patients with congenital glaucoma who were treated at our hospital from January 2021 to December 2022. These patients were divided into an observation group (n = 76) and a control group (n = 77) using a random number table. The inclusion criteria were as follows: (1) meeting the diagnostic criteria for glaucoma, (2) following the attending doctor's recommendations to receive surgical treatment, and (3) volunteering to participate in the study. The exclusion criteria were as follows: (1) severe organic dysfunction, (2) cardiovascular and/or cerebrovascular diseases, (3) hypertension, (4) contraindications for surgery, (5) other eye diseases, (6) communication disorders, and (7) mental illnesses. Informed consent with signature was obtained from every participant, and the study has been approved by the hospital's ethics committee.
- Research methods The control group was provided with routine care, including warm reception and provision of a quiet, clean, and well-ventilated ward environment for good rest. Patients were educated to broaden their knowledge of the disease and related surgical treatment, particularly the importance and outcomes of surgical treatment, thereby allaying their feeling of fear and boosting their confidence in recovery. Meanwhile, patients were encouraged to break their unhealthy habits, avoid bad diet choices, and take medications on time. The observation group received CBNI described as follows: (1) A cognitive-behavioral intervention group was set up by several nurses who had a background of systematic cognitive intervention training, were able to independently develop comprehensive behavioral intervention plans and assess a patient's cognitive level, and had an adequate understanding of the fundamentals of cognitive behavioral intervention. Through thorough communication with patients, these nurses were supposed to identify their major concerns and assess their cognitive behavior. Based on the assessment results, psychological counseling was provided for every patient, with each session lasting at least 50 minutes. In addition, the nurses were required to reassure all patients by proactively introducing the precautions of surgery and nursing care. (2) Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. Professional education was provided through communication with patients so that they could gain detailed knowledge of the disease. Chatting and music were useful to relieve tension and psychological stress. Regular patient support groups were organized to help patients develop confidence and a positive attitude toward the disease. (3) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. The nurses were also required to closely monitor patient compliance from the perspectives of diet, lifestyle, psychology, and treatment. (4) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. It should be noted that smooth bowel movements are essential to prevent increased IOP induced by constipation. Therefore, the recommended diet is high in dietary fiber and fruits. (5) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans. The nurses were responsible for guiding the proper use of eye drops by patients, reminding all patients to seek medical attention immediately if they experienced any eye discomfort, and stressing the risk of increasing IOP due to prolonged periods of looking down and other unhealthy habits.
- Statistical analysis The software SPSS22.0 was used for data analysis. Measurement data were expressed as "mean ± standard deviation (x±s)", and comparisons between the two groups were examined by the t-test. Enumeration data were represented as percentages (%) and inter-group comparisons were examined using the χ2 test. Significance was set at the level of P <0.05.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| Observation group | Experimental | Behavioral: Cognitive Behavioral Nursing Model |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- meeting the diagnostic criteria for glaucoma;
- following the attending doctor's recommendations to receive surgical treatment, and;
- volunteering to participate in the study
Key exclusion criteria (7 listed)
- severe organic dysfunction;
- cardiovascular and/or cerebrovascular diseases;
- hypertension;
- contraindications for surgery;
- other eye diseases;
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 |
|---|---|---|
| Cognitive Behavioral Nursing Model(1)Psychological intervention was accessible to those who felt resistant to their treatment plans or developed inferior feelings due to visual impairment to establish a good relationship with patients and help them better cope with unhealthy emotions. (2) Health education was provided through self-developed booklets and question-and-answer sessions to publicize the fundamental knowledge and make sure all patients have a full understanding of the disease and related treatments. (3) Dietary guidelines were set out to encourage a light, healthy diet with fruits and vegetables, free of irritating food, and containing a limited amount of oily food. (4) Behavioral guidelines were developed to address the importance of quitting tobacco use and prevent eye strain due to excessive eye use with tailored eye care plans. | Behavioural | Observation group |
Primary outcome
SDS scores
Time frame: before and at one month of nursing intervention
The cutoff score for SAS is 50, with scores of 50-59 indicative of mild anxiety, 60-69 of moderate anxiety, and scores above 70 of severe anxiety.
SAS scores
Time frame: before and at one month of nursing intervention
The cutoff score for SDS is 53, with scores of 53-62 standing for mild depression, 63-72 for moderate depression, and scores above 72 for severe depression.
Psychological resilience
Time frame: Baseline (Before the intervention)
The level of psychological resilience was evaluated using the Connor-Davidson Resilience Scale, which covers three dimensions: optimism, self-efficacy, and resilience, with the total score ranging from 0 to 100, and higher scores reflecting greater resilience.
Patient compliance
Time frame: Immediately after nursing
The level of patient compliance during the perioperative period was assessed using an evaluation form that describes the level of compliance as complete compliance (compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), partial compliance (occasional compliance with all medical orders, surgical procedures, dietary guidelines, and schedule), or noncompliance (failure to meet any of the above-mentioned criteria). The compliance rate (%) was calculated as (complete compliance + partial compliance) / total cases × 100%.
Visual acuity (VA)
Time frame: At 2 weeks of nursing intervention
a higher VA value indicates better treatment outcomes
IOP
Time frame: At 2 weeks of nursing intervention
a lower IOP values indicates better treatment outcomes
mean deviation (MD)
Time frame: At 2 weeks of nursing intervention
a lower MD values indicates better treatment outcomes
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 24 Apr 2024.
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 Cognitive Behavioral Nursing Model in people with Cognitive Behavioral Nursing and Congenital Glaucoma, run by Taiyuan Central Hospital of Shanxi Medical University at 1 site in China.
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 7 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 24 Apr 2024. 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 China. 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?
SDS scores (time frame: before and at one month of nursing intervention). The study lists 7 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 24 Apr 2024; AzTrials last refreshed its copy on 26 Oct 2026.