A Pilot Randomized Controlled Trial Exploring the Use of Supervised Group Art Therapy Among Older Adults With Chronic Low Back Pain: Feasibility, Potential Efficacy, and Participant Experiences
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Recruitment rate
研究概览
简要总结
This research project aims to assess the feasibility of expressive art therapy for elderly adults with chronic low back pain and to evaluate the preliminary efficacy of combining art therapy with exercise intervention. Additionally, the study will investigate facilitators and barriers to participation.
A mixed-methods approach will be employed, including a quantitative questionnaire and qualitative semi-structured focus group discussions. The questionnaire will examine physical, functional, and psychological changes potentially influenced by art therapy, while the focus groups will provide in-depth insights into participants' experiences and perceptions of the combined intervention.
详细描述
Chronic low back pain (CLBP) is a common and debilitating condition that affects millions of older adults worldwide, significantly impacting their physical, emotional, and social well-being. This pilot randomized controlled trial (RCT) aims to explore the feasibility and potential effectiveness of a new approach that combines supervised group expressive art therapy with exercise for elderly individuals suffering from CLBP.
The primary goal is to assess participant recruitment, retention, and adherence to intervention. The investigators will also identify any logistical challenges that may arise during the process. To gather preliminary data on the intervention's effectiveness, the investigators will measure changes in pain intensity, functional ability, psychological flexibility, and health-related quality of life (HRQoL).
In addition to quantitative measures, the investigators will conduct qualitative interviews and focus groups to gain deeper insights into the participants' experiences. This will help to identify factors that facilitate or hinder their engagement with the program.
By incorporating expressive art therapy-an approach that encourages emotional expression and coping strategies-this study aims to provide a holistic method for managing pain. The ultimate goal is to enhance the quality of life for older adults affected by CLBP. If successful, this pilot RCT will offer valuable insights that could inform a larger, definitive RCT, paving the way for innovative, interdisciplinary strategies in chronic pain management and improving health outcomes in the community.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 60 years and above
- •currently experiencing non-specific low back pain for at least three months
- •who have sought medical treatment for CLBP
- •can read and write in Traditional Chinese
- •MoCA-5 of 18 or above
排除标准
- •malignant pain
- •lumbar spinal stenosis
- •confirmed dementia
- •severe cognitive impairment
- •serious major medical or psychiatric disorders
- •currently receiving physiotherapy, cognitive therapy, or psychological treatments
研究组 & 干预措施
Experimental: Expressive art therapy
One hour of expressive art therapy followed by exercise session.
干预措施: Exercise (Other)
Control Group: Exercise
The control group will be a one-hour session that includes progressive back strengthening and general reconditioning exercises, complemented by education on back care to support self-management of low back pain.
干预措施: Art therapy combined with Exercise (Other)
结局指标
主要结局
Recruitment rate
时间窗: Baseline
The proportion of eligible participants who agree to enrol in the study.
Proportion of Participants Adhering to Intervention
时间窗: Weekly from week 1 through 8
Intervention adherence will be assessed by the proportion of participants who attended at least 80% of the scheduled group sessions out of the total number randomized. Reasons for non-adherence will be explored through qualitative interviews with participants who did not meet the attendance threshold or discontinued the program prematurely.
Retention Rate of participants
时间窗: Through study completion, an average of 8 weeks
The proportion of participants who complete the full study protocol.
Acceptability of the Intervention-willingness to continue
时间窗: Weekly from week 1 through 8
Participants will rate their willingness to continue with the program on a scale from 0 (not willing to continue) to 10 (very willing to continue).
Feasibility of data collection procedures
时间窗: At 3-month post intervention
This outcome measure will evaluate the feasibility and acceptability of the data collection methods used in the study, including completion rates for outcome assessments. Feasibility Metrics: Completion Rates for Outcome Assessments: The number of completed assessments will be divided by the total number of scheduled assessments to calculate the completion rate.
Acceptability of the Intervention-satisfaction
时间窗: Weekly from week 1 through 8
Participants will rate their satisfaction with the program on a scale from 0 (not satisfied) to 10 (very satisfied).
Acceptability of the Intervention-perceived burden
时间窗: Weekly from week 1 through 8
Participants will rate the perceived burden of the intervention on a scale from 0 (not demanding) to 10 (very demanding).
Safety and Adverse Events of participants
时间窗: Weekly from week 1 through 8
This outcome measure will document any adverse events or safety concerns that arise during the study, including: Undesirable medical occurrences or problems that a participant experiences during or after the intervention, lasting more than 2 days and/or causing the participant to seek additional treatment. These adverse events will be categorized into: Serious Related Adverse Events Non-Serious Adverse Events Safety Metrics: Number and type of adverse events Proportion of participants who report serious related adverse events Proportion of participants who report non-serious adverse events
次要结局
- Acceptance and Action Questionnaire II (AAQ-II)(Baseline, immediately post-intervention, and 3 month follow up post-intervention)
- Global Impression of Change scale(Immediately post-intervention and at the 3-month follow-up post-intervention)
- Numeric Pain Rating Scale (NPRS)(Baseline, immediately post-intervention, and 3 month follow up post-intervention)
- EQ-5D-5L(Baseline, immediately post-intervention, and 3 month follow up post-intervention)
- Roland Morris Disability Index (RMDQ)(Baseline, immediately post-intervention, and 3 month follow up post-intervention)
- Depression, Anxiety, and Stress Scales (DASS)(Baseline, immediately post-intervention, and 3 month follow up post-intervention)
研究者
Prof. Fadi AL ZOUBI
Assistant Professor
The Hong Kong Polytechnic University