Postoperative AnxietyNCT04525963
The Effect of Operating Room Nurse Visit Prior to Cardiac Surgery on Patients's Anxiety, Pain and Analgesic Use
A study testing Preoperative visit of the operating room nurse and patient education in people with Postoperative Anxiety and Pain, run by Nurgül Arpag.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Anxiety, Pain, Postoperative Pain Management
- What is being tested?
- Preoperative visit of the operating room nurse and patient education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 20 Feb 2021to 1 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Patients who will undergo cardiac surgery between 01 September 2020 and 01 April 2021 and meet the inclusion criteria will be able to participate in the study with their verbal and written consents. The assignment of the patients to the control or experimental group will be done with the random numbers table created using the generate number function in the Excel program. This study will be conducted in 64 patients (32 patients in each group) who will be operated in cardiac surgery at Istanbul Yeni Yüzyıl University GOP hospital. In order to determine the postoperative anxiety and pain management effects of the patient visit of the operating room nurse, the pre-test-post-test control group design will be made quasi-experimental in non-randomized groups. The variables of the study were anxiety, pain, and analgesic use. As data collection tools, 'Sampling Criteria Form' will be used for sampling and 'State Trait Anxiety Scale I-II ' will be used for anxiety assessment. "VAS (Visual Analogue Scale)" will be used for pain assessment, and "Analgesic Follow-up Form" developed by the researcher will be used for the recording of analgesics. The "Data Recording Form" created by the researcher will be used to record the demographic and medical data of the patients.
The researcher will apply the "State-Trait Anxiety Scale" to determine the level of anxiety after visiting the patient's room and obtaining verbal and written permission from the patient. If the patient is in the control group, it will be ensured that the institutional procedures are implemented and followed without any intervention (without visiting and verbal training printed booklet). 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. It will be ensured that the nurse visiting the patient in her room will be welcomed in the operating room. After the operation, the pain level of the patient will be monitored by the Visual Assessment Scale (VAS) in the intensive care and inpatient floor. Pain level and use of analgesics will be monitored at the first 72 hours and thereafter until the thoracic tubes are removed. The analgesics ordered for the patient will be recorded according to time, name, dose and route of administration. For these records, "Analgesic Registration Form" developed by the researcher will be used.Patients with prolonged intensive care stay (over 96 hours) and returning to intensive care will be excluded from the evaluation. If these patients are excluded from the study, an "intention to treat" (ITT) analysis will be performed to assess the realistic effect of the intervention. "State-Trait Anxiety Scale" will be applied again by the researcher on the 24th hour to determine the postoperative anxiety level of all patients.
- Conditions
- Postoperative Anxiety, Pain, Postoperative Pain Management
- Being tested
- Preoperative visit of the operating room nurse and patient education
- Keywords
- Anxiety, Surgical anxiety, Surgical pain, Open heart surgey, Nursing
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative visit of the operating room nurse and patient educationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: The analgesics used in the postoperative period are evaluated until the end of the first 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2020
- Study start20 Feb 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Sep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nurgül Arpag
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nurgül Arpag, Istanbul University - Cerrahpasa
- Investigators
- Denyan Mansuroğlu, Prof., Principal investigator, Istanbul Yeni Yüzyıl University GOP HospitalDeniz S Öztekin, Prof., Study director, Istanbul University - CerrahpasaNurgül Arpag, MSC, Study chair, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525963
- Sponsor's protocol ID
- NArpag
- Status last verified
- Jan 2021
- First submitted
- 17 Aug 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Operating Room Nurse Visit Prior to Cardiac Surgery on Patients's Anxiety, Pain and Analgesic Use
- ClinicalTrials.gov ID
- NCT04525963
- Acronym / sponsor ID
- NArpag
- Conditions
- Postoperative Anxiety, Pain, Postoperative Pain Management
- Keywords
- Anxiety, Surgical anxiety, Surgical pain, Open heart surgey, Nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Nurgül ArpagUniversity, hospital or other
- Study start
