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

NCT03784469 | Completed

• 1 other identifier: 201712022RIND
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Cancer; Transcatheter Arterial Chemoembolization

Keywords

Transcatheter Arterial Chemoembolization; position change; back pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Within 4 hours after TACE

Secondary Outcomes (6)

• The mean of back pain between two groups

  Within 4 hours after TACE

• The mean of back pain in the experimental group

  Within 4 hours after TACE

• The mean of back pain in the control group

  Within 4 hours after TACE

• Vascular complication

  Femoral puncture sites were assessed every hourly for the following 4 hours by researcher and a nurse.

• Post embolization syndrome

  Within 4 hours after TACE.

Study Arms (2)

Changing body position in bed

EXPERIMENTAL

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).

Other: Changing body position in bed

Control group

NO INTERVENTION

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

Interventions

Changing body position in bed 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).

Changing body position in bed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 32535341 DERIVED

MeSH Terms

Conditions

Liver Neoplasms; Back Pain

Interventions

Beds

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Equipment and Supplies, Hospital; Equipment and Supplies

Study Officials

• Tse-Pin Hsu, M.S.N.

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2018
• First Posted: December 24, 2018
• Study Start: February 21, 2018
• Primary Completion: August 28, 2018
• Study Completion: August 28, 2018
• Last Updated: October 21, 2019

Record last verified: 2018-02

Locations

TW (1)