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

NCT ID: NCT03784469

Last Updated: 2019-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-21
• Study Completion Date: 2018-08-28

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).

Conditions

Liver Cancer; Transcatheter Arterial Chemoembolization

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Changing body position in bed

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).

Group Type: EXPERIMENTAL

Changing body position in bed

Intervention Type: OTHER

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).

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Changing body position in bed

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tse-Pin Hsu, M.S.N.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

National Taiwan University Hospital

Taipei, , Taiwan

Countries

Taiwan

References

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.

Reference Type: DERIVED

PMID: 32535341 (View on PubMed)

Other Identifiers

201712022RIND

Identifier Type: -

Identifier Source: org_study_id