- 20 Feb 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Sep 2021 (estimated)
- First posted
- 25 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients who will undergo cardiac surgery between 01 September 2020 and 01 April 2021 and meet the inclusion criteria will be able to participate in the study with their verbal and written consents. The assignment of the patients to the control or experimental group will be done with the random numbers table created using the generate number function in the Excel program. This study will be conducted in 64 patients (32 patients in each group) who will be operated in cardiac surgery at Istanbul Yeni Yüzyıl University GOP hospital. In order to determine the postoperative anxiety and pain management effects of the patient visit of the operating room nurse, the pre-test-post-test control group design will be made quasi-experimental in non-randomized groups. The variables of the study were anxiety, pain, and analgesic use. As data collection tools, 'Sampling Criteria Form' will be used for sampling and 'State Trait Anxiety Scale I-II ' will be used for anxiety assessment. "VAS (Visual Analogue Scale)" will be used for pain assessment, and "Analgesic Follow-up Form" developed by the researcher will be used for the recording of analgesics. The "Data Recording Form" created by the researcher will be used to record the demographic and medical data of the patients.
The researcher will apply the "State-Trait Anxiety Scale" to determine the level of anxiety after visiting the patient's room and obtaining verbal and written permission from the patient. If the patient is in the control group, it will be ensured that the institutional procedures are implemented and followed without any intervention (without visiting and verbal training printed booklet). 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. It will be ensured that the nurse visiting the patient in her room will be welcomed in the operating room. After the operation, the pain level of the patient will be monitored by the Visual Assessment Scale (VAS) in the intensive care and inpatient floor. Pain level and use of analgesics will be monitored at the first 72 hours and thereafter until the thoracic tubes are removed. The analgesics ordered for the patient will be recorded according to time, name, dose and route of administration. For these records, "Analgesic Registration Form" developed by the researcher will be used.Patients with prolonged intensive care stay (over 96 hours) and returning to intensive care will be excluded from the evaluation. If these patients are excluded from the study, an "intention to treat" (ITT) analysis will be performed to assess the realistic effect of the intervention. "State-Trait Anxiety Scale" will be applied again by the researcher on the 24th hour to determine the postoperative anxiety level of all patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental: Intervention Arm | Experimental | Other: Preoperative visit of the operating room nurse and patient education: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. |
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- Emergency surgery,
- Being under the age of 18
- psychiatric diagnosis and drug use
- Not using cardiopulmonary bypass
- have previously had open heart surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative visit of the operating room nurse and patient educationThe 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. | Other | Experimental: Intervention Arm |
Primary outcome
1. Anxiety before and after surgery / State Trait Anxiety Scale I-II' Score
Time frame: 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.
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.
2. Postoperative pain severity
Time frame: In the postoperative period, the severity of the pain is evaluated until the end of the first 24 hours.
Pain severity assessment with Visual Assessment Scale (VAS) Score: 0-10; 0- No Pain, 10- Worst pain
3. Measurement of postoperative analgesic use
Time frame: The analgesics used in the postoperative period are evaluated until the end of the first 24 hours.
Monitoring analgesic use:time, name, type, dose, frequency and route of administration will be tracked with the Analgesic Registration form.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denyan Mansuroğlu, Prof. principal investigator
Istanbul Yeni Yüzyıl University GOP Hospital
Deniz S Öztekin, Prof. study director
Istanbul University - Cerrahpasa
Nurgül Arpag, MSC study chair
Istanbul University - Cerrahpasa
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative visit of the operating room nurse and patient education in people with Postoperative Anxiety and Pain, run by Nurgül Arpag.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nurgül Arpag, MSC (+905326319262, nurgul.deveci@ogr.iu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Anxiety before and after surgery / State Trait Anxiety Scale I-II' Score (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2021.