Assessing the Efficacy of a Hope Intervention in Temporomandibular Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
研究概览
简要总结
The purpose of this study is to examine the effects of a hope-based intervention on clinical and experimental pain in individuals with temporomandibular disorder (TMD). To examine the effectiveness of this intervention, a two-arm randomized trial will be conducted with 50 individuals, between the ages of 18 and 65, who have TMD.
详细描述
In recent years, there has been increasing interest in the contribution of positive psychological factors (e.g., optimism, pain acceptance, hope) to pain and pain-related coping. Although research supports the significance of these resilience factors in pain adaptation, psychological interventions based upon bolstering resilience have received far less attention. Emerging evidence supports the role of hope in psychosocial adjustment and enhancement of adaptive pain coping skills. Hope is considered to be a positive motivational state consisting of one's belief in their ability to generate routes to achieve goals (pathways) and initiation towards attaining these goals (agency). In the context of pain, increasing hope may promote augmentation of personal strengths to enhance development of meaningful goal pursuits and foster resilient outcomes. Enhancement of hopeful thinking and behavior may ultimately lead to the minimization of losses that are often associated with chronic pain. This experience may be also reflected physiologically, as increasing hope may confer biological benefits (e.g., decreased inflammation). Although hope-based interventions have been successfully applied in other clinical conditions (i.e., cancer), their utility in chronic pain disorders has not been examined.
To examine the effectiveness of this approach, a two-arm randomized trial will be conducted with individuals who have TMD. In Study Arm 1, participants will receive hope-based therapy. In Study Arm 2, participants will receive pain education. Participants will attend 5 sessions over a period of 5 weeks. Two of these sessions will involve quantitative sensory pain testing; three sessions will include delivery of the treatment intervention. Pain outcomes will be measured at pre- and post-treatment.
Aims:
- Examine the degree to which state and trait levels of hope are predictive of clinical pain, disability, affective distress, and experimental pain.
- Investigate the effects of a hope intervention, as compared to an education control group, on clinical and experimental pain in individuals with TMD.
- Identify psychosocial (e.g., hope, optimism, positive affect, catastrophizing), biological (e.g., inflammatory, endogenous opioid, neuroendocrine), and psychophysical factors associated with positive treatment response (i.e., reduction of clinical pain).
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participants between the ages of 18 and 65
- •meets Research Diagnostic Criteria for TMD
- •duration of pain is at least 3 months
- •pain at least 15 days in the past month
- •pain rated moderate to severe in intensity
排除标准
- •uncontrolled hypertension
- •current heart disease including heart failure
- •kidney failure or currently undergoing dialysis
- •current neurological conditions that could affect protocol safety or validity
- •facial trauma or orofacial surgery within the last 6 months
- •currently in orthodontic treatment
- •currently pregnant and/or nursing
- •use of narcotic analgesics (i.e., opioids) on a daily basis
- •a primary pain condition other than TMD
结局指标
主要结局
Change from baseline in state hope on the 8-point Adult State Hope Scale at week 5
时间窗: Baseline, Week 5
The Adult State Hope Scale is a 6-item inventory used to assess goal-directed thinking at a given moment in time.
Change from baseline in clinical pain on the 0-100 Numerical Rating Scale at week 5
时间窗: Baseline, Week 5
0-100 Numerical Rating Scale used to assess clinical pain intensity.
次要结局
- Change from baseline in inflammatory, endogenous opioid, and neuroendocrine markers at week 5(Baseline, Week 5)
- Change from baseline in optimism on the 5-point Life Orientation Test - Revised (LOT-R) at week 5(Baseline, Week 5)
- Change from baseline in positive and negative affect on the 5-point Positive and Negative Affect Schedule (PANAS) scale at week 5(Baseline, Week 5)
- Change from baseline in pain catastrophizing on the 5-point Pain Catastrophizing Scale (PCS) at week 5(Baseline, Week 5)
- Change from baseline in sensory pain stimuli at week 5(Baseline, Week 5)
