The Effect of Operating Room Nurse Visit Prior to Cardiac Surgery on Patients's Anxiety, Pain and Analgesic Use

NCT04525963 | Unknown

• 1 other identifier: NArpag
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Postoperative Anxiety; Pain; Postoperative Pain Management

Keywords

Anxiety; Surgical anxiety; Surgical pain; Open heart surgey; Nursing

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

Study Arms (2)

Experimental: Intervention Arm

EXPERIMENTAL

: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.

Other: Preoperative visit of the operating room nurse and patient education

No Intervention

NO INTERVENTION

There will be no intervention in the control group. The procedures of the institution will be applied before and after the operation.

Interventions

Preoperative visit of the operating room nurse and patient education OTHER

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.

Experimental: Intervention Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between the ages of 18-75,
• Having surgery with a cardiopulmonary bypass (CPB)
• no psychiatric diagnosis and drug use
• first cardiovascular experience
• having elective and planned surgery
• being literate and speaking Turkish
• Patients who agree to participate in the study will be included in the study.

You may not qualify if:

• Emergency surgery,
• Being under the age of 18
• psychiatric diagnosis and drug use
• Not using cardiopulmonary bypass
• have previously had open heart surgery
• be illiterate
• not understanding and speaking Turkish
• staying in intensive care for more than 96 hours or returning to intensive care
• refuse to participate in the study

Sponsors & Collaborators

• Nurgül Arpag: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Denyan Mansuroğlu, Prof.

  Istanbul Yeni Yüzyıl University GOP Hospital

  PRINCIPAL INVESTIGATOR

• Deniz S Öztekin, Prof.

  Istanbul University - Cerrahpasa

  STUDY DIRECTOR

• Nurgül Arpag, MSC

  Istanbul University - Cerrahpasa

  STUDY CHAIR

Central Study Contacts

Nurgül Arpag, MSC

CONTACT

+905326319262; nurgul.deveci@ogr.iu.edu.tr

Deniz S Öztekin, Prof.

CONTACT

+905322705559; oztekin.deniz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer

Model Details: A quasi-experimental pre-test post-test control group design in non-randomized groups study,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

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 25, 2020
• Study Start: February 20, 2021
• Primary Completion: April 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share