- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05915624
Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery
The Effect of Pre-Surgery Tele Nursing Counseling on Anxiety and Patient Satisfaction in Same Day Surgery
The study was planned to be conducted as a randomized controlled experimental study to examine the effect of preoperative tele-nursing counseling on anxiety and patient satisfaction in same day surgery.
The main Research Hypotheses are; Preoperative tele-nursing counseling has no effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has an effect on anxiety in same day surgery.
Preoperative tele-nursing counseling has no effect on patient satisfaction in same day surgery.
Preoperative tele-nursing counseling has an effect on patient satisfaction in same day surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Power analysis was performed using the G*Power (v3.1.7) program to determine the number of samples. The power of the study (α) was accepted as 0.05 (95% confidence level), Type 2 error probability (β) was accepted as 0.20 (80% power level) and the effect size of 0.46 in the relevant literature (Pehlivan, 2021) was taken into account, and the minimum required minimum in the groups was taken into account. It was found that taking the sample size as 74 would be sufficient. In the study, it was aimed to have a total of 148 participants, 74 for the control group and 74 for the experimental group. Considering the possible loss, the study was completed with a total of 160 patients, 80 of which were in the control group and 80 in the experimental group.
While evaluating the findings obtained in the study, SPSS (Statistical Package for the Social Sciences) version 25.0 (IBM Corp., Armonk, NY, USA) program will be used for statistical analysis.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Şişli
-
İstanbul, Şişli, Turkey
- Ezgi Seyhan Ak
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Above 18 years old,
- Agreeing to participate in the research,
- Persons who will undergo day surgery in the field of general surgery, urology, orthopedic surgery, plastic surgery, neurosurgery,
- GKS score of 15,
- Not addicted to alcohol
- No psychiatric problems,
- Not using antipsychotic, antidepressant and anxiolytic drugs
- According to the ASA (American Society of Anesthesiologists) classification, ASA 1-2-3 -classification
- Speech and hearing impaired
- It is planned to include patients who have an open phone in the study.
Exclusion Criteria:
- Preoperative hospitalization
- Patients undergoing emergency surgery
- Patients who want to leave the study at any stage of the study
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: telephone counseling group
After signing the voluntary informed consent form, the patients in the experimental group were given a Preoperative Patient Information Brochure, prepared by the researcher when they came to the hospital for the surgery date.
Data will be collected using the Introductory Information Form and the Surgery-Specific Anxiety Scale, and counseling was provided by tele-nursing information about the surgery process one day before the surgery.
|
One day before the operation, information was given about the operation process via tele-nursing and counseling was provided.
|
|
No Intervention: Control group
The patients in the control group were given a Preoperative Patient Information Brochure, which was prepared by the researcher on the day of the surgery, when they came to the hospital for the surgery date after signing the voluntary informed consent form.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Surgery-Specific Anxiety Scale
Time Frame: two hours before going to surgery
|
It is a 5-point Likert-type scale.
(1-Strongly disagree, 2-Disagree, 3-Undecided, 4-Agree, 5-Completely agree).
The maximum score to be taken from the scale is 50.
In the scale scoring system, the emotions experienced by the patients were collected in 3 different dimensions.
|
two hours before going to surgery
|
|
Patient's Perception of Nursing Care Scale
Time Frame: two hours before discharge
|
It was used to measure the satisfaction level of patients with nursing care.
It is required to mark one of the 15 statements that make up the scale: Agree-5, Agree a little-4, Undecided-3, Disagree-2, Strongly Disagree-1 and No response-0.
The score given for each item is taken as a basis.
Thus, a minimum of 15 and a maximum of 75 points can be obtained from the scale.
The cut-off point of the scale is 45.
Scores above the cut-off point indicate a positive attitude.
|
two hours before discharge
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- IUCESEYHANAK001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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