Long-term Effect of Hypnosis in Spinal Cord Injury Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Pain intensity
研究概览
简要总结
Coping-oriented hypnotic suggestions aimed at reducing pain catastrophizing was shown to reduce pain in people with chronic tension-type headache and experimental pain in healthy volunteers during hypnosis (Kjøgx et al., 2016). However, the duration of the effect on pain post-hypnosis is unknown.
The aim is to investigate the durational effect of a single session of coping-oriented hypnotic suggestions on chronic pain in patients with spinal cord injury. If effective for a longer period post-hypnosis, this form of hypnosis may provide an alternative to medicine or may be used in conjunction with lower medicine dosages.
Methods: 75 patients with spinal cord injury and pain is randomized into one of three conditions; coping-oriented hypnosis plus current treatment, neutral hypnosis plus current treatment or current treatment only. Pain intensity, coping strategies, pain catastrophizing, anxiety and depression is assessed before intervention and over a period of 14 days post-intervention.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Spinal cord injury (tetraplegia or paraplegia) with some preservation of hand functioning
- •Baseline pain level of ≥ 3 on a Numeric Rating Scale (NRS; 0-10 where 10 is extremely severe pain)
- •Pain duration of at least 8 weeks.
排除标准
- •Severe mental or psychiatric illness
- •Substance abuse (drugs, alcohol or medicine)
- •Lack of ability to cooperate during the experiment
- •Severe high cervical lesions
- •Severe autonomic dysautonomia
结局指标
主要结局
Pain intensity
时间窗: For 14 days post-intervention
NRS (0-10)
Coping
时间窗: For 14 days post-intervention
Coping strategies questionnaire
次要结局
- Pain catastrophizing(For 14 days post-intervention)
- Pain impact on mood, sleep and daily activities(For 14 days post-intervention)
- Global impression of change(For 14 days post-intervention)
- Anxiety(For 14 days post-intervention)
- Depression(For 14 days post-intervention)
研究者
Lone Knudsen, MSc Psych, PhD
Psychologist
Central Jutland Regional Hospital