Pain Education to Improve Cancer Pain Management Patients

NCT ID: NCT03205579

Last Updated: 2022-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-20
• Study Completion Date: 2022-07-18

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

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Video group

Intervention Type: OTHER

Using video for educate cancer pain patients

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.

Group Type: ACTIVE_COMPARATOR

conventional group

Intervention Type: OTHER

Face to face cancer pain education by trained nurse

Interventions

Video group

Using video for educate cancer pain patients

Intervention Type: OTHER

conventional group

Face to face cancer pain education by trained nurse

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mahidol University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suratsawadee Wangnamthip, md

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, Faculty of Medicine Siriraj Hospital, Mahidol University

Locations

Faculty of medicine Siriraj Hospital Mahidol University

Bangkoknoi, Bangkok, Thailand

Siriraj Hospital Mahidol University

Bangkok, , Thailand

Countries

Thailand

References

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.

Reference Type: RESULT

PMID: 27501612 (View on PubMed)

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.

Reference Type: RESULT

PMID: 17355955 (View on PubMed)

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.

Reference Type: RESULT

PMID: 10222947 (View on PubMed)

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.

Reference Type: RESULT

PMID: 9669787 (View on PubMed)

Other Identifiers

Si231/2017

Identifier Type: -

Identifier Source: org_study_id