Ignite Creation Date:
2024-05-06 @ 8:15 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06310928
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-02-13
Brief Title:
The Effect of Thermal Blanket After Peripheral Artery Surgery
Sponsor:
Saglik Bilimleri Universitesi
Organization:
Saglik Bilimleri Universitesi
Study Overview
Official Title:
The Effect of Thermal Blanket Applied to the Area After Peripheral Artery Surgery on Circulation Pain and Mobilization
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Peripheral arterial disease is one of the most common clinical conditions associated with cardiovascular morbidity and increased mortality requiring exercise antiaggregant and surgical revascularization therapy As in peripheral arterial surgery postoperative hypothermia is common in patients who have undergone surgical intervention and the duration of surgery is longer than 30 minutes due to the low temperature of the surgical environment or the suppression of the thermoregulation center by anesthetics and sedatives With hypothermia heat loss increasesperipheral vasoconstriction with activation of the sympathetic system impaired perfusion at the surgical wound site hypoxemia coagulopathy bleeding postoperative pain deterioration of thermal comfort deterioration of patient comfort and prolonged hospital stay are reported Many heating methods are used to achieve and maintain normal body temperature in the postoperative period to prevent complications caused by hypothermiaAluminum-coated thermal blankets are especially preferred In this way heat preservation peripheral vasodilation and perfusion with the effect of temperature reduction of muscle spasm with increased endorphin release less pain and increased comfort of the patient are provided The thermal blanket is an easy-to-apply material that does not require any tools or electricity for its effectiveness and can come into direct contact with the patients skin It provides thermal insulation with its ability to reflect thermal radiation Peripheral vasodilation and decreased peripheral vascular resistance have been observed with thermal therapy provided by thermal blankets It is known that thermal blanket methods are used to warm patients in practice However the lack of a literature study on the regional effect of these applications on the patient has been noticed For this purpose in this study the regional efficacy of thermal blankets on the patient was evaluated in order to reduce the narrowed arterial lumen and increased peripheral vascular resistance in peripheral arterial diseases and to prevent the vasoconstrictive effect of hypothermia on peripheral vessels It was predicted that these blankets would maintain heat increase tissue perfusion with peripheral vasodilation effect facilitate circulation reduce pain and facilitate mobilizationIn line with this aim the objectives are
To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery
To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery
To increase the patients postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming
To contribute to the control of pain neurovascular follow-up and reduction of damage and mobilization which are the main nursing goals after surgery
To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets thus providing an easy-to-apply effective care in terms of nursing and increasing the quality of health care service
Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patients circulation pain and mobilization
To increase peripheral tissue perfusion and decrease neurovascular damage by using thermal blankets for heating after peripheral arterial surgery
To reduce the degree of surgical wound site and ischemic pain by using thermal blankets for warming after peripheral arterial surgery
To increase the patients postoperative mobility and mobilization by using thermal blankets in peripheral artery postoperative warming
To contribute to the control of pain neurovascular follow-up and reduction of damage and mobilization which are the main nursing goals after surgery
To increase the comfort of the patient by utilizing the heat insulation and flexible effect of thermal blankets thus providing an easy-to-apply effective care in terms of nursing and increasing the quality of health care service
Research Design This study is a randomized controlled trial to determine the effect of a thermal blanket applied to the area after peripheral arterial surgery on the patients circulation pain and mobilization
Detailed Description:
The population of the study consisted of patients who were planned to undergo peripheral artery surgery under elective conditions in the Cardiovascular Surgery Clinic of Seyrantepe Hamidiye Etfal Training and Research Hospital between 2022 and 2024 The sample consisted of a total of 60 patients who would undergo interventional peripheral arterial surgery met the study criteria and agreed to participate in this study They will be divided into two groups as 30 experimental group and 30 control group by randomization method Data will be collected by Patient Identification Form Visual Analog Scale VAS-Visual Analog Scale Neurovascular Identification Form Patient Mobility Scale and Observer Mobility Scale
In the implementation phase of the study intensive care and clinical nurses will be informed about this study after obtaining institutional permission Before the study the patients will be informed by the researcher and after the written consent of the patients who meet the criteria for participation in the study and accept the study is obtained with the Informed Voluntary Consent Form respectively
The patient will be diagnosed with the Patient Identification Form
After the admission of the patient in the postoperative intensive care unit and the vital signs will be stabilized
General body heating of both patient groups will be done with the hot air blowing system Forced-air which is an active heating method
In the intervention group a digital temperature probe will be fixed to the treated area just before the application of the thermal blanket 30th minute of active heating and the temperature will be monitored for 24 hours
In the 30th minute of the active heating method a thermal blanket will be applied to the treated area extremity of the intervention group and this application will remain for 24 hours In the control group cotton dressings routinely used by the clinic will be used
The first 24 hours after application of the thermal blanket
every hour for the first 8 hours
every 2 hours for the second 8 hours
In the last 8 hours pain will be evaluated every 4 hours with VAS Pain Scale and circulation will be evaluated with Neurovascular Diagnostic Form in both groups
At the end of the 8th hour of the thermal blanket application the patients first mobilization will be evaluated in both groups with the Patient Mobility and Observer Mobility Scale
At the end of the 24th hour of the thermal blanket application the second mobilization assessment of the patient will be made in both groups with the Patient and Observer Mobility Scale together with pain and circulation
24 hours after surgery both groups will be transferred to the Cardiovascular Surgery Clinic without any application
On the second postoperative day pain circulation with the neurovascular diagnostic form and mobilization with the Patient and Observer Mobility Scale will be evaluated every 12 hours in both groups
At the end of 48 hours mobilization will be evaluated for the last time with the Patient Mobility and Observer Mobility Scale
The data obtained in the study will be analyzed using SPSSStatistical Package for Social Sciences for Windows 220 program
In the implementation phase of the study intensive care and clinical nurses will be informed about this study after obtaining institutional permission Before the study the patients will be informed by the researcher and after the written consent of the patients who meet the criteria for participation in the study and accept the study is obtained with the Informed Voluntary Consent Form respectively
The patient will be diagnosed with the Patient Identification Form
After the admission of the patient in the postoperative intensive care unit and the vital signs will be stabilized
General body heating of both patient groups will be done with the hot air blowing system Forced-air which is an active heating method
In the intervention group a digital temperature probe will be fixed to the treated area just before the application of the thermal blanket 30th minute of active heating and the temperature will be monitored for 24 hours
In the 30th minute of the active heating method a thermal blanket will be applied to the treated area extremity of the intervention group and this application will remain for 24 hours In the control group cotton dressings routinely used by the clinic will be used
The first 24 hours after application of the thermal blanket
every hour for the first 8 hours
every 2 hours for the second 8 hours
In the last 8 hours pain will be evaluated every 4 hours with VAS Pain Scale and circulation will be evaluated with Neurovascular Diagnostic Form in both groups
At the end of the 8th hour of the thermal blanket application the patients first mobilization will be evaluated in both groups with the Patient Mobility and Observer Mobility Scale
At the end of the 24th hour of the thermal blanket application the second mobilization assessment of the patient will be made in both groups with the Patient and Observer Mobility Scale together with pain and circulation
24 hours after surgery both groups will be transferred to the Cardiovascular Surgery Clinic without any application
On the second postoperative day pain circulation with the neurovascular diagnostic form and mobilization with the Patient and Observer Mobility Scale will be evaluated every 12 hours in both groups
At the end of 48 hours mobilization will be evaluated for the last time with the Patient Mobility and Observer Mobility Scale
The data obtained in the study will be analyzed using SPSSStatistical Package for Social Sciences for Windows 220 program
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None