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Pain Education to Improve Cancer Pain Management Patients

Primary Purpose

Pain, Inpatient, Cancer

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Video group
conventional group
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • moderate to severe pain (NRS>4) cancer pain
  • ECOG (Eastern cooperative Oncology group) performance status <=3
  • Can read, listen, write Thai language

Exclusion Criteria:

  • Clinical instability
  • Confusion and delirium
  • Bed ridden
  • Psychotic problem

Sites / Locations

  • Faculty of medicine Siriraj Hospital Mahidol University
  • Siriraj Hospital Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Video group

Conventional group

Arm Description

Video cancer pain education (10 minutes ) the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

Face to face cancer pain education by trained nurse (10 minutes)the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.

Outcomes

Primary Outcome Measures

Pain intensity
The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the first day and the seventh day of study

Secondary Outcome Measures

Emotional status
The emotional status of participants will be assessed and compared using Thai-HADs (Hospital Anxiety and Depression scale) between the first day and the seventh day of study. The score will be analyzed into depression and anxiety. the score 0-7 for either sub scale being in normal range, 8-10; being just suggestive of the presence of the respective state, a score of 11 or higher indicating probable presence of the mood disorder(Depression and Anxiety).
Functional assessment
Functional status will be assessed and compared using FACT-G between the first day and the seventh day of study. The subscale including physical well-being, social/family well-being, emotional well-being and functional well-being. Each items scored from 0-4; from 0 means "not at all" to 4 means "very much". The higher score would indicate better quality of life.

Full Information

First Posted
June 29, 2017
Last Updated
August 3, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT03205579
Brief Title
Pain Education to Improve Cancer Pain Management Patients
Official Title
Effectiveness of Pain Education to Improve Cancer Pain Management in Hospitalized Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2018 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
July 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

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

5. Study Description

Brief Summary
Cancer pain is one of the problems of treating cancer pain. Although, there is a WHO analgesic ladder to improve this problem, it is still inadequate pain control. Pain does not affect only physical but also emotional and quality of life. From review literatures we found that patients' knowledge about cancer pain management is inaccurate; for example, fear to use opioid, try to patience of pain, concerning only cancer treatments, which can cause of unfavorable pain management outcome. Therefore, we will conduct the RCT of using pain education by video comparing to conventional face to face pain education by nurse in hospitalized cancer pain patients.We will use 25 MCQs examination for testing pre-post intervention to test level of understanding of patients. The measurements are NRS, ThaiHADs and FACT-G at the first and last day of study. We expect that NRS should improve more than 50% at the seven day of study.
Detailed Description
protocol Randomized controlled trial study Sample size is 70 patients divided to 2 groups (35 for video group and 35 for conventional face to face group) Inclusion criteria patients' age 18-70 years old moderate to severe cancer pain ECOG(Eastern cooperative Oncology Group) performance status <= 3 Patients can write and read Thai language Exclusion criteria 1.Clinical unstability 2.Confusion and delirium 3.Bed ridden 4.Psychotic problem We will randomly allocate patients by using computer program nQuery advice 6.0. After patients sign inform consent we will record baseline characteristics, assess baseline Numerical rating scale (NRS), emotional status (ThaiHADs), Quality of life status (FACT-G). All patients will do the 25 MCQs test within 30 minutes before intervention. Video group will watch video 10 minutes and conventional group will receive pain education from trained nurse in the same period. The knowledge includes cancer pain definition, cancer pain management, pain assessment and role of patients in cancer pain management. After finishing intervention patients will the same 25 MCQs test (30 minutes) and patients can ask questions to the trained nurse. All patients will be educated to record pain diary everyday for seven days. All patients will receive standard pain management from the physicians. At the day seven we will assess NRS, ThaiHADs and FACT-G and finish the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Inpatient, Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Video group
Arm Type
Experimental
Arm Description
Video cancer pain education (10 minutes ) the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Face to face cancer pain education by trained nurse (10 minutes)the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.
Intervention Type
Other
Intervention Name(s)
Video group
Intervention Description
Using video for educate cancer pain patients
Intervention Type
Other
Intervention Name(s)
conventional group
Intervention Description
Face to face cancer pain education by trained nurse
Primary Outcome Measure Information:
Title
Pain intensity
Description
The pain reduction will be assessed and compared using numerical rating (NRS) from 0-10; 0 designating "no pain" and 10 designating " worst possible pain" scale between the first day and the seventh day of study
Time Frame
seven days
Secondary Outcome Measure Information:
Title
Emotional status
Description
The emotional status of participants will be assessed and compared using Thai-HADs (Hospital Anxiety and Depression scale) between the first day and the seventh day of study. The score will be analyzed into depression and anxiety. the score 0-7 for either sub scale being in normal range, 8-10; being just suggestive of the presence of the respective state, a score of 11 or higher indicating probable presence of the mood disorder(Depression and Anxiety).
Time Frame
seven days
Title
Functional assessment
Description
Functional status will be assessed and compared using FACT-G between the first day and the seventh day of study. The subscale including physical well-being, social/family well-being, emotional well-being and functional well-being. Each items scored from 0-4; from 0 means "not at all" to 4 means "very much". The higher score would indicate better quality of life.
Time Frame
seven days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: moderate to severe pain (NRS>4) cancer pain ECOG (Eastern cooperative Oncology group) performance status <=3 Can read, listen, write Thai language Exclusion Criteria: Clinical instability Confusion and delirium Bed ridden Psychotic problem
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suratsawadee Wangnamthip, md
Organizational Affiliation
Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Siriraj Hospital Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Siriraj Hospital Mahidol University
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
27501612
Citation
Wangnamthip S, Euasobhon P, Siriussawakul A, Jirachaipitak S, Laurujisawat J, Vimolwattanasarn K. Effective Pain Management for Inpatients at Siriraj Hospital: A Retrospective Study. J Med Assoc Thai. 2016 May;99(5):565-71.
Results Reference
result
PubMed Identifier
17355955
Citation
van den Beuken-van Everdingen MH, de Rijke JM, Kessels AG, Schouten HC, van Kleef M, Patijn J. Prevalence of pain in patients with cancer: a systematic review of the past 40 years. Ann Oncol. 2007 Sep;18(9):1437-49. doi: 10.1093/annonc/mdm056. Epub 2007 Mar 12.
Results Reference
result
PubMed Identifier
10222947
Citation
Yates P, Dewar A, Edwards H, Fentiman B, Najman J, Nash R, Richardson V, Fraser J. The prevalence and perception of pain amongst hospital in-patients. J Clin Nurs. 1998 Nov;7(6):521-30. doi: 10.1046/j.1365-2702.1998.00192.x.
Results Reference
result
PubMed Identifier
9669787
Citation
Gureje O, Von Korff M, Simon GE, Gater R. Persistent pain and well-being: a World Health Organization Study in Primary Care. JAMA. 1998 Jul 8;280(2):147-51. doi: 10.1001/jama.280.2.147. Erratum In: JAMA 1998 Oct 7;280(13):1142.
Results Reference
result

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Pain Education to Improve Cancer Pain Management Patients

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