Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT03784469
Status:
COMPLETED
Last Update Posted:
2019-10-21
First Post:
2018-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-02
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:
Changing patients' position in the bed after TACE can decrease the level of back pain without increasing the amount of bleeding and hematoma,bring patients some comfort and relieving abdominal bloating, increase patients' satisfaction.
Detailed Description:
Background：During the treatment for the liver cancer patients who are treated by Transcatheter Arterial Chemoembolization (TACE), the embolic agent with chemotherapeutic drugs are injected through a catheter into a femoral artery directly supplying the tumor. Hence, after the procedure, to avoid bleeding and hematoma at the puncture site, the puncture site at groin needs to be pressed by sandbag and the affected limb needs to remain straight. These patients have to lay down on beds and are not allowed to move for at least 4 hours. Due to pressure exerted continuously to the same muscles, may cause back muscle rigidity and spasms, these patients may suffer from back pain and discomfort. In addition to usual pharmacological treatment, nursing intervention aimed at decreasing patient discomfort, therefore, this study will refer to the previous researches to develop the methods and procedures of changing body positions and apply these methods to the liver cancer patients who are treated by TACE.
Purpose：The aim of this study was to compare the level of back pain and on the amount of bleeding and hematoma between those patients changing body positions in bed and those patients not changing body positions after TACE.
Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who had undergone TACE via the femoral artery, patients by using a convenience sampling assigned to either the control or experimental group (each group consisting 39 participants). All patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2 hours and lie down for 4 hours. The control group received the usual care, remaining supine position in complete bed rest and immobilized. Experimental group patients received position changes in the second hour and the fourth hour after TACE.
Results: The overall trend of back pain is different between the two groups ( p \<.001) , the mean of pain intensity in the second ( p =.006) and the forth hour ( p \<.001) showed a significant difference. Experimental group patients had significantly less back pain than the control group after TACE . For the within subjects factor of time, the levels of back pain differed significantly across the five-time periods in experimental group ( p \< .05) . In the aspect of post embolization syndrome , control group patients had significantly abdominal bloating than the experimental group ( p =.003) . None of patients developed hematoma, there was no significant difference between the two groups in terms of amount of bleeding. On the whole, experimental group patients had significantly higher satisfaction than the control group ( p =.018).
Purpose：The aim of this study was to compare the level of back pain and on the amount of bleeding and hematoma between those patients changing body positions in bed and those patients not changing body positions after TACE.
Methods: This study was a randomized clinical trial. The sample consisted of 78 patients who had undergone TACE via the femoral artery, patients by using a convenience sampling assigned to either the control or experimental group (each group consisting 39 participants). All patients need to be pressed on the puncture site at groin with a sand bag of 2.5 kg for 2 hours and lie down for 4 hours. The control group received the usual care, remaining supine position in complete bed rest and immobilized. Experimental group patients received position changes in the second hour and the fourth hour after TACE.
Results: The overall trend of back pain is different between the two groups ( p \<.001) , the mean of pain intensity in the second ( p =.006) and the forth hour ( p \<.001) showed a significant difference. Experimental group patients had significantly less back pain than the control group after TACE . For the within subjects factor of time, the levels of back pain differed significantly across the five-time periods in experimental group ( p \< .05) . In the aspect of post embolization syndrome , control group patients had significantly abdominal bloating than the experimental group ( p =.003) . None of patients developed hematoma, there was no significant difference between the two groups in terms of amount of bleeding. On the whole, experimental group patients had significantly higher satisfaction than the control group ( p =.018).
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?: