Pain Education to Improve Cancer Pain Management Patients

Sponsor
Mahidol University (Other)
Overall Status
Completed
CT.gov ID
NCT03205579
Collaborator
(none)
48
2
2
45.9
24
0.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Video group
  • Other: conventional group
N/A

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

  1. patients' age 18-70 years old

  2. moderate to severe cancer pain

  3. ECOG(Eastern cooperative Oncology Group) performance status <= 3

  4. 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Pain Education to Improve Cancer Pain Management in Hospitalized Patients
Actual Study Start Date :
Sep 20, 2018
Actual Primary Completion Date :
Sep 30, 2019
Actual Study Completion Date :
Jul 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Video group

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.

Other: Video group
Using video for educate cancer pain patients

Active Comparator: Conventional group

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.

Other: conventional group
Face to face cancer pain education by trained nurse

Outcome Measures

Primary Outcome Measures

  1. Pain intensity [seven days]

    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

  1. Emotional status [seven days]

    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).

  2. Functional assessment [seven days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of medicine Siriraj Hospital Mahidol University Bangkoknoi Bangkok Thailand 10700
2 Siriraj Hospital Mahidol University Bangkok Thailand 10700

Sponsors and Collaborators

  • Mahidol University

Investigators

  • Principal Investigator: Suratsawadee Wangnamthip, md, Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mahidol University
ClinicalTrials.gov Identifier:
NCT03205579
Other Study ID Numbers:
  • Si231/2017
First Posted:
Jul 2, 2017
Last Update Posted:
Aug 5, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 5, 2022