AzTrials
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PainNCT03205579

Pain Education to Improve Cancer Pain Management Patients

A study testing Video group and conventional group in people with Pain and Inpatient, run by Mahidol University at 2 sites in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pain, Inpatient, Cancer
What is being tested?
Video group and conventional group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
2 sitesThailand
Study dates
20 Sep 2018to 18 Jul 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Thailand2 sites

  • Siriraj Hospital Mahidol University

    Bangkok, 10700

  • Faculty of medicine Siriraj Hospital Mahidol University

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Effectiveness of Pain Education to Improve Cancer Pain Management in Hospitalized Patients

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.

Read the 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.

Conditions
Pain, Inpatient, Cancer
Being tested
Video group, conventional group
Medical subject headings
Pain, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video groupOther

    Using video for educate cancer pain patients

  • conventional groupOther

    Face to face cancer pain education by trained nurse

Study groups in NCT03205579
Study groupRoleWhat they receive
Video groupExperimentalVideo cancer pain education (10 minutes ) the knowledge includes cancer pain definition, cancer pain treatment, pain assessment and role of patient in cancer pain management.
Receives: Other: Video group
Conventional groupActive comparatorFace 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.
Receives: Other: conventional group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: seven days

Secondary outcomes (2)

  1. 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).

    Measured: seven days

  2. 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.

    Measured: seven days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start20 Sep 2018
  3. Primary completion30 Sep 2019
  4. Study completion18 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Care provider
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03205579
Sponsor's protocol ID
Si231/2017
Status last verified
Aug 2022
First submitted
29 Jun 2017
Last updated
5 Aug 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 27501612

  • 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.

    PubMed 17355955

  • 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.

    PubMed 10222947

  • 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.

    PubMed 9669787

Questions about this trial

What is this clinical trial studying?

A study testing Video group and conventional group in people with Pain and Inpatient, run by Mahidol University at 2 sites in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain intensity (time frame: seven days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03205579, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.

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