Sponsor study identifier
interventional
64
0 countries
N/A
Study Start
February 20, 2021
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Primary Completion
April 1, 2021
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Study Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study was planned as a quasi-experimental pre-test post-test control group design in non-randomized groups to determine the effect of the preoperative visit by the operating room nurse on the postoperative anxiety level and pain severity of patients undergoing open heart surgery.After approval of the ethics committee and institutional permission, 64 patients who were operated in Cardiovascular Surgery between September 1, 2020 and April 1, 2020 and met the inclusion criteria will be included in the study.Sample size and power analysis of the research was calculated by using the Clinical Calculator program,reported academic studies was determined as effect value (size) d = 2.0935, α = 0.05 (margin of error), 1-β = 0.80 (Power).It was decided to include 64 people (32 per group). operated with the CPB (cardiopulmonary bypass) method were included. The assignment to the control group and the experimental group of patients who meet the inclusion criteria and agree to participate in the study will be made with the random numbers table created using the create number function in the Excel program.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 1, 2021
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2020
Actual (reported)August 25, 2020
Actual (reported)February 20, 2021
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April 1, 2021
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September 1, 2021
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1. Anxiety before and after surgery / State Trait Anxiety Scale I-II' Score
Anxiety severity will be assessment with 'State Trait Anxiety Scale I-II' State anxiety scale-I,it involves the marking of (1) none, (2) a little, (3) quite, (4) completely one of the options of the individual at a given moment according to the current emotions of the items of the scale. The trait anxiety scale-II, requires one out of four options to mark how the individual usually feels (1) almost never, (2) sometimes, (3) much time, (4) almost always. There are two types of expressions in the scales, are called direct or inverted expressions. Direct expressions, negative emotions; reversed expressions express positive feelings.
In the preoperative period, the anxiety scale score will be evaluated within the last 18 hours. In the postoperative period, the anxiety scale score will be evaluated within the first 18 hours.
2. Postoperative pain severity
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
In the postoperative period, the severity of the pain is evaluated until the end of the first 24 hours.
:In the experimental group,the operating room nurse, who is given intervention training , will be provided to visit the patient before surgery. After the verbal training of the operating room nurse, a printed booklet will be left for the patient to read. Assigned Interventions The level of anxiety experienced by the patients increases the postoperative perception and analgesic need, increasing the sequence and anesthetic substance. For these reasons, there is a need for studies to reduce pain distribution and severity by directly dealing with pre- and postoperative anxiety and anxiety levels. Similarly, the role of the operating room nurse in reducing patient anxiety is increasingly recognized. It is observed that the pre-operative visit and education reduce the pre-operative anxiety level in patients undergoing surgical intervention, and the pre-operative visit of the operating room nurse is on the agenda.
There will be no intervention in the control group. The procedures of the institution will be applied before and after the operation.
The operating room nurse, who is given intervention training, will visit the patient before the operation. After the oral training of the operating room nurse, a printed booklet will be left for the patient to read.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Denyan Mansuroğlu, Prof.
Istanbul Yeni Yüzyıl University GOP Hospital
Deniz S Öztekin, Prof.
Istanbul University - Cerrahpasa
Nurgül Arpag, MSC
Istanbul University - Cerrahpasa
First Submitted
August 17, 2020
First Posted
August 25, 2020
Study Start
February 20, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
3. Measurement of postoperative analgesic use
Monitoring analgesic use:time, name, type, dose, frequency and route of administration will be tracked with the Analgesic Registration form.
The analgesics used in the postoperative period are evaluated until the end of the first 24 hours.
Contact the study team to confirm eligibility.
Primary Completion
April 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 1, 2021
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 20, 2021
Record last verified: 2021-01
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