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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05915624
Other study ID # IUCESEYHANAK001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2022
Est. completion date May 30, 2023

Study information

Verified date June 2023
Source Istanbul University - Cerrahpasa (IUC)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date May 30, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
telephone counseiling
One day before the operation, information was given about the operation process via tele-nursing and counseling was provided.

Locations

Country Name City State
Turkey Ezgi Seyhan Ak Istanbul Sisli

Sponsors (2)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC) Assoc.Prof.Ezgi Seyhan Ak

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgery-Specific Anxiety Scale 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
Primary Patient's Perception of Nursing Care Scale 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
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