- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07618949
Standardized Patient Education in Pituitary Surgery
The Impact of Standardized Patient Education on Patient Outcomes in Transsphenoidal Pituitary Surgery
Protocols are being developed and implemented to ensure the best possible recovery process for patients undergoing transsphenoidal surgery, and their impact on patient outcomes is being evaluated. In studies where perioperative protocols-including patient education (verbal and written instruction on dehydration, hyponatremia, adrenal insufficiency, CSF leakage, meningitis, and the signs and symptoms of visual or other neurological disorders)-are implemented, it has been reported that patients' length of hospital stay is reduced, the rate of patients experiencing hyponatremia has decreased, and readmissions have declined (Sanchez-Garavito et al., 2024; Sarris et al., 2021). However, since these studies included protocols covering the entire surgical process-not just patient education-it is difficult to determine whether changes in patient outcomes stem from patient education or from alterations in other parameters within the protocol.
Therefore, in the clinic where this study will be conducted, the effect of patient education on postoperative patient outcomes will be examined by developing an educational material that standardizes patient education, without making any changes to the surgical or pharmacological processes.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AKİF BULUT, PhD
- Phone Number: +905468722872
- Email: akifblt23@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Admitted for elective surgery due to a pituitary tumor.
- Has not previously undergone surgery for the same medical condition.
- Has voluntarily agreed to participate in the study.
- Has no missing medical data.
- Can speak Turkish or understand what is being explained.
- Patients aged 18 and older.
Exclusion Criteria:
- Emergency surgery will be performed.
- Revision surgery will be performed.
- Those who voluntarily decline to participate in the study.
- Those with incomplete medical data.
- Those who cannot speak or understand Turkish.
- Patients under the age of 18.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Education group
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery.
The educational material and the sources used to create it are included in the appendix.
Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material.
Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver.
Additionally, the material will be posted in a clearly visible location in the patient's room.
|
The standardized educational material to be used with the training group was developed by the researchers through a literature review and includes evidence-based recommendations that patients should follow after pituitary surgery.
The educational material and the sources used to create it are included in the appendix.
Before providing education to patients in the intervention group, nurses and resident physicians working in neurosurgery will receive in-person training on the rationale and details of the material.
Patients will be included in the education program starting from their preoperative hospital admission; the content of the educational material will be explained by a nurse, and a visual copy will be provided to both the patient and their caregiver.
Additionally, the material will be posted in a clearly visible location in the patient's room.
|
|
No Intervention: Control group
The control group for this study will consist of former patients who underwent pituitary surgery at the Neurosurgery Clinic prior to the start of this scientific study.
Routine post-operative care at the clinic following pituitary surgery is as follows: patients who have undergone pituitary surgery are provided with information about the surgical process by the attending physician prior to surgery, and their voluntary written consent is obtained.
After surgery, the physician, resident, and nurse provide verbal instructions to the patient regarding constipation and precautions related to the nose; however, no standardized written educational materials are used.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The total time from admission to discharge for patients who received standardized patient education in transsphenoidal pituitary surgery
Time Frame: "From the registration phase through to the end of the 52-week training program"
|
"From the registration phase through to the end of the 52-week training program"
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Complication rates (meningitis, hyponatremia, CSF leak) and rates of unplanned readmission among patients who received standardized training in transsphenoidal pituitary surgery during their hospital stay.
Time Frame: From the registration phase through to the end of the 52-week training program
|
From the registration phase through to the end of the 52-week training program
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Endocrine Gland Neoplasms
- Nervous System Neoplasms
- Central Nervous System Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Pituitary Diseases
- Pituitary Neoplasms
Other Study ID Numbers
- 2026-8/11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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