Chronic Pain Clinical Trial
Official title:
The Effectiveness of a Dyadic Pain Management Program for Older People and Informal Caregivers With Chronic Pain: A Pilot Randomized Controlled Trial
Chronic pain is a common health problem among older adults and their informal caregivers.
Chronic pain has negative effects on physical and psychological health status and it is a
strong predictor of poor quality of life. In this study, a dyadic face-to-face pain
management program will be provided to older adults and informal caregivers to help the dyads
equip with pain-related knowledge and pain coping skills. The effectiveness of the dyadic
program will be assessed. Participants will be recruited follow snowball sampling and will be
randomly allocated to experimental group and control group using 1: 1 radio. The dyadic pain
management program will last four weeks, including group discussion, pain-related knowledge
and physical exercises. Pain intensity, anxiety, depression, stress, pain self-efficacy and
quality of life will be measured in baseline, post-treatment and at one-month follow.
Acceptability and satisfaction to the program will be collected.
This study will be held in Caritas District Elderly Centre-Yeun Long (Tin Chak Centre) and
Caritas Cheng Shing Fung District Elderly Center (Shamshuipo) in Hong Kong. For sample size,
no suitable standard deviation and effect size was found in previous similar study through
the literature review, so this study will be a pilot RCT study with a total 60 dyads of
sample size. 30 older adults and 30 informal caregivers will be in each group (experimental
group and control group). The dyadic pain management program will be held in the community
activity center at weekends and will involve three parts: demographic data, outcome measures
(baseline, post-treatment and one-month follow-up measures) and pain education.
Potential participants' eligibility will be confirmed by a questionnaire designed according
to inclusion criteria and exclusion criteria. An information sheet will be provided to the
eligible dyads and informed consent will be signed on the scene. Experimental group will
start pain management program when finish the baseline assessment and control group will be
given one page of pain management information download from Department of Health.
(http://www.elderly.gov.hk/english/common_health_problems/bones_and_joints/index.html). For
optimal communication, two WhatsApp groups will be created consisting of all the caregivers
in experimental group and control group respectively.
Outcomes will be measured at three times during the whole intervention, T0 baseline prior to
intervention, T1 in week four when the experimental group finish all the program and T2 in
week eight with one-month follow-up after the program. Dyads' demographic and
caregiving-related questions will be completed prior to beginning the program in T0. Pain
related situations, anxiety, depression, stress, quality of life, pain self-efficacy will be
measured from older adults and informal caregivers at T0, T1, T2, using a same battery of
questionnaires. Dyads' acceptability and satisfaction will be administered immediately after
the last session. Data will be collected by a research assistant blinded to the dyads' group
assignments.
Participants
This study is a dyadic intervention. Target populations are older adults and informal
caregivers with chronic pain. A pair of informal caregiver and older adult will be regarded
as a dyad. Dyads will be recruited in the community following the snowball sampling, the
eligibility will be accessed based on the following details:
Older adults
Inclusion criteria for older adults:
1. Aged 65 or above;
2. Have an informal caregiver willing to participate this program;
3. Can understand Chinese;
4. Have a history of non-cancer pain in past 6 months;
5. Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric
scale ;
6. Have behavioral abilities to do a light exercise and stretch program;
7. Able to attend the whole sessions in community activity center.
Exclusion criteria for older adults:
1. Have serious organic disease or malignant tumor;
2. Have a history of consciousness or mental disorder diagnosed by neurologists or
psychiatrists;
3. Have a further medical/surgical treatment in two months or have joined in other pain
management program.
4. Experience a drug addiction problem
Informal caregivers Inclusion criteria for informal caregivers
1. Aged 18 or above;
2. As an informal caregiver for one older adult;
3. Can understand Chinese;
4. Have a history of non-cancer pain in past 6 months;
5. Pain score should be at least 2 measured by Numeric Rating Scale, a 11-point numeric
scale ;
6. Own a smartphone and can assess the internet;
7. Able to attend the whole sessions in community activity center.
Exclusion criteria for informal caregivers
1. Have serious organic disease or malignant tumor;
2. Have a history of consciousness or mental disorder diagnosed by neurologists or
psychiatrists;
3. Have a further medical/surgical treatment in two months or have joined in other pain
management program.
4. Experience a drug addiction problem
Outcome measures It is a dyadic intervention so outcomes will be measured from older adults
and informal caregivers.
Primary outcome The Brief Pain Inventory-Chinese Version It is a tool to evaluate the
intensity, site, quality, relief, interference and causes of pain in patients. Four items for
the degree of pain severity, one item for the degree of pain relief and seven items for
degree of pain interferes will assess, numbering the different pain sites from 0 to 10. For
BPI-C, the Cronbach's α for the pain severity and pain interference items are 0.83-0.89 and
0.90-0.91 and has good acceptable test-retest reliability .
Secondary outcomes:
World Health Organization Quality of Life-Brief It is a self-report questionnaire which
assesses 4 domains of quality of life, including physical health, psychological health,
social relationships, and environment. Participants will express how much they have
experienced in the preceding two weeks on a 5-point Likert scale ranging from 1 (not at all)
to 5 (completely). Previous studies showed that WHOQOL-BRIF has good internal consistency and
validity.
Depression Anxiety Stress Scale It is a self-administered psychological instrument to
evaluate the degree of depression, anxiety and stress involving 21 items. Every part has
seven items on a 4-point Likert scale ranging from 0 to 3. The instrument was used in
previous studies and had good internal consistency and validity.
Pain Self-efficacy Questionnaire It is a tool to measure the self-efficacy in coping with
daily activities with pain . A Chinese version of the PSEQ will be used in this study.
Participants will express participants' confidence in performing ten activities experiencing
pain on a 7-point Likert scale ranging from 0 (not at all confident) to 6 (completely
cinfident). Previous studies illustrated the test-rest reliability coefficient of PSEQ was
0.75 and internal consistency, Cronbach's alpha was 0.95, which was reliable .
Satisfaction and acceptability Participants' satisfaction and acceptability of the dyadic
intervention will be assessed at the end of the grogram. Some open-ended questions will be
asked, including "What topics, content, or concepts could have been covered in more/less
detail?" "As a result of participating in dyadic pain management intervention, did you make
some positive changes in your life?" "Would you feel the group discussions interesting and
informative? Did the activities and exercises relieve your pain symptom?" These questions
were used in previous studies to evaluate the satisfaction and acceptability of intervention
program.
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