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Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC

Primary Purpose

Liver Cancer, Transcatheter Arterial Chemoembolization

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Changing body position in bed
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Liver Cancer focused on measuring Transcatheter Arterial Chemoembolization, position change, back pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patient with hepatocellular carcinoma hospitalized for TACE .
  2. Age ≧ 18.
  3. Consciousness can be communicated in Mandarin and Taiwanese.

Exclusion Criteria:

  1. Symptoms of back pain before TACE.
  2. Under the treatment of analagesics within 24 hours before TACE.
  3. Anticoagulant was not discontinued for at least 7 days before TACE.
  4. Inguinal hemorrhage or hematoma during the TACE or before removal of the vascular sheath.
  5. Hemological diseases that are prone to bleeding, i.e. hemophilia and leukemia.
  6. Platelet count lower than 70K or INR (international normalized ratio) is greater than 1.4.
  7. No hemostatic cotton use.
  8. Can not change the position in bed after TACE.

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Changing body position in bed

Control group

Arm Description

The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).

No changing body position in bed,remaining supine position in complete bed rest and immobilized for four hours.

Outcomes

Primary Outcome Measures

The overall trend of back pain
The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.

Secondary Outcome Measures

The mean of back pain between two groups
The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS).To determine if there is any significant difference the two groups.
The mean of back pain in the experimental group
To determine if there is any significant difference across the five-time periods in experimental group.
The mean of back pain in the control group
To determine if there is any significant difference across the five-time periods in control group.
Vascular complication
The hematoma in femoral access site or there is blood on the yarn roll were visually checked, its margin was marked by a marker and its size was measured by using measuring paper. (The area equal to a square that is 1 millimeter on each side).
Post embolization syndrome
This is a dichotomized variable. Various common symptoms were listed and checked off based on the patient's report.
Patients' satisfaction
5-Point Likert Scale: with scores of 5, 4, 3, 2, and 1 indicating highly satisfied, satisfied, neutral, dissatisfied, and highly dissatisfied, respectively. Higher scores mean higher satisfaction.

Full Information

First Posted
December 20, 2018
Last Updated
October 17, 2019
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03784469
Brief Title
Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC
Official Title
Effectiveness of Positioning on Back Pain After Transcatheter Arterial Chemoembolization Among Patients With Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
February 21, 2018 (Actual)
Primary Completion Date
August 28, 2018 (Actual)
Study Completion Date
August 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Transcatheter Arterial Chemoembolization
Keywords
Transcatheter Arterial Chemoembolization, position change, back pain

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Changing body position in bed
Arm Type
Experimental
Arm Description
The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No changing body position in bed,remaining supine position in complete bed rest and immobilized for four hours.
Intervention Type
Other
Intervention Name(s)
Changing body position in bed
Intervention Description
The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
Primary Outcome Measure Information:
Title
The overall trend of back pain
Description
The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS-11).To determine if there is any significant difference the two groups. The NRS-11 with scores of 0 and 10 indicating no pain and excruciating pain, respectively.
Time Frame
Within 4 hours after TACE
Secondary Outcome Measure Information:
Title
The mean of back pain between two groups
Description
The patients were asked to describe their back pain and rate its severity by using the Numerical Rating Scale (NRS).To determine if there is any significant difference the two groups.
Time Frame
Within 4 hours after TACE
Title
The mean of back pain in the experimental group
Description
To determine if there is any significant difference across the five-time periods in experimental group.
Time Frame
Within 4 hours after TACE
Title
The mean of back pain in the control group
Description
To determine if there is any significant difference across the five-time periods in control group.
Time Frame
Within 4 hours after TACE
Title
Vascular complication
Description
The hematoma in femoral access site or there is blood on the yarn roll were visually checked, its margin was marked by a marker and its size was measured by using measuring paper. (The area equal to a square that is 1 millimeter on each side).
Time Frame
Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.
Title
Post embolization syndrome
Description
This is a dichotomized variable. Various common symptoms were listed and checked off based on the patient's report.
Time Frame
Within 4 hours after TACE.
Title
Patients' satisfaction
Description
5-Point Likert Scale: with scores of 5, 4, 3, 2, and 1 indicating highly satisfied, satisfied, neutral, dissatisfied, and highly dissatisfied, respectively. Higher scores mean higher satisfaction.
Time Frame
Patient's satisfaction will be evaluated at the 4th hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patient with hepatocellular carcinoma hospitalized for TACE . Age ≧ 18. Consciousness can be communicated in Mandarin and Taiwanese. Exclusion Criteria: Symptoms of back pain before TACE. Under the treatment of analagesics within 24 hours before TACE. Anticoagulant was not discontinued for at least 7 days before TACE. Inguinal hemorrhage or hematoma during the TACE or before removal of the vascular sheath. Hemological diseases that are prone to bleeding, i.e. hemophilia and leukemia. Platelet count lower than 70K or INR (international normalized ratio) is greater than 1.4. No hemostatic cotton use. Can not change the position in bed after TACE.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tse-Pin Hsu, M.S.N.
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
32535341
Citation
Chang KT, Liu CJ, Tsai HT, Hsu TP, Chen PT, Hu SH. Effects and safety of body positioning on back pain after transcatheter arterial chemoembolization in people with hepatocellular carcinoma: A randomized controlled study. Int J Nurs Stud. 2020 Sep;109:103641. doi: 10.1016/j.ijnurstu.2020.103641. Epub 2020 May 16.
Results Reference
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Effectiveness of Positioning on Back Pain After TACE Among Patients With HCC

